Coherus Terminates 30% of Its Workforce After FDA's Complete Response Letter

Just 2 weeks after Coherus BioSciences announced that it had received a complete response letter (CRL) from the FDA in response to its biologics license application for a pegfilgrastim biosimilar candidate, the company has laid off 51 employees, or approximately 30% of its workforce, in a bid to cut its operating costs by $10 million. Coherus disclosed its restructuring plan to the Securities and Exchange Commission, citing the need to “better align its workforce with the needs of its business” following the CRL.

The California-based drug company had hoped to challenge Amgen—maker of the biosimilar’s reference product, Neulasta—in the lucrative oncology marketplace. Coherus had called Neulasta the largest-selling oncology biologic in the United States, and the CRL for Coherus proved a serious blow to the drug maker’s financial outlook.

News of the company’s layoffs arrived less than 2 months after Coherus reported disappointing earnings for its first quarter after it ended its agreement with Shire over a proposed etanercept biosimilar, known as CHS-0214, for the European market and other territories. In terminating its relationship with Shire, Coherus regained development and commercial rights to CHS-0214.

In the months ahead, Coherus will attempt to put its pegfilgrastim program back on track by addressing the FDA’s concerns about the biosimilar candidate. The company plans to reanalyze a subset of samples with a revised immunogenicity assay and provide further information about its manufacturing process.

While it contends with these challenges with its now leaner workforce, Coherus sees potential good news on the horizon; in May and June, the Patent Trial and Appeal Board (PTAB) ruled in favor of 3 Coherus petitions for inter partes review of core AbbVie patents on the blockbuster drug adalimumab (Humira). PTAB’s rulings clear the way for Coherus to advance its plans for an adalimumab biosimilar that could capture some market share from the world’s top-selling drug.