Adalimumab

Articles · Refrigerated Storage · Lactation Safety Information · New Medicines · Published , updated

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Articles

Refrigerated Storage

Humira · AbbVie

AbbVie
Humira
40 mg solution for injection pre-filled syringe, pre-filled pen

In the event of an inadvertent temperature excursion the following data may be used:

A single Humira pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days. The syringe or pen must be protected from light, and discarded if not used within the 14 -day period

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

For information outside of this excursion, contact AbbVie Ltd directly. Refer to the current BNF for company contact details.

17th April 2019
London MI Service

Amgevita · Amgen Ltd

Amgen Ltd
Amgevita
Solution for injection in pre-filled syringe/pen

In the event of an inadvertent temperature excursion the following data may be used:
The pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days. The pre-filled syringe or pre-filled pen must be protected from light, and discarded if not used within the 14-day period.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

14 days
29th July 2019
London MI Service

Imraldi · Biogen

Biogen
Imraldi
Solution for injection in a pre-filled pen or syringe

Once exposed to temperatures up to 25°C, the syringe or pen must be used within 28 days or discarded, even if it is returned to the refrigerator.

You should record the date when the syringe or pen is first removed from refrigerator, and the date after which it should be discarded.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

28 days
Yes
London MI Service

Lactation Safety Information

For rheumatoid arthritis

For rheumatoid arthritis
Caution
See summary
Moderate amount of published evidence of safety indicates small amounts in breast milk which are likely to be degraded in the infant’s GI tract
Long half-life increases risk of accumulation in breastfed infants
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
Safety in Lactation: Drugs which suppress the rheumatic disease process
15th September 2019
Bibliography

For inflammatory bowel disease

For inflammatory bowel disease
Caution
See summary
Safety in lactation: Drugs for chronic bowel disorders
15th September 2019
Bibliography

New Medicines

Amgevita · Rheumatoid arthritis (RA) and other Humira indications

Information

Amgevita
Biosimilar
Amgen
Amgen

Development and Regulatory status

Launched
Launched
Licensed but not launched
October 2018
Oct 18 · Amgevita 20mg/0.4ml soln for inj in pre-filled syringe, Price =£158.40. Amgevita 40mg/0.8ml soln for inj in pre-filled syringe or pre-filled pen, Price =£633.60 [17].
Oct 18 · Amgevita launched in markets across Europe on 16th October 2018 [16].
Sep 17 · Under a new settlement with AbbVie, Amgen has agreed to wait until end Jan 2023 before launching its adalimumab biosimilar (Amjevita) in the US. Launch in Europe is expected Oct 2018 [15].
Mar 17 · Approved in EU for all indications of originator product [14].
Jan 17 · EU positive opinion for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis [13].
Sep 16 · Approved in the US for all eligible indications of its reference product, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn´s disease and moderate-to-severe ulcerative colitis. The approval follows analytical, nonclinical, pharmacokinetic and clinical data showing biosimilarity between Amjevita and Humira, including results from two PIII studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients which met their primary endpoint showing clinical and safety equivalence [11].
Jul 16 · The FDA recommends approval of ABP 501 in all available indications to the reference product [10].
Jan 16 · The FDA accepts the application for ABP 501, with a final decision expected by Sep 25. Amgen hope ABP 501 will be approved for all Humira indications. However, launch in the US may be delayed. The US Patent and Trademark Office has declined to review a pair of AbbVie patents that Amgen contends are invalid, a blow to Amgen plans to market its biosimilar by 2017. Amgen has promised to challenge those patents in court, but AbbVie believes its legal protection will keep Humira safe from competition until 2022 [9].
Dec 15 · Filed in the EU using PIII data in which ABP-501 met primary and secondary endpoints of improving RA symptoms at a rate similar to Humira with a comparable safety profile [8].
Nov 15 · Filed in the US [7].
Feb 15 · Patents covering adalimumab will expire in 2016 in the US and in 2018 in the EU [4].
Feb 13 · Amgen announce it aims to begin launch of its adalimumab biosimilar in 2017 [4].

Category

A biosimilar version of adalimumab, a humanised recombinant monoclonal IgG1 antibody targeting tumour necrosis factor (TNF)-α.
NICE suggest the benchmark rate for the number of people with RA eligible for and receiving biologic drugs is 86 per 100,000 adults per year
Rheumatoid arthritis (RA) and other Humira indications
Subcutaneous

Trial or other data

01. Oct 13: Amgen is to start a PIII multicentre, double-blind, randomized trial of its biosimilar version of adalimumab (ABP 501) vs the reference product Humira, in patients suffering from severe rheumatoid arthritis. The primary outcome is ACR20 at week 24. The trial, which is expected to take 11 months, will be conducted in Argentina, Bulgaria, Canada, Czech Republic, Germany, Hungary, Mexico, Poland, Romania, Russia, Spain, UK and the US and will include 500 patients, aged 18 years and above. EudraCT Number: 2013-000525-31 [1].
02. The PIII study is also registered on clinicaltrials.gov as study NCT01970475. The study will enrol 500 subjects and is due to complete Aug 15.
03. Apr 14: NCT02114931 is an an open-label, single-arm PIII extension study to evaluate the long-term safety and efficacy of ABP 501 in 425 subjects with moderate to severe rheumatoid arthritis. The study starts Apr 14 and is due to complete Feb 17 [2]
04. Feb 15: Positive top-line results from PIII study evaluating efficacy and safety of Abp 501 vs. Humira® (adalimumab) in 526 adult pts with moderate-to-severe RA who have an inadequate response to methotrexate (MTX).. This randomised, double-blind, active-controlled study (20120262) evaluated safety, efficacy and immunogenicity of ABP 501 (n=264) compared to adalimumab (n=262) given subcutaneously every 2 weeks. The study consisted of; a screening period of 4 weeks, a treatment period of 22 weeks and a safety follow-up period through to week 26. The primary endpoint, assessment of ACR20 at week 24, was met as well as key secondary endpoints (ACR50, ACR70 and DAS 28-CRP). The ACR20 was within the prespecified margin for ABP 501 compared to adalimumab, showing clinical equivalence. Safety and immunogenicity of ABP 501 were comparable to adalimumab [3].
05. Sep 15: Study with EudraCT Number: 2013-000525-31 involving 500 patients with rheumatoid arthritis completed Nov 14, no results currently available.[5]
06. Nov 15: Amgen presented detailed findings from a head-to-head Phase 3 study comparing the safety, efficacy and immunogenicity of ABP 501 with adalimumab in patients with moderate-to-severe RA, at the 2015 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Francisco. The study met the primary endpoint, which was achievement of ACR20 (20% or greater improvement in ACR assessment) at week 24. At week 24, 74.6% of patients in the ABP 501 group and 72.4% in the adalimumab group met the ACR20 response criteria. The risk ratio of ACR20 was 1.039 with the two-sided 90 percent CI of 0.954–1.133, which fell within the predefined equivalence margin [6].
07. Nov 15: Further details from the PIII (20120262) study announced. Secondary endpoints included the achievement of ACR50 and ACR70 (a 50 or 70 percent improvement in ACR assessment) within the predefined equivalence margin. At week 24, patients treated with ABP 501 compared with those treated with adalimumab achieved ACR50 (49.2% vs. 52.0%) and ACR70 (26.0% vs. 22.9%, respectively. Additionally, the secondary endpoint of a difference in change from baseline of DAS28-CRP (Disease Activity Score examines 28 joints in the body as measured by C reactive protein in the blood) over the entire study was also achieved. The difference in mean change from baseline in DAS28-CRP between ABP 501 and adalimumab was –0.01 (90% CI, –0.18 to 0.17) at week 24. The incidence of treatment-emergent adverse events (TEAEs) was 50 percent for ABP 501 and 55 percent for adalimumab. The most frequently reported TEAEs (for ABP 501 and adalimumab, respectively) were nasopharyngitis (6.4% vs. 7.3%), headache (4.5% vs. 4.2%), arthralgia (3.0% vs. 3.4%), cough (2.7% vs. 3.1%) and upper respiratory tract infection (1.5% vs. 3.8%). Serious adverse events (3.8% vs. 5.0%) and serious infections (0.8% vs. 1.1%) were reported in patients treated with ABP 501 and adalimumab, respectively. By the end of week 24, binding antibodies (38.3% vs. 38.2%) and neutralizing antibodies were identified (9.1% vs. 11.1%) in patients treated with ABP 501 and adalimumab, respectively [6].
08. Oct 16: results of trial NCT01970475 that compared ABP 501 with adalimumab (Humira) in patients with moderate-severe RA found those who achieved ACR 20 was similar with the two treatments, 74.6% vs 72.4% respectively [12].

Evidence based evaluations

Amgevita EPAR
SMC
Solymbic EPAR

Amgevita · Psoriasis and other Humira indications

Information

Amgevita
Biosimilar
Amgen
Amgen

Development and Regulatory status

Launched
Launched
Licensed but not launched
October 2018
Oct 18 · Amgevita 20mg/0.4ml soln for inj in pre-filled syringe, Price =£158.40. Amgevita 40mg/0.8ml soln for inj in pre-filled syringe or pre-filled pen, Price =£633.60. [16]
Oct 18 · Amgevita launched in markets across Europe on 16th October 2018 [16].
Sep 17 · Under a new settlement with AbbVie, Amgen has agreed to wait until end Jan 2023 before launching its adalimumab biosimilar (Amjevita) in the US. Launch in Europe is expected Oct 2018 [14].
Mar 17 · Approved in EU for all indications of originator product [13].
Jan 17 · EU positive opinion for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis [12].
Sep 16 · Approved in the US for all eligible indications of its reference product, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn´s disease and moderate-to-severe ulcerative colitis. The approval follows analytical, nonclinical, pharmacokinetic and clinical data showing biosimilarity between Amjevita and Humira, including results from two PIII studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients which met their primary endpoint showing clinical and safety equivalence [11].
Jul 16 · The FDA recommends approval of ABP 501 in all available indications to the reference product [9]
Jan 16 · The FDA accepts the application for ABP 501, with a final decision expected by Sep 25. Amgen hope ABP 501 will be approved for all Humira indications. However, launch in the US may be delayed. The US Patent and Trademark Office has declined to review a pair of AbbVie patents that Amgen contends are invalid, a blow to Amgen plans to market its biosimilar by 2017. Amgen has promised to challenge those patents in court, but AbbVie believes its legal protection will keep Humira safe from competition until 2022 [9].
Dec 15 · Filed in the EU. Amgen´s MAA submission includes analytical, clinical and pharmacokinetic data. PIII comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe RA, which met their primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP-501 were also comparable to adalimumab in both studies. Data to support the transition of adalimumab patients to ABP-501 are included in the submission. [7].
Nov 15 · Filed in the US [6].
Feb 15 · Patents covering adalimumab will expire in 2016 in the US and in 2018 in the EU [4].
Feb 13 · Amgen announce it aims to begin launch of its adalimumab biosimilar in 2017 [4]

Category

A biosimilar version of adalimumab, a humanised recombinant monoclonal IgG1 antibody targeting tumour necrosis factor (TNF)-α.
Plaque psoriasis is the most common type of psoriasis, representing 90% of cases. Around 2-3% of the overall UK population have psoriasis and it is estimated that 1.4% of all people between the ages of 10 and 19 are affected. Approximately 1.1% of people with plaque psoriasis have severe disease.
Psoriasis and other Humira indications
Subcutaneous

Trial or other data

Oct 16 · PIII study to compare efficacy of ABP501 with adalimumab in moderate-severe psoriasis (NCT01970488) found comparable efficacy; 80.91% vs 83.06% met primary outcome of improvement in PASI from baseline to week 16 [11].
Sep 15 · The phase III, multicenter, randomized, double-blind study evaluating the efficacy and safety of ABP 501 compared with adalimumab (Humira) in 350 subjects with moderate to severe plaque psoriasis (NCT01970488) completed in March 2015 (Primary completion date was July 2014)Primary Outcome Measure was: Psoriasis Area and Severity Index (PASI) % improvement after 16 weeks; secondary endpoint was PASI response at week 50. No results currently available[5].
Oct 14 · Amgen announces ABP 501 met trial outcomes of equivalent efficacy and safety for treating plaque psoriasis in the first of two planned PIII studies comparing its follow-on drug with Humira. Humira loses patent protection in the US in 2016 and in Europe in 2018 [3].
Oct 13 · The PIII study is also registered on the clinicaltials.gov website as study NCT01970488. The study is due to complete Mar 16 (primary data collection Aug 15).
Oct 13 · EudraCT Number: 2013-000537-12 is a PIII, multicentre, randomized, double-blind study evaluating the efficacy and safety of ABP 501 vs adalimumab in 340 subjects with moderate to severe plaque psoriasis. The primary efficacy endpoint is PASI % improvement from baseline at week 16. The trial will be conducted in Poland, Australia, Canada, France, Germany and Hungary and started Sep 13 [1].

Evidence based evaluations

Amgevita EPAR
Solymbic EPAR

Hyrimoz · Psoriasis and other Humira indications

Information

Hyrimoz
Biosimilar
Sandoz
Sandoz

Development and Regulatory status

Launched
Launched
Approved (licensed)
October 2018
Nov 18 · Hyrimoz approved by FDA for rheumatoid arthritis, juvenile idiopathic arthritis in patients four years of age and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn´s disease, ulcerative colitis and plaque psoriasis. Despite the approval, Hymiroz will not be available in the US until 2023, under terms of intellectual property-related litigation with AbbVie [13].
Oct 18 · Following patent disputes, Sandoz announce agreement with AbbVie to delay launch of its adalimumab biosimilar in the US until Sept 2023 [12].
Oct 18 · Launched in the UK. Cost for 2 x 40mg/0.8ml soln for inj in pre-filled syringe or pre-filled pen=£646.18 [11].
Jul 18 · Approved in the EU [10].
May 18 · Recommended for EU approval by CHMP - indications encompass those of Humira, but differ in detail between the three brand names [9].
Dec 17 · Currently pre-registration in US [8].
Jun 17 · Filed in EU [6].
Sep 16 · EU filing planned 2017 [3].
Sep 16 · Filings planned in the US 2016 [3].
Feb 15 · Patents covering adalimumab will expire in 2016 in the US and in 2018 in the EU [2].

Category

A biosimilar version of adalimumab, a humanised recombinant monoclonal IgG1 antibody targeting tumour necrosis factor (TNF)-α.
Plaque psoriasis is the most common type of psoriasis, representing 90% of cases. Around 2-3% of the overall UK population have psoriasis and it is estimated that 1.4% of all people between the ages of 10 and 19 are affected. Approximately 1.1% of people with plaque psoriasis have severe disease.
Psoriasis and other Humira indications
Subcutaneous

Trial or other data

Sep 17 · Sandoz present data from PIII NCT02016105 (ADACCESS) at conference. PASI 75 response rates for patients receiving biosimilar adalimumab continuously throughout the study were 75.2% at Week 17 and 84.5% at Week 51, compared with 67.8% and 79.6%, respectively, for patients receiving continuous Humira [7].
Mar 17 · PIII trial to compare efficacy and safety of GP2017 and Humira in plaque psoriasis confirmed equivalent efficacy by demonstrating PASI 75 response rates of 67% for GP2017and 65% for Humira after 16 weeks treatment in patients with moderate to severe, chronic plaque psoriasis [5].
Sep 16 · PIII trial to compare efficacy and safety of GP2017 and Humira in plaque psoriasis completed (NCT02016105), no results available [4].
Sep 15 · Patient enrolment complete [2].
NCT02016105 a randomized, double-blind, multicentre study to demonstrate equivalent efficacy and to compare safety and immunogenicity of a biosimilar adalimumab (GP2017) and Humira® in 448 patients with moderate to severe chronic plaque-type psoriasis. The primary outcome is PASI 75 response rate at week 17. The study starts Dec 13 and is due to complete Dec 15 (primary outcome data collection Jun 15). The trial will support registration in the US and EU [1].

Hyrimoz · Rheumatoid arthritis (RA) and other Humira indications

Information

Hyrimoz
Biosimilar
Sandoz
Sandoz

Development and Regulatory status

Launched
Launched
Approved (licensed)
October 2018
Nov 18 · Hyrimoz approved by FDA for rheumatoid arthritis, juvenile idiopathic arthritis in patients four years of age and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn´s disease, ulcerative colitis and plaque psoriasis. Despite the approval, Hymiroz will not be available in the US until 2023, under terms of intellectual property-related litigation with AbbVie [9].
Oct 18 · Following patent disputes, Sandoz announced agreement with AbbVie concerning the proposed biosimilar for reference medicine Humira which means launch in the US will be delayed until Sept 2023 [8].
Oct 18 · Launched in the UK. Cost for 2 x 40mg/0.8ml soln for inj in pre-filled syringe or pen=£646.18 [7].
Jul 18 · Approved in the EU [6].
May 18 · Recommended for EU approval by CHMP - indications encompass those of Humira, but differ in detail between the three brand names [5].
Jan 18 · FDA accept Biologics License Application (BLA) for filing for adalimumab biosimilar [5].
Dec 17 · Currently pre-registration in US [4].
Jun 17 · Filed in EU [3].
Sep 16 · EU filing planned for 2017 [2].
Sep 16 · US filing planned for 2016 [2].

Category

A biosimilar version of adalimumab, a humanised recombinant monoclonal IgG1 antibody targeting tumour necrosis factor (TNF)-α.
NICE suggest the benchmark rate for the number of people with RA eligible for and receiving biologic drugs is 86 per 100,000 adults per year
Rheumatoid arthritis (RA) and other Humira indications
Subcutaneous injection

Trial or other data

Mar 16 · NCT02744755 is a PIII randomized, double-blind study to demonstrate similar efficacy and to compare safety and immunogenicity of GP2017 and Humira® in 308 patients with moderate to severe active rheumatoid arthritis. The study started in Mar 16 and is due to complete Oct 17. Primary outcome data on change in DAS28-CRP score at week 12 will be collected by Feb 17 [1].

Imraldi · Rheumatoid arthritis (RA) and other Humira indications

Information

Imraldi
Biosimilar
Biogen
Merck & Co (name used in US for MSD)

Development and Regulatory status

Launched
Launched
Approved (Licensed)
October 2018
Aug 19 · Samsung Bioepis announced on 24 July 2019 that it had received approval from the US Food and Drug Administration (FDA) for its adalimumab biosimilar (SB5, Hadlima (adalimumab-bwwd)) [14].
Oct 18 · Launched in EU [11].
Oct 18 · Launched in UK. Adalimumab 40mg/0.8ml soln for inj in pre-filled syringe or pre-filled pen, Price = £633.85 [12].
Sep 18 · Filing accepted in US [13].
Apr 18 · AbbVie announces global resolution of Humira (adalimumab) patent disputes with Samsung Bioepis. Under the terms of the agreement, Imraldi may be launched in Europe from Oct 18. Merck & Co, Samsung´s commercialisation partner for the US, can launch in Jun 23 [9,10].
Aug 17 · Approved in EU [7].
Jun 17 · EU positive opinion for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohns disease, paediatric Crohns disease, ulcerative colitis and uveitis [6].
Jul 16 · SB5 has been accepted for review by the EMA [4].
Nov 15 · The 24-week PIII study of SB5, which randomised 544 pts with moderate to severe RA despite methotrexate therapy, showed ACR20 response rate of 72.5% in the SB5 arm vs. 72.0% in the Humira® arm. The safety profile of SB5 was comparable to Humira® [3].
Jul 15 · Samsung Bioepis and Merck intend to file applications for the approval of adalimumab by 2016 [2].
Feb 13 · Merck & Co. and Samsung Bioepis enter into an agreement. Samsung Bioepis has responsibility for preclinical and clinical development, process development and manufacturing, clinical trials and registration; Merck & Co. has responsibility for commercialisation worldwide excluding the territories of the EU, Russia and Turkey [1].

Category

A biosimilar version of adalimumab (SB 5), a humanised recombinant monoclonal IgG1 antibody targeting tumour necrosis factor (TNF)-α.
NICE suggest the benchmark rate for the number of people with RA eligible for and receiving biologic drugs is 86 per 100,000 adults per year.
Rheumatoid arthritis (RA) and other Humira indications
Subcutaneous injection

Trial or other data

01. Apr 14: Samsung Bioepis initiates a PIII trial to evaluate safety, efficacy, tolerability, pharmacokinetics and immunogenicity of its adalimumab biosimilar, compared with Humira in adult and elderly patients with moderate to severe RA (SB5-G31-RA; EudraCT2013-005013-13). The primary objective of the study is to demonstrate the equivalence of the two agents in terms of response rate at week 24. The trial will enrol approximately 490 patients. Enrolment has begun in Lithuania, Bulgaria and Poland, and will extend to other countries [2].
02. Jul 15: Samsung Bioepis announces SB5 met its main goal of measuring up to adalimumab in a PIII study on patients with RA, charting at least a 20% average improvement in symptoms after 24 weeks [1].
03. Jul 16: PIII study lasting 62 weeks randomised 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy to either SB5 or adalimumab (Humira). Results at 24-weeks showed ACR20 response rate of 72.5% in the SB5 arm versus 72.0% in the adalimumab arm. The safety profile of SB5 was comparable to adalimumab and the incidence of anti-drug antibody was 15.7% in the SB5 group and 18.3% in the Humira group [4].
04. Aug 16: PIII trial where 508 patients with rheumatoid arthritis were randomized in a 1:1 ratio to receive either SB5 or Humira (adalimumab) 40 mg every other week. At Week 24, 254 patients from SB5 continued to receive SB5 (SB5/SB5), 125 patients from Humira were transitioned to SB5 (adalimumab/SB5) and 129 patients from Humira continued to receive Humira (adalimumab/adalimumab). At Week 52, the efficacy, safety and immunogenicity profiles were comparable, with ACR20 response rates of 76.9%, 81.1% and 71.2%, respectively. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by switching. At week 52, the incidence of anti-drug antibodies was 15.7% in SB5/SB5, 16.8% in adalimumab/SB5 and 18.3% in adalimumab/adalimumab [5].
05. Nov 17: Results of 24-week PIII study of SB5 (NCT02167139) published in Arthritis and Rheumatology [8].

Evidence based evaluations

EPAR
NICE

Hulio · Rheumatoid arthritis (RA) and other Humira indications

Information

Hulio
Biosimilar
Mylan
Astra-Fujifilm Kyowa Kirin Biologics joint venture

Development and Regulatory status

Licensed but not launched
Launched
Phase III Clinical Trials
Oct 19 · Not currently being marketed; plans for UK launch not available [10].
Oct 18 · Mylan N.V. announced that it has initiated the commercial launch of Hulio across major markets in Europe [9].
Sep 18 · Launch anticipated mid Oct 2018 [8].
Sep 18 · Approved in the EU [7].
Jul 18 · EU positive opinion for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn´s disease in adults and children, ulcerative colitis and uveitis in adults and children [6].
May 17 · The European Medicines Agency (EMA) accepted the Marketing Authorisation Application (MAA) for FKB327, an adalimumab biosimilar, for review on May 18, 2017 [4].

Category

Tumour necrosis factor (TNF) inhibitor
NICE suggest the benchmark rate for the number of people with RA eligible for and receiving biologic drugs is 86 per 100,000 adults per year
Rheumatoid arthritis (RA) and other Humira indications
Subcutaneous

Trial or other data

Mar 17 · Pharmacokinetic similarity of FKB327 with Humira demonstrated in healthy subjects (n=180). FKB327 was well tolerated with AE´s similar to Humira (EudraCT 2012–005140-23) [3].
Jul 16 · PIII efficacy/safety trial completed in rheumatoid arthritis (NCT0220791), no study results posted [3].
Jul 15 · PIII ARABESC-OLE open extension trial in 480 patients started, to evaluate the safety/efficacy/immunogenicity of adalimumab biosimilar in patients who completed the ARABESC trial [2].
Jan 15 · PIII ARABESC efficacy/safety trial comparing FKB-327 with Humira in 600 patients with rheumatoid arthritis inadequately controlled on methotrexate (EudraCT2014-000109-11; NCT02260791) in US/Canada, Germany, Spain, and other countries [1].

Evidence based evaluations

EPAR

Idacio, Kromeya · Rheumatoid arthritis (RA) and other Humira indications

Information

Idacio, Kromeya
Biosimilar
Fresenius Kabi Biotech
Fresenius Kabi Biotech

Development and Regulatory status

Licensed but not launched
Launched
Phase III Clinical Trials
May 19 · Launched in Germany, where it is available as a pre-filled syringe, pre-filled pen and in a vial presentation [9].
Apr 19 · Fresenius announced on 3 April 2019 that it had received European Commission (EC) approval for its adalimumab biosimilar MSB11455 (Idacio) [8].
Apr 19 · Fresenius announced on 3 April 2019 that it had received European Commission (EC) approval for its adalimumab biosimilar MSB11455 (Idacio) [8].
Jan 19 · Proposed licensed indications include treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, axial spondyloarthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis [7].
Jan 19 · Recommended for EU approval by CHMP - indicated for rheumatoid arthritis and other indications of Humira [7].
Dec 18 · Fresenius Kabi plans to launch adalimumab biosimilar in Europe in H1 2019 [6].
Dec 17 · Preregistration for psoriasis, PIII for RA [5].
Apr 17 · Merck KgA announces it is divesting its biosimilar business to Fresenius, closing expected H2 2017 [4].
Feb 16 · PIII trial (AURIEL-PsO; NCT02660580) trial of MSB11022 for the treatment of moderate to severe chronic plaque psoriasis initiated in Germany [2].

Category

A biosimilar version of adalimumab, a humanised recombinant monoclonal IgG1 antibody targeting tumour necrosis factor (TNF)-α.
NICE suggest the benchmark rate for the number of people with RA eligible for and receiving biologic drugs is 86 per 100,000 adults per year
Rheumatoid arthritis (RA) and other Humira indications
Subcutaneous injection

Trial or other data

Mar 16 · Merck KGaA announce first patient treated in adalimumab biosimilar candidate study[3].
Feb 16 · AURIEL-PsO (NCT02660580) will compare the safety, efficacy and immunogenicity of MSB 11022 to Humira® and will enrol approximately 406 patients in Germany; enrolment is expected to expand in the US, Bulgaria, Canada, Czech, Estonia, France, Germany, Hungary, Mexico, Poland, Romania, Russia and the UK [2].

Fyzoclad · Rheumatoid arthritis (RA) and other Humira indications

Information

Fyzoclad
Biosimilar
Pfizer
Pfizer

Development and Regulatory status

Filing withdrawn
Filing withdrawn
Phase III Clinical Trials

Dec 18: Pfizer have withdrawn their EU Marketing Authorisation Application during the early stages of its assessment by CHMP: the reason given by the company is a change of strategy, although they reserve the right ro re-submit an application in future [8].

Category

A biosimilar version of adalimumab, a humanised recombinant monoclonal IgG1 antibody targeting tumour necrosis factor (TNF)-α.
NICE suggest the benchmark rate for the number of people with RA eligible for and receiving biologic drugs is 86 per 100,000 adults per year
Rheumatoid arthritis (RA) and other Humira indications
Subcutaneous

adalimumab biosimilar (CHS1420) · Psoriasis and other Humira indications

Information

adalimumab biosimilar (CHS1420)
Biosimilar
Coherus Biosciences
Coherus Biosciences

Development and Regulatory status

Phase III clinical trials
Phase III clinical trials
Phase III clinical trials

Category

A biosimilar version of adalimumab, a humanised recombinant monoclonal IgG1 antibody targeting tumour necrosis factor (TNF)-α.
Psoriasis and other Humira indications
Subcutaneous injection

adalimumab biosimilar (CT-P17) · Rheumatoid arthritis (RA) and other Humira indications

Information

adalimumab biosimilar (CT-P17)
Biosimilar
Celltrion
Celltrion

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Tumour necrosis factor (TNF) inhibitor, citrate-free double concentrate (reduced volume) formulation
In the UK the population minimum prevalence of RA was 1.16% in women and 0.44% in men in one study [2].
Rheumatoid arthritis (RA) and other Humira indications
Parenteral

Cyltezo · Rheumatoid arthritis (RA) and other Humira indications

Information

Cyltezo
Biosimilar
Boehringer Ingelheim
Boehringer Ingelheim

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Licensed but not launched
Dec 18 · Boehringer Ingelheim has said that it will not commercialize its approved adalimumab biosimilar Cyltezo (BI 695501) in Europe and is discontinuing all biosimilar development activities outside the US [12].
Nov 17 · Approved in EU [12].
Sep 17 · EU positive opinion for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn´s disease, ulcerative colitis and uveitis [11].
Aug 17 · Approved in US [10].
Jan 17 · Company announces that both the EMA and the FDA have accepted regulatory filings for BI695501 adalimumab biosimilar - the media release states that the product is intended for treatment of ´inflammatory diseases´ but doesn´t indicate whether it has been filed for one indication or for all those currently licensed for Humira [8].
Apr 15 · PIII [2].
Oct 13 · PI study conducted in New Zealand [1].

Category

A biosimilar version of adalimumab, a humanised recombinant monoclonal IgG1 antibody targeting tumour necrosis factor (TNF)-α.
Prevalence ranges from 0.5-1.5% of the population in industrialised countries. The incidence of the condition is low, with around 1.5 men and 3.6 women developing RA per 10,000 people per year.
Rheumatoid arthritis (RA) and other Humira indications
Subcutaneous

Trial or other data

Mar 18 · Results of VOLTAIRE-RA equivalence study (NCT02137226) published. RCT (n=645) found BI 695501 demonstrated similar efficacy, safety and immunogenicity to Humira. At week 12, 61.1% and 67.0%, respectively, achieved ACR20; at week 24 corresponding values were 64.5% and 69.0%. Switching from Humira to BI 695501 had no impact on efficacy and safety [11].
Jul 17 · Boehringer Ingelheim announced that the first patient has been enrolled into its VOLTAIRE-X interchangeability study. The goal of the study is to demonstrate that BI 695501 is interchangeable with the U.S.-marketed formulation of Humira® 40 mg/0.8 mL. This is the first study in the U.S. to investigate an interchangeability designation for an adalimumab biosimilar candidate. The study will compare the pharmacokinetics and clinical outcomes between patients receiving Humira continuously, versus those who switch repeatedly between Humira and BI 695501, Boehringer Ingelheim’s adalimumab biosimilar candidate. The study will also assess safety, immunogenicity and efficacy [9].
Oct 16 · Boehringer Ingelheim announces BI 695501 shows similar efficacy and safety profile to Humira® in pivotal PIII study NCT02137226. In this 48 week RCT (n=645) both primary efficacy endpoint (to establish equivalence with Humira®) and secondary endpoints (efficacy, safety and immunogenicity of BI 695501 vs. Humira®) were met [7].
Nov 15 · Recruitment to PIII trial of BI 695501 vs adalimumab lasting 48 weeks in patients with rheumatoid arthritis is now complete [6].
Sep 15 · A PIII trial investigating efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis (EUDRA-CT no 2012-002945-40) started in Sept 2014 involving 600 patients in Germany Hungary Spain Estonia and Bulgaria and is ongoing. Outcomes include Disease Activity Score in 28 joints (DAS28) [5].
Jun 15 · PIII NCT02137226 study is currently recruiting. It is expected to complete collection of primary outcome data in Apr 2016 [4].
Jan 15 · Boehringer Ingelheim initiates a PIII study to evaluate efficacy, safety and immunogenicity of BI-695501 compared to commercially available adalimumab sourced from the US, in adult and elderly patients with RA (NCT02137226). The primary endpoints will be change from baseline in DAS 28 and proportion of patients achieving ACR 20, both at 24 weeks. The global trial will enrol 650 patients. Enrolment has begun in Germany, Hungary, Estonia, Bulgaria, Poland and Spain [3].
Oct 13 · NCT01505491 is a randomized, open-label, single dose, parallel arm, active comparator PI study of the pharmacokinetics and safety of BI 695501 in 193 healthy subjects. The study was conducted in New Zealand. It started in Dec 11 and completed Jul 12 [1].

Evidence based evaluations

EPAR

Cyltezo · Psoriasis and other Humira indications

Information

Cyltezo
Biosimilar
Boehringer Ingelheim
Boehringer Ingelheim

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Licensed but not launched
Dec 18 · Boehringer Ingelheim has said that it will not commercialize its approved adalimumab biosimilar Cyltezo (BI 695501) in Europe and is discontinuing all biosimilar development activities outside the US [7].
Nov 17 · Approved in EU [6].
Sep 17 · EU positive opinion for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn´s disease, ulcerative colitis and uveitis [5].
Aug 17 · Approved in US [4].
Jan 17 · Company announces that both the EMA and the FDA have accepted regulatory filings for BI695501 adalimumab biosimilar - the media release states that the product is intended for treatment of ´inflammatory diseases´ but doesn´t indicate whether it has been filed for one indication or for all those currently licensed for Humira [2].

Category

A biosimilar version of adalimumab, a humanised recombinant monoclonal IgG1 antibody targeting tumour necrosis factor (TNF)-α.
Psoriasis and other Humira indications
Subcutaneous

Trial or other data

Sep 18 · PIII study (NCT 02850965), 318 patients between 18 and 78 years of age with moderate-to-severe chronic plaque psoriasis who had not previously received treatment with a biologic, were randomized to receive Cyltezo or Humira 80 mg in a 16 week trial. The primary endpoint, proportion of patients in each group achieving PASI-75 was met. The 24-week data from this study are expected to be presented next year [6].
Jul 17 · Boehringer Ingelheim initiates a PIII study (NCT03210259) to evaluate efficacy, safety and immunogenicity of BI-695501 compared to Humira in patients with plaque psoriasis. The trial will compare the pharmacokinetics and clinical outcomes between patients receiving Humira® continuously, vs those who switch repeatedly between Humira® and BI 695501 [3].
Oct 16 · PIII study to evaluate efficacy safety and immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis now started (NCT02850965), with primary outcome PASI 75 response at week 16 [1].

Evidence based evaluations

EPAR

adalimumab biosimilar (AVT02) · Rheumatoid arthritis (RA), ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s Disease.

Information

adalimumab biosimilar (AVT02)
Biosimilar
Alvotech/Cipla Gulf
Alvotech/Cipla Gulf

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

TNF inhibitor
NICE suggest the benchmark rate for the number of people with RA eligible for and receiving biologic drugs is 86 per 100,000 adults per year
Rheumatoid arthritis (RA), ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s Disease.
Subcutaneous injection

adalimumab biosimilar (M923) · Psoriasis and other Humira indications

Information

adalimumab biosimilar (M923)
Biosimilar
Momenta
Baxalta

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Sep 19 · Momenta Pharmaceuticals Inc announced its financial results for the second quarter of 2019 on 2 August 2019. In this, they reported that they will stop the development of their Humira (adalimumab M923) [5].

Category

A biosimilar version of adalimumab, a humanised recombinant monoclonal IgG1 antibody targeting tumour necrosis factor (TNF)-α.
Psoriasis is a common, chronic relapsing autoimmune-mediated inflammatory skin disorder. The prevalence of psoriasis is estimated to be about 1.3-2.2% in the UK. Plaque psoriasis accounts for 90% of all people with psoriasis, the majority of cases first present before the age of 35 [2].
Psoriasis and other Humira indications
Subcutaneous injection

adalimumab biosimilar (M923) · Rheumatoid arthritis (RA) and other Humira indications

Information

adalimumab biosimilar (M923)
Biosimilar
Baxter
Baxalta

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Sep 19 · Momenta Pharmaceuticals Inc announced its financial results for the second quarter of 2019 on 2 August 2019. In this, they reported that they will stop the development of their Humira (adalimumab M923) [5].

Category

A biosimilar version of adalimumab, a humanised recombinant monoclonal IgG1 antibody targeting tumour necrosis factor (TNF)-α.
NICE suggest the benchmark rate for the number of people with RA eligible for and receiving biologic drugs is 86 per 100,000 adults per year
Rheumatoid arthritis (RA) and other Humira indications
Subcutaneous injection

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