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Safety in Lactation: Other antineoplastic drugs

23 September 2020Antineoplastic agents, whether used as monotherapy or in combination with other antineoplastics, are contra-indicated in breastfeeding (unless indicated below) because of their effects on dividing…
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Refrigerated Storage

AvastinRoche Products Ltd

Roche Products Ltd
Avastin
25mg/ml concentrate for solution for infusion

Contact Roche Products Ltd in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

28 September 2020
London MI Service

Lactation Safety Information

No
No published evidence of safety
Serious adverse effects reported in adults
Low levels anticipated in milk due to the drug’s properties and likely to be degraded in infant’s GI tract. However, the effects on the infant of even small amounts in breast milk are unknown
16 September 2020

New Medicines

ZirabevCancer, multiple types in adults: metastatic colorectal, non-squamous non-small cell lung, renal cell carcinoma, and persistent, recurrent or metastatic cervical cancers

Information

Zirabev
Biosimilar
Pfizer
Pfizer

Development and Regulatory status

Launched
Launched
Approved (Licensed)
July 2020
Jul 20Launched in the UK [12].
Nov 19Launch not expected until patent of originator product expires [12].
Jul 19Pfizer Inc. announced the United States (U.S.) Food and Drug Administration(FDA) has approved bevacizumab-bvzr (Zirabev)[11].
Feb 19Approved in EU [10].
Dec 18Is also pre-registration in the US [9].
Dec 18Recommended for EU approval by CHMP - note that the indications do not include all those of the originator product. The full indications are "Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Zirabev in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Zirabev, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Zirabev in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Zirabev, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1)". It is proposed that Zirabev be prescribed by physicians experienced in the treatment of cancer.[8].
Dec 18The CHMP has adopted a positive opinion, recommending marketing authorization for ZIRABEV™ (bevacizumab) [7].
Mar 18Bevacizumab biosimilar has been filed in EU using centralised procedure; assume it to be this product [6].

Category

Monoclonal antibody that inhibits vascular endothelial growth factor (VEGF)
UK incidence of advanced NSCLC is 40 per 100,000 people; 25% are able to have first-line therapy, of these 20-40% may receive second-line therapy.
Cancer, multiple types in adults: metastatic colorectal, non-squamous non-small cell lung, renal cell carcinoma, and persistent, recurrent or metastatic cervical cancers
Intravenous infusion

Trial or other data

Dec 18PIII 3 REFLECTIONS B739-03 comparative study demonstrated clinical equivalence and found no clinically meaningful differences between ZIRABEV and Avastin in patients with advanced non-squamous NSCLC [7].
Jul 17Pfizer announce positive top-line results from REFLECTIONS B7391003 (NCT02364999) study. RCT (n=719) demonstrated equivalence in primary endpoint of objective response rate of PF-06439535 vs. Avastin, taken in combination with carboplatin/paclitaxel, for the first line treatment of patients with advanced non-squamous NSCLC [4].
Dec 16PIII trial comparing PF-6439535 with Avastin (NCT02364999) estimated completion date Dec 17 [3].
Jul 15Phase III randomised double blind trial started April 2015 to compare efficacy and safety of bevacizumab biosimilar with originator product in 798 patients in the US. Bevacizumab combined with paclitaxel and carboplatin will be used for first-line treatment of patients with advanced (unresectable, locally-advanced, recurrent or metastatic) non-squamous non-small cell lung cancer. Primary endpoint is response rate at 19 weeks [1].

Evidence based evaluations

AybintioCancer including colorectal, lung, breast, kidney and ovarian

Information

Aybintio
Biosimilar
Organon
Samsung Bioepsis

Development and Regulatory status

Launched
Launched
Pre-registration (Filed)
October 2020
Oct 20Available in the UK, Price = 100mg/4ml x 1 vial =£218.39 400mg/16ml x 1 vial =£831.96. [12,13,14]
Aug 20The EC has granted marketing authorization for AYBINTIO® (bevacizumab) for the treatment of the same types of cancer as reference bevacizumab [11].
Jun 20Recommended for EU approval by CHMP - approval covers all indications of the originator product: Treatment of adults with metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer, advanced and/or metastatic renal cell cancer, epithelial ovarian, fallopian tube, or primary peritoneal cancer and persistent, recurrent, or metastatic carcinoma of the cervix [10].
Nov 19Samsung Bioepis has announced that FDA have accepted an abbreviated BLA (aBLA) for its bevacizumab biosimilar (SB8) [7].
Jul 19Samsung Bioepis announce EMA has accepted MAA [6].
Aug 17Patent expiry including paediatric extension 06/20 [3]

Category

VEGF-A inhibitor that can slow the growth of new blood vessels in tumours
Cancer including colorectal, lung, breast, kidney and ovarian
Intravenous infusion

Trial or other data

Dec 18PIII trial comparing SB8 with Avastin (NCT02754882) anticipated completion date still Dec 18 [5].
Feb 18Recruitment for PIII trial completed Dec 17 [4].
Jan 17PIII trial comparing SB8 with Avastin in advanced non small cell lung cancer (NCT02754882) has estimated completion date Dec 2018 [2].
May 16PIII trial (EudraCT 2015-004026-34) starting in Europe Russia and Taiwan comparing SB8 with Avastin in 678 patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). The study will compare efficacy, safety, pharmacokinetics and immunogenicity of the two agents over 24 weeks. Secondary objectives for the trial include evaluation of the efficacy of SB8 compared to Avastin in terms of progression-free survival, overall survival and duration of response [1].

MvasiCancer in adults, including breast, cervical, colorectal, non-small cell lung, ovary and kidney cancers

Information

Mvasi
Biosimilar
Amgen
Amgen

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Launched
Oct 20Amgen is planning UK launch [15].
Jun 20Company cannot confirm the date of availability of ABP215 in the UK [14].
Jan 19Has been available in the US since Oct 17 [13].
Jan 18Approved for the treatment of various cancers, combined with other agents: metastatic carcinoma of the colon, rectum, breast; unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC); advanced/metastatic renal cell cancer; epithelial ovarian, fallopian tube, or primary peritoneal cancer; metastatic carcinoma of the cervix [12].
Nov 17Amgen also submitted an MAA for a bevacizumab biosimilar called Kyomarc but withdrew the application. Based on the review of the data at the time of the withdrawal, the CHMP had no major concerns and was of the provisional opinion that Kyomarc could have been approved for the treatment of the cancers listed above - see EMA questions and answers [11].
Nov 17CHMP recommends EU approval for various cancer indications [11].
Sep 17Approved in US [10].
Aug 17Patent expiry including paediatric extension 06/20 [9].
Jul 17FDA’s Oncologic Drugs Advisory Committee voted 17-0 to recommend approval of ABP 215 in each of the approved indications [8].
Dec 16Marketing Authorisation Application submitted to the EMA, based on non-clinical data plus the results of the PIII clinical trial. Amgen-Allergan believe that this will be the first bevacizumab biosimilar application submitted to the EMA [7].
Nov 16Filed in US. Amgen-Allergan based the application in part on a PIII study of patients with non-squamous NSCLC [6].
Nov 15Reference product primary conditions are colorectal cancer, non-squamous NSCLC, glioblastoma, RCC, breast cancer & ovarian cancer [5].
Sep 15The PIII trial reported to meet its primary outcome involved 642 patients. Amgen believes the positive NSCLC study will eventually support ABP 215´s approval in all 6 cancers for which Avastin is already indicated. But Amgen and Allergan will have to wait until Avastin´s patents run out, not expected until 2019 in the US and 2022 in Europe [4].

Category

VEGF antagonist
Varied, as multiple cancers
Cancer in adults, including breast, cervical, colorectal, non-small cell lung, ovary and kidney cancers
Intravenous infusion

Trial or other data

Sep 15Trial results announced. The PIII trial of biosimilar ABP-215 hit primary and secondary endpoints, showing clinical equivalence in the objective response rate and comparable safety to Avastin [3]
Sep 15Final data collection date for primary outcome measure was July 2015 [2]
Feb 14NCT01966003 is a randomized, double-blind, PIII study of ABP 215 vs bevacizumab in 620 subjects with advanced NSCLC. The primary outcome is objective response rate (ORR) up to 19 weeks. The study started Oct 13 and is due to complete Feb 16 [1]

Evidence based evaluations

Abevmy (UK), Lextemy (EU)Cancer in adults, including breast, cervical, colorectal, non-small cell lung, ovary and kidney cancers

Information

Abevmy (UK), Lextemy (EU)
Biosimilar
Mylan UK
Viatris

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
Pre-registration (Filed)
Aug 21Approved in UK with same indications as in the EU [8].
Feb 21Biocon Biologics reports that following adoption of positive opinion by the CHMP for bevacizumab biosimilar (Abevmy), for approval in the UK, the EC decision reliance procedure (ECDRP) will be followed, whereby, the MHRA may rely on a decision taken by the European Commission (EC) on the approval of bevacizumab biosimilar and the decision of approval will be followed shortly after the EC decision [6].
Feb 21The proposed indications for Abevmy/Lextemy are treatment of adults with metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer, advanced and/or metastatic renal cell cancer, persistent, recurrent, or metastatic carcinoma of the cervix , and epithelial ovarian, fallopian tube, or primary peritoneal cancer [5].
Feb 21Recommended for EU approval by CHMP - approval covers all indications of the originator product [5].
May 20Preregistration for Non-small cell lung cancer (Combination therapy, First-line therapy, Inoperable or Unresectable, Late-stage disease, Metastatic disease, Recurrent) in European Union (IV) before May 2020 [3].
Mar 20Mylan announced on 27 February 2020 that the US Food and Drug Administration (FDA) has accepted its application for its bevacizumab biosimilar (MYL 1402O) [1].

Category

Inhibitor of vascular endothelial growth factor A (VEGF-A)
UK incidence of advanced NSCLC is 40 per 100,000 people; 25% are able to have first-line therapy, of these 20-40% may receive second-line therapy.
Cancer in adults, including breast, cervical, colorectal, non-small cell lung, ovary and kidney cancers
Intravenous infusion

Trial or other data

Mar 20PIII multicenter double-blind, randomized, study to assess the efficacy and safety of MYL-1402O compared with Avastin®, in the first-line treatment of patients with stage IV Non-small cell lung cancer [2]

Alymsys (Zentiva) / Oyavas (Genus) Cancer in adults, including breast, cervical, colorectal, non-small cell lung, ovary and kidney cancers

Information

Alymsys (Zentiva) / Oyavas (Genus)
Biosimilar
Zentiva Pharma / Genus
Not Known

Development and Regulatory status

Launched
Approved (Licensed)
Approved (Licensed)
June 2021
Apr 22 Amneal Pharmaceuticals announce that the FDA has approved the BLA for for bevacizumab-maly, a biosimilar referencing Avastin®. The product will be marketed under the proprietary name ALYMSYS and indicated for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma in adults, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer and epithelial ovarian, fallopian tube, or primary peritoneal cancer [9]
Nov 21Oyavas 25mg/ml concentrate for solution for infusion launched in the UK. Price of 100mg/4ml, 1 vial =£230.00 and 400mg/16ml, 1 vial =£877.80 [8].
Sep 21Genus Pharmaceuticals will be marketing MB02 as Oyavas 25 mg/mL concentrate for solution for infusion (4 and 16ml vials) in the UK [7].
Jun 21Alymsys 25mg/ml concentrate for solution for infusion launched in the UK. Price of 100mg/4ml, 1 vial =£205.55 and 400mg/16ml, 1 vial =£810.10 [6].
May 21Licensed in UK [5].
Mar 21Approved in EU [4].
Jan 21Oyavas (and Almysys) are intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix [3].
Jan 21Recommended for EU approval by CHMP - approval covers all indications of the originator product. Mabxcience have also received a positive opinion with the brand name Alymsys [3].
Sep 20Stada have in-licensed bevaccizumab biosimilar developed by Mabxience, a Spanish company and Thornton & Ross have the rights to promote it in the UK under the brand name Oyavas [2].
Sep 20PIII equivalence trial with Avastin completed Feb 20 [1].
Aug 20Currently pre-registration in EU [2].

Category

Vascular endothelial growth factor (VEGF) inhibitor
UK incidence of advanced NSCLC is 40 per 100,000 people; 25% are able to have first-line therapy, of these 20-40% may receive second-line therapy.
Cancer in adults, including breast, cervical, colorectal, non-small cell lung, ovary and kidney cancers
Intravenous infusion

Trial or other data

Sep 20PIII multinational equivalence trial to compare the efficacy and safety of MB02 plus chemotherapy (carboplatin and paclitaxel) versus Avastin® plus chemotherapy (carboplatin and paclitaxel) in subjects with Stage IIIB/IV non-squamous NSCLC (NCT03296163) has completed [1].

Evidence based evaluations

VegzelmaCancer in adults, including breast, cervical, colorectal, non-small cell lung, ovary and kidney cancers

Information

Vegzelma
Biosimilar
Celltrion
Celltrion

Development and Regulatory status

None
Pre-registration (Filed)
Pre-registration (Filed)
Oct 21Celltrion announced that it had submitted applications for approval of CT P16 with the US Food and Drug Administration (FDA) [5].
Oct 21Celltrion announced that it had completed the application procedure for CT P16 with the European Medicines Agency (EMA). The company plans to obtain approval for all indications covered by the originator product, Roche’s Avastin (bevacizumab), including metastatic colorectal cancer and non-small cell lung cancer [5].

Category

VEGF antagonist
Colorectal cancer is the third most common cancer in the UK after breast and lung cancer, with approximately 40,000 new cases registered each year.
Cancer in adults, including breast, cervical, colorectal, non-small cell lung, ovary and kidney cancers
Intravenous infusion

Trial or other data

May 21No results posted yet for PIII (NCT3676192) trial [4]
Oct 20 PIII trial (NCT3676192) comparing CT-P16 with Avastin in terms of efficacy determined by overall response rate (ORR) completes recruitment. 690 adults were recruited only in Korea [4].
May 20 PIII trial (NCT3676192) estimated primary completion still Jan 2021 [3]
Jul 19PIII trial to Compare Efficacy and Safety of CT-P16 and EU-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer (NCT03676192) due to complete Aug 2023 (primary completion Jan 2021)[2].
Aug 18 Celltrion initiates Phase 3 clinical trial for CT-P16 in about 150 sites in some 20 nations across Europe, Asia and South America (no further details available) [1].

Information

Lytenava
New formulation
Outlook Therapeutics
Outlook Therapeutics

Development and Regulatory status

None
None
Pre-registration (Filed)
Apr 22Outlook therapeutics announces it has submitted its its Biologics License Application (BLA) to the FDA for ONS-5010 for the treatment of wet AMD [21].
Feb 22If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialise it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan and other markets [22].
Dec 21Update from Outlook Therapeutics confirms that, with the registration clinical trials now completed, they intend to submit a BLA to the FDA Q1 2022 with approval anticipated Q1 2023. The company is also developing registration documents on a parallel path for approvals in Europe and expects to submit them shortly after completing the FDA submission. If approved, trials are also planned to investigate use of ONS-5010 in branch retinal vein occlusion and diabetic macular oedema. Outlook also plan to file a supplementary application for approval of the product in a pre-filled, silicone-free syringe, with a trial (NORSE SEVEN) planned to compare the safety of ONS-5010 in vials vs syringes [18].
Jun 21Topline readout of data from PIII NORSE-2 study targeted for calendar Q3 21, and company plans to file a new Biologics License Application (BLA) filing to the FDA Q1 22. Registration documents are also being completed in parallel for approvals in Europe to be submitted shortly after completing the US filing. While Outlook Therapeutics continues to target potential strategic commercialisation partners, particularly for European markets, it is preparing to launch ONS-5010 in the United States by itself, pending FDA approval [17].
Jan 21Outlook Therapeutics announces intention to submit MAA to European Medicines Agency for Retinal disorders in 2021 and commercial launch in 2022 [14].
Dec 20Outlook is in active late-stage discussions for the licensing and/or co-development rights to ONS-5010, but could potentially market it. In the US it believes that ONS-5010 will be entitled to 12 years regulatory exclusivity against biosimilar competition. Despite widespread acceptance and use of bevacizumab to treat ophthalmic diseases such as wet AMD, DME and BRVO, no manufacturer has previously sought approval from FDA or EMA. Products provided off-label by compounding pharmacies can carry known risks of contamination (including silicone oil droplet contamination from syringes) and inconsistent potency, with potentially severe consequences, as leading retinal societies have reported. If ONS-5010 is approved and commercialised, Outlook expects it will be priced responsibly compared to other branded anti-VEGF therapies to help mitigate the high cost of treatment for retinal diseases [16].
Aug 20Based on end-of-Phase 2 discussions with the FDA, Outlook believes that the results from NORSE 1 and NORSE 2, combined with our upcoming NORSE 3 safety study that is designed to ensure an adequate number of patient exposures to ONS-501, will be sufficient to support a new BLA submission in H2 2021 [12].
Aug 20Outlook Therapeutics intends to complete development of ONS-5010 for submission to the FDA as a new BLA under the 351(a) PHSA regulatory pathway for the treatment of wet AMD and also has plans to submit for regulatory approvals in Europe, the UK and Japan, as well as other countries [12].
Jun 20Company is also planning to file in the US for wAMD and other retinal diseases in 2021 [10].
Jun 20Outlook currently intends to commercialize ONS-5010 in both vials and single-use pre-filled syringes [5].
Sep 19Outlook therapeutics plan to submit ONS-5010 for regulatory approval in multiple markets in 2020 [4].
Apr 19the company plan to submit ONS-5010 for regulatory approval in multiple markets in 2020 [3].
Nov 18Oncobiologics is developing ONS-5010 as an innovative therapy and not using the biosimilar drug development pathway [1].

Category

Vascular endothelial growth factor (VEGF) inhibitor
The estimated prevalence of AMD in the UK is 4.8% of those over 65 years of age and 12.2% of those aged 80 years or more. There are around 70,000 new diagnoses in the UK each year [2].
Wet age-related macular degeneration (AMD) - ophthalmic formulation
Intravitreal

Trial or other data

Dec 21Annual update from Outlook reports all three registration trials (NORSE-1, NORSE-2 and NORSE-3) have now completed and data presented at scientific conferences. In NORSE-2, ONS-5010 achieved statistically significant and clinically relevant primary (p = 0.0052) and key secondary (p = 0.0043) efficacy endpoints with 41.7% of subjects gaining at least 15 letters of BVCA. Safety data from NORSE-3 showed no unanticipated safety signals, with no intraocular inflammation or vasculitis, and the frequency and incidence of adverse events and ocular adverse events low. The most common adverse event in the study eye was conjunctival haemorrhage related to injection procedure, not to ONS-5010, and there were no additional serious adverse events associated with these injections. A further open-label trial (NORSE-7; NCT05112861) is also planned in the US to compare the safety of ONS-5010 in vials vs pre-filled syringes in subjects (n=120) with visual impairment due to retinal disorders including exudative AMD, diabetic macular oedema, or branch retinal vein occlusion. Estimated primary completion date is Dec 2022 [18-20].
Jun 21Outlook completes patient dosing in the pivotal PIII NORSE-2 trial [17].
May 21PIII NORSE-1 study is recruiting in Australia; PIII NORSE-2 and NORSE-3 are recruiting in the US [15].
Sep 20PIII NORSE-2 study (NCT03834753) is now due to complete collection of primary outcome data in Jun 2021. PIII NORSE-3 study (NCT04516278) is a 3-month study that will evaluate the safety of ophthalmic bevacizumab in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion. 180 adults will be recruited and data collection is expected to complete Mar 21 [13].
Aug 20Outlook Therapeutics expects to report pivotal safety and efficacy data from NORSE 2 in Q3 2021 [12].
Aug 20Top-line results announced demonstrating safety and efficacy of ONS-5010 for the treatment of wet AMD from the NORSE-1 clinical study. Overall, 2 of 25 (8%) patients on ONS-5010 achieved > 15 letters best corrected visual acuity (BCVA) at Month 11 compared to 5 of 23 (22%) patients on the ranibizumab arm, with no statistical differences between ranibizumab and ONS-5010. The results from NORSE 1 met our proof-of-concept expectations and, importantly, validate our confidence in the design of our ongoing NORSE 2 trial [12].
Jun 20PIII trial NORSE-1 (NCT03844074) due to complete August 2020, and NORSE 2 (NCT03834753) due to complete Dec 20 [6].
Sep 19PIII trial NORSE-1 has completed patient recruitment, this is evaluating ONS-5010 against ranibizumab (Lucentis®) for wet AMD [4].
Apr 19ONS-5010-002 is the second PIII clinical trialsevaluating ONS-5010 against ranibizumab (Lucentis®) for wet AMD and will enroll approximately 180 patients (90 in each arm). Patients will be treated for 11 months, the primary outcome is a statistically significant improvement in mean visual acuity of five letters or more for ONS-5010 over ranibizumab [3].
Nov 18Oncobiologics has begun dosing patients in its first clinical trial for ONS-5010 in patients with wet age related macular degeneration (wet AMD) [1].

bevacizumab biosimilar (BAT1706)Cancer, including non-small cell lung cancer

Information

bevacizumab biosimilar (BAT1706)
Biosimilar
Bio-Thera
Bio-Thera

Development and Regulatory status

None
Pre-registration (Filed)
Pre-registration (Filed)
Jun 21UK launch uncertain at this time it seems unlikely Bio-Thera will market it themselves in the UK, and no marketing partner for the UK has been announced [8].
May 21Bio-Thera has several licensing agreements in place to allow other companies to market BAT1706 - Cipla in select emerging markets, Biomm in Brazil and BioGene in China, Hong Kong, Macau and Taiwan [6].
Jan 21The FDA has accepted a Biologics License Application (BLA) for BAT1706 [5].
Nov 20Biothera has submitted the MAA for BAT1706, a bevacizumab biosimilar to the EMA [4].
Jun 20Filed with Chinese NMPA [3].
Feb 20Bio-Thera intends to file for regulatory approval for BAT-1706 with the China National Medical Products Administration (NMPA), the European Medicines Agency and the US Food and Drug Administration in 2020 [2].

Category

VEGF-A inhibitor that can slow the growth of new blood vessels in tumours
UK incidence of advanced NSCLC is 40 per 100,000 people; 25% are able to have first-line therapy, of these 20-40% may receive second-line therapy.
Cancer, including non-small cell lung cancer
Intravenous infusion

Trial or other data

May 21PIII trial (NCT03329911) recruited only in China [7].
Feb 20PIII trial comparing the safety and efficacy of BAT1706 versus the originator biological Avastin (bevacizumab) met its primary endpoint of comparability with originator product [2].
Oct 17PIII trial NCT03329911 starts of BAT1706 Versus EU Avastin Plus Chemotherapy in Patients With Advanced Non Squamous Non Small Cell Lung Cancer, estimated completion March 2020 [1].

EquidacentCancer, including colon, rectum, breast, renal and non-small cell lung cancer

Information

Equidacent
Biosimilar
Centus Biotherapeutics
Centus Biotherapeutics

Development and Regulatory status

Licensed but not launched
Licensed but not launched
None
Nov 20Plans for UK launch not decided [8].
Sep 20The EC has granted the marketing authorization for FKB238, bevacizumab biosimilar [7].
Jul 20Recommended for EU approval by CHMP - approval covers all indications of the originator product [6].
Nov 19Currently pre-registration in the EU [5].

Category

Vascular endothelial growth factor-A (VEGF-A) inhibitor
Colorectal cancer is the third most common cancer in the UK after breast and lung cancer, with approximately 40,000 new cases registered each year.
Cancer, including colon, rectum, breast, renal and non-small cell lung cancer
Intravenous infusion

Trial or other data

Dec 18PIII trial Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer (AVANA; NCT02810457) active not recruiting [4].
Jun 16PIII trial started comparing FKB-238 with originator bevacizumab Avastin in patients with advanced/recurrent non squamous non-small cell lung cancer (NCT02810457), estimated primary completion date Jun 2019 [2].
Nov 14PI trial started in Europe [1].

Information

Ipique
Biosimilar
Rotterdam Biologics
Rotterdam Biologics

Development and Regulatory status

None
Not recommended for approval (Negative opinion)
None
Feb 22After re-examining its initial opinion, the EMA has confirmed its recommendation to refuse marketing authorisation for the medicine Ipique [5].
Jan 22Company have requested a re-examination of EMA’s November 2021 opinion. Upon receipt of the grounds of the request, the Agency will re-examine its opinion and issue a final recommendation [4].
Nov 21EMA CHMP recommends refusal of the MAA for Ipique as the literature review submitted by the company was only based on data obtained with other bevacizumab-containing medicines and that no evidence had been submitted comparing Ipique with another bevacizumab medicine when used intravitreally [1].
Jun 20Filed in the EU [3].

Category

A humanised biosimilar of bevacizumab, acts as a vascular endothelial growth factor (VEGF) antagonist, which inhibits VEGF A-induced signalling and partially inhibits VEGF-driven angiogenesis.
The estimated prevalence of AMD in the UK is 2.4% in those over 50 years of age, 4.8% of those over 65 years of age and 12.2% of those aged 80 years or more. Primary diagnoses of AMD in English hospitals have increased from fewer than 10,000 episodes in 2005/06 to in excess of 75,000 in 2013/14 [2].
Neovascular (wet) age-related macular degeneration (AMD) - ophthalmic formulation
Intravitreal