Hanwha Chemical Corporation, through its Bio Business Unit, and Merck, through a subsidiary, will work together to develop and commercialize HD203, a candidate biosimilar form of etanercept developed by Hanwha. Merck will conduct clinical development and be responsible for manufacturing. In addition, upon marketing approval, Merck will commercialize HD203 globally, except for in Korea and Turkey where Hanwha has retained marketing rights. In return, Hanwha receives an upfront payment from Merck and will be eligible for additional payments associated with milestones for technology transfer and regulatory progress as well as tiered royalties on sales. Specific financial terms of the agreement were not disclosed.
The PR does not say whether MRK intends to seek US approval via a conventional BLA or via the new 351(k) pathway for FoB’s. Enbrel had 2010 worldwide sales of $7.2B, of which about half was in the US (#msg-59851976).
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