In latest setback, another Coherus partner bails out on Amgen biosimilar deal

Just days after Coherus $CHRS was forced to restructure and lay off 51 staffers in the wake of the FDA’s decision to reject its application for a biosimilar of Amgen’s Neulasta, its Japanese partner on the number-two program in the pipeline is bailing out of their collaboration.

Daiichi Sankyo says that their Phase III program for CHS-0214 hit the endpoint on equivalency with Enbrel in treating rheumatoid arthritis. But:

(D)ue to the fact that a commercial manufacturing process to enable the feasible supply of CHS-0214 in Japan cannot be established at this time, Daiichi Sankyo has decided to discontinue the development of CHS-0214 in Japan.

Shire $SHPG punted back rights to the same knockoff program last fall, handing the program to Coherus after determining that the therapy — bagged in the Baxalta buyout — didn’t fit into their plans for the future.

Daiichi Sankyo signed up to partner with Coherus five years ago and had been in the hunt for a 2017 approval.

According to Coherus, the FDA had requested more sample analysis before they would reconsider their marketing application for the Neulasta generic, which was looking to carve into a $4 billion annual franchise. Novartis won an approval for their biosimilar of Enbrel, an even bigger drug at Amgen worth $9 billion, a year ago. But Amgen has been fighting back in court, delaying any marketing move. And Samsung Bioepis scored an EU approval for an Enbrel biosimilar in early 2016.

Ironically, Daiichi Sankyo also struck a deal to market Amgen’s $AMGN biosimilars in development.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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