According to Daiichi Sankyo, a lack of commercial manufacturing process informed the decision.
“The commercial manufacturing process for stable supply was not established,” a Daiichi Sankyo spokesperson told Biopharma-Reporter.
“We are not commenting on any additional details, as the manufacturing process or technical platform is proprietary,” we were told.
The FDA’s complete response letter (CRL) regarding Coherus’ Biosimilar License Application (BLA), issued on June 12, said the firm needs to reanalyse patient data. The agency also requested additional manufacturing information.
Coherus said it intended to work with the FDA in order to address the information requests.
The Daiichi Sankyo spokesperson told us the FDA rejection did not affect the firm’s decision to stop making the drug.