Coherus Seeks Stay in BPCIA Litigation, Cites "Preservation of Resources"

Coherus BioSciences has moved for a stay of discovery in Biologics Price Competition and Innovation Act (BPCIA) litigation concerning its proposed pegfilgrastim biosimilar, CHS-1701, referenced on Amgen’s blockbuster drug Neulasta.

In the motion filed last week, Coherus told the court that it believes the recent regulatory delay of CHS-1701 justifies a stay in litigation; in June, the company received a complete response letter (CRL) from the FDA with respect to the biosimilar product. The agency asked Coherus to reanalyze a subset of samples with a revised immunogenicity assay. It also requested that the drug maker provide additional manufacturing-related process information, though it did not request a clinical study of CHS-1701 in oncology patients or indicate that additional process qualification lots would be needed.

On the heels of the CRL and the subsequent delay of the product, Coherus terminated approximately 30% of its workforce, or 51 employees, in an attempt to cut its operational costs by $10 million. Coherus suffered another setback when Daiichi Sankyo, the company’s partner in the development of an investigational etanercept biosimilar, CHS-0214, terminated its relationship with the biosimilar maker.

In light of its new financial outlook, Coherus told the court in its motion for a stay that “Preservation of resources is especially important to Coherus—a new start-up biosimilar company that has no products and, because of a recent FDA rejection of its drug application, will have no revenue until its anticipated mid-2018 launch of the product at issue in this case,” and claimed that “Amgen can use its vast resources to bankrupt Coherus with unnecessary litigation expenses before Coherus can launch [CHS-1701].”

The ongoing BPCIA litigation began when the California-based biosimilar developer filed a Biologics License Application for its biosimilar product in October 2016, initiating an information exchange process, or the so-called “patent dance,” with Amgen. Subsequently, Amgen filed its initial complaint in May 2017, claiming that Coherus had infringed on one of its patents—Coherus then moved to dismiss Amgen’s complaint.

Coherus claims that discovery in the case should not proceed while its motion to dismiss is pending before the court.

The court has ordered the parties to comply with a July 18 order to submit case management documents to court by August 17, 2017. After it receives the required documents, the court will hear oral arguments on Coherus’ motion to stay litigation.