Etanercept
Articles · Refrigerated Storage · Lactation Safety Information · New Medicines · Published , updated
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Articles
28th September 2017
Discussion sheets from first wave of Regional Medicines Optimisation Committee meetings
Four Regional Medicines Optimisation Committees exist for England, with one sited in each of the NHS England regional geographies (The North, Midlands and the East,… Adalimumab Cancers Etanercept Gastrointestinal disorders Infection and infectious diseases Infliximab Musculo-skeletal disorders News Policy, Commissioning and Managerial Policy, Guidance, and Standards Polypharmacy Rituximab RMOC medicines optimisation recommendations and resources Trastuzumab Usage
12th September 2017
NHS England commissioning framework for biosimiliar medicines
NHS England has published a commissioning framework for biosimilar medicines. The purpose of this document is to support commissioners to act promptly to make the… Adalimumab Etanercept Infliximab New Medicines News Rituximab Trastuzumab
23rd March 2016
In use Product Safety Assessment report for Benepali® (etanercept biosimilar)
A UKMi Product Safety assessment on etanercept biosimilar (Benepali®) which describes the in-use medication safety considerations resultant from the product’s presentation or other pre-defined characteristics.… Etanercept Gastrointestinal disorders Medicines Safety Musculo-skeletal disorders System Safety
4th March 2016
Answers to commonly asked questions about biosimilar versions of etanercept
The first biosimilar version of etanercept (Benepali®) was approved for use in Europe in November 2015 and is due to be launched in the UK… Acute Care Etanercept Musculo-skeletal disorders Skin disorders
20th May 2012
Safety in Lactation: Drugs which suppress the rheumatic disease process
Disease-modifying anti-rheumatic drugs (DMARDs) have a varied pharmacology, mainly either modifying the immune response to the disease or modifying the disease process. The choice of… Abatacept Adalimumab Anakinra Azathioprine Belimumab Certolizumab pegol Chloroquine Ciclosporin Etanercept Golimumab Hydroxychloroquine Infliximab Leflunomide Methotrexate Penicillamine Rituximab Sodium aurothiomalate Sulfasalazine Tocilizumab Ustekinumab
20th May 2012
Safety in Lactation: Systemic preparations for eczema and psoriasis
Drugs used orally or parenterally for severe eczema and psoriasis have a varied pharmacology, mainly either modifying the immune response to the disease or modifying… Acitretin Adalimumab Alitretinoin Azathioprine Ciclosporin Etanercept Infliximab Methotrexate UstekinumabRefrigerated Storage
Enbrel · Pfizer limited
Pfizer limited
Enbrel
Powder and solvent for solution for injection
In the event of an inadvertent temperature excursion the following data may be used:
Enbrel may be stored at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again. Enbrel should be discarded if not used within four weeks of removal from refrigeration.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
4 weeks
No
14th May 2018
London MI Service
Benepali · Biogen
Biogen
Benepali
25 mg & 50mg solution for injection in pre-filled syringe; 50 mg solution for injection in pre-filled pen.
In the event of an inadvertent temperature excursion the following data may be used:
Benepali may be stored at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again. Benepali should be discarded if not used within four weeks of removal from refrigeration.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
4 weeks
No
17th April 2019
London MI service
Lactation Safety Information
For rheumatoid arthritis
For rheumatoid arthritis
See summary
Limited published evidence of safety
Low levels anticipated in milk due to the drug’s properties and likely to be degraded in infant’s GI tract
Avoid in preterm infants and neonates as large protein molecules may appear in colostrum
16th September 2019
For psoriasis
For psoriasis
Topical psoriasis preparation / corticosteroid if appropriate
Limited published evidence of safety
Low levels anticipated in milk due to the drug’s properties and likely to be degraded in infant’s GI tract
Avoid in preterm infants and neonates as large protein molecules may appear in colostrum
16th September 2019
New Medicines
Nepexto · Rheumatoid arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, plaque psoriasis, psoriatic arthritis and spondylarthritis
Information
Nepexto
Biosimilar
Mylan
Mylan
Development and Regulatory status
Recommended for approval (Positive opinion)
Recommended for approval (Positive opinion)
Unknown
Mar 20 · Recommended for EU approval by CHMP; the recommended indications are as for the originator product - treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis [3].
Jun 18 · Lupin entered an agreement with Mylan to commercialise YLB113 [1].
May 18 · Lupin´s etanercept biosimilar was accepted for review by the EMA [1].
Category
TNF inhibitor
The incidence of rheumatoid arthritis is around 1.5 men and 3.6 women developing RA per 10,000 people per year, more women than men [2].
Rheumatoid arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, plaque psoriasis, psoriatic arthritis and spondylarthritis
Subcutaneous
etanercept biosimilar (CHS-0214) · Rheumatoid arthritis (RA)
Information
etanercept biosimilar (CHS-0214)
Biosimilar
Coherus Biosciences
Coherus Biosciences
Development and Regulatory status
Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Category
Fusion peptide consisting of two molecules of the p75 tumour necrosis factor (TNF)-α receptor linked to the Fc portion of immunoglobulin.
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)
Subcutaneous injection
etanercept biosimilar (CHS-0214) · Psoriasis
Information
etanercept biosimilar (CHS-0214)
Biosimilar
Coherus Biosciences
Coherus Biosciences
Development and Regulatory status
Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Category
Tumour necrosis factor inhibitor
Prevalence is thought to vary among ethnic groups, with a higher prevalence among Scandinavian populations. Approximately 2% of Europeans have psoriasis: plaque psoriasis is the most common type, representing 90% of cases.
Psoriasis
Subcutaneous injection