SINGAPORE--The Marketing Authorization Application for SB4, the Enbrel (etanercept) biosimilar candidate developed by Korean biopharmaceutical company Samsung Bioepis, has been accepted for review by the European Medicines Agency (EMA). It will become the first Enbrel biosimilar subjected to regulatory review in the European Union.
Enbrel is currently used for treating a number of rheumatic diseases in Europe. Once SB4 is authorized by the EMA, it could be available in all the same indications as Enbrel, including moderate to severe RA, certain forms of juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis.
"This MAA validation represents a significant milestone for Samsung Bioepis in our work to develop and manufacture world-class biosimilars. More significantly, it offers an opportunity to provide high-quality and effective therapies for broadening access to patients in Europe," said Christopher Hansung Ko, the CEO of Samsung Bioepis.
The patents on Enbrel in Europe are expected to expire in February 2015, making the authorization of SB4 a very well-timed happening. The originator product, Amgen's Enbrel, had sales of US$8.8 billion in 2013, making it a top selling biologicals and a worthwhile target for biosimilar developers.
The marketing authorization application (MAA) of SB4 was based on results from a Phase III clinical trial in patients with moderate-to-severe rheumatoid arthritis (RA). If SB4 is authorized by the EMA, it will be commercialized in Europe by Biogen Idec.
Biogen Idec expanded its partnership with Samsung Bioepis in 2013 to sell biosimilars in the EU, where a strong market for biosimilars exists with a clear regulatory pathway.
SB4 will be produced at Biogen Idec's manufacturing facility in Denmark, which is one of the biggest biologic manufacturing facilities in the world.
Samsung Bioepis expressed intentions to continue moving forward with additional applications for regulatory approvals in other territories worldwide, aiming to become a world leader with its background in innovative and advanced technologies.
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