Coherus and partner Junshi will resubmit the BLA for toripalimab by mid-summer after the US FDA requested a quality process change.

Coherus BioSciences announced this week itself and partner Junshi Biosciences received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its metastatic nasopharyngeal carcinoma (NPC) candidate toripalimab.

Toripalimab was first approved in China to treat melanoma in 2018, but Coherus acquired the North American right to the anti-PD-1 antibody in February 2021 through a $150 million deal with Shanghai, China-based Junshi.

The letter “requests a quality process change that we believe is straightforward and readily addressable,” Theresa LaVallee, Coherus CDO said during her firm’s Q1 earnings call yesterday. “We plan to meet with the FDA to ensure our resubmission is complete and will submit the request package in the next few days. We plan to resubmit BLA by mid-summer 2022.”

She continued: “The agency also communicated in the CRL that the review timeline for the BLA resubmission would be six months, as required on-site inspections have been hindered by travel restrictions related to the COVID-19 pandemic in China. The FDA has indicated that the existing toripalimab clinical data are supportive of the BLA submission.”

While the firms did not reveal where toripalimab is manufactured, Junshi has its own manufacturing capabilities in Suxhou/Shanghai. The firm also has an ongoing collaboration with Lonza, with the Swiss contract development and manufacturing organization (CDMO) producing an undisclosed monoclonal antibody from its Guangzhou, China facility.

Coherus has some experience with CRLs. In 2017, the FDA requested a reanalysis of a subset of subject samples, along with additional manufacturing related process information, for its biosimilar version of Amgen’s Neulasta (pegfilgrastim). The molecule won approval 18 months later and is marketed in the US under the brand name Udenyca.