Samsung Bioepis's Enbrel biosimilar candidate up for EMA review

MARKING the first Enbrel biosimilar to advance into regulatory review in the European Union, Samsung Bioepis Co. Ltd’s Marketing Authorization Application (MAA) for its SB4 Enbrel (etanercept) biosimilar candidate has been validated and accepted for review by the European Medicines Agency (EMA). 

 

The MAA was based on the results of a Phase 3 clinical trial involving patients with moderate to severe rheumatoid arthritis (RA). The controlled, randomized, multicenter study in Europe demonstrated SB4 is comparable to Enbrel. An assessment of the primary and secondary endpoints of the study indicated they met the qualification standard for the MAA submission. The study’s full data will be available later this year.

 

Enbrel is indicated in Europe for the treatment of several rheumatic diseases, including moderate to severe RA, certain forms of juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. 

 

SB4 could be available for use in all of the same indications as Enbrel once it obtains EMA approval. It will be marketed in Europe by Biogen Idec, which will also handle production in its manufacturing facility in Hillerød, Denmark, one of the largest biologic manufacturing facilities globally.

 

According to Samsung Bioepis chief executive officer Christopher Hansung Ko, "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." 

 

Samsung Bioepis plans to file additional applications for regulatory approvals for the SB4 in other territories worldwide.