Daiichi Sankyo Ends Development of Biosimilar to Amgen’s Enbrel for Manufacturing Issues

Daiichi Sankyo has decided to discontinue the development in Japan of CHS-0214, an investigational etanercept biosimilar in rheumatoid arthritis to Amgen’s Enbrel (etanercept), in partnerships with Coherus BioSciences, a Redwood City, California-based biosimilar developer. Amgen’s Enbrel is the company’s top-selling drug with 2016 global sales of $5.965 billion.

Daiichi Sankyo said that a commercial manufacturing process to enable the feasible supply of CHS-0214 in Japan cannot be established at this time.

The company noted, however, that the primary endpoint, evaluating the disease activity of rheumatoid arthritis after the administration of CHS-0214, met the criteria of equivalence as defined in advance in CHS-0214 and reference product groups and achieved the intended purpose.

This is another setback for Coherus relating to a biosimilar. In June 2017, the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the company’s biologics license application (BLA) for CHS-1701, a pegfilgrastim biosimilar candidate to Amgen’s Neulasta. The CRL primarily focused on the FDA request for a reanalysis of a subset of subject samples with a revised immunogenicity assay and requests for certain additional manufacturing-related process information.

Pfizer also reported in June 2017 that it had received a CRL from the FDA regarding its BLA for its proposed epoetin alfa biosimilar over manufacturing issues.

Source: Daiichi Sankyo

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