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Daiichi Sankyo Parts Ways With Troubled Coherus on CHS-0214
In the wake of Coherus’ 30% reduction in workforce last week—a move that followed the company’s complete response letter from the FDA regarding its CHS-1701, a pegfilgrastim biosimilar candidate—the California-based biosimilar developer has sustained yet another blow to its business.
In the wake of Coherus’ 30% reduction in workforce last week—a move that followed the company’s complete response letter from the FDA regarding its CHS-1701, a pegfilgrastim biosimilar candidate—the California-based biosimilar developer has sustained yet another blow to its business.
Daiichi Sankyo said in a July 5 press release that it has decided to discontinue its partnership with Coherus BioSciences in the development of CHS-0214, an investigational etanercept biosimilar.
While the Tokyo-based Daiichi Sankyo said that its phase 3 trial for CHS-0214 had met its primary endpoint of determining equivalence between CHS-0214 and its reference product groups, the fact that a commercial manufacturing process to facilitate a supply of the biosimilar product in Japan could not be established had forced the company to sever its ties with Coherus on the product’s development and commercialization.
CHS-0214 was 1 of 2 biosimilars on which Daiichi Sankyo and Coherus had agreed to partner in 2012; the second product, a proposed rituximab biosimilar, appears to be unaffected by the end of the firms’ agreement on the etanercept biosimilar.
The end of the Daiichi Sankyo arrangement is the second such termination for Coherus’ CHS-0214 in the past year; Coherus regained the rights to the biosimilar candidate from Shire after the latter company’s “strategic portfolio review” in 2016.
Of the 3 biosimilar products currently in Coherus’ pipeline, only its adalimumab candidate, CHS-1420, appears to be fully on track; after an initial pharmacokinetic (PK) and bioequivalence (BE) study comparing CHS-1420 to reference adalimumab (Humira) successfully met its endpoints, Coherus initiated a phase 3 study in patients with psoriasis in 2015. Coherus incorporated a switch between the reference and CHS-1420 in the phase 3 study after receiving feedback from the FDA and EMA. The company plans to file a Biologics License Application (BLA) for the product in 2018.
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