Samsung beats pharma to develop first EU-approved Enbrel biosimilar
pharmafile | January 18, 2016 | News story | Manufacturing and Production | Benepali, CHMP, EMA, Enbrel, Samsung, Samsung Bioepis, etanercept, positive opinion
Samsung Bioepis – the collaboration between Samsung Biologics and Biogen Idec, has become the first company to have a biosimilar version of Enbrel approved by the EMA.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, meaning a European Commission (EC) approval for Benepali, a copycat version of Enbrel (etanercept) is likely.
It is recommended for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis, and marks the first time the CHMP has adopted a positive opinion on an etanercept biosimilar. If a marketing authorisation is granted by the EC, Benepali will be the first etanercept biosimilar to be approved in the European Union.
To earn the positive opinion, Samsung Bioepis had to demonstrate that the biosimilar has the same chemical quality, efficacy and safety as the reference product. In November, positive results from a one-year Phase III study, presented at the American College of Rheumatology conference its version of etanercept sustained comparable safety profiles.
The 52-week SB4 study, which randomised 596 patients in 10 countries, showed a 20% improvement (ACR20 response) rate of 80.8% in patients who took the biosimilar, compared to 81.5% in the Enbrel arm. An earlier analysis of results after 24-week study results found rates of 78.1% and 80.3%, respectively.
“The approval of Benepali and its subsequent launches in Europe are major milestones for Samsung Bioepis,” said Christopher Hansung Ko, president and chief executive of Samsung Bioepis. “In just under four years, we successfully developed, tested and obtained regulatory approval for Benepali, a high-quality biologic medicine that will drive down healthcare costs and increase patient access to one of the most widely used treatment options for immunological diseases across Europe.”
In addition to Benepali, Samsung Bioepis has been developing two other anti-tumour necrosis factor-alpha (anti-TNF-alpha) investigational biosimilar candidates: SB2 investigational biosimilar candidate to Remicade (infliximab), and SB5 investigational biosimilar candidate to Humira (adalimumab).
Lilian Anekwe
Related Content
CHMP recommends Novo Nordisk’s Awiqli for diabetes treatment
Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for …
EC approves Pfizer’s Prevenar 20 to protect paediatric patients against pneumococcal disease
Pfizer has announced that the European Commission (EC) has granted marketing authorisation for Prevenar 20, …
EMA validates two applications for datopotamab deruxtecan for cancer treatments
AstraZeneca has announced that the European Medicines Agency (EMA) has validated to marketing authorisation applications …
