The product has the brand name, Benpali, and is approved for all of Enbrel’s EU indications (RA, psoriatic arthritis, axial spondyloarthritis, and plaque psoriasis).
The EU Commission action was a fait accompli following CHMP approval in Nov 2015 (#msg-118656882). Under the terms of the Samsung’s FoB partnership with BIIB and MRK (#msg-118427495), BIIB will have Benpali marketing rights in the EU. The same drug is approved in South Korea, where MRK has the marketing rights and the brand name is Brenzys (#msg-116805547).
In the US, Samsung has not (publicly) pursued an Enbrel-FoB program (see link at the bottom of #msg-118427495), which is presumably due to AMGN’s US patent that runs until 2028 (#msg-69263618). However, NVS thinks AMGN’s US Enbrel patent can be overcome (#msg-117422298), so the possibility of Enbrel FoBs in the US market should not be dismissed entirely.
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