Coherus Biosciences, known for developing biosimilars, had decided to extend its objectives in February. The company has now stepped into developing innovative medicines by purchasing partial rights to the Shanghai Junshi’s drug toripalimab, which is similar to Merck and Co.’s Keytruda and Bristol Myers Squibb’s Opdivo.
Executives have indicated that the deal is a step towards company’s transition to “Coherus 2.0” for which it has utilized its profits from the biosimilar of Amgen’s Neulasta, to aid its pipeline of experimental cancer immunotherapies. For that purpose, the said drug, which is a so-called checkpoint inhibitor, acts as a linchpin of efforts.
The drug is being tested for various tumor types including breast, lung and liver cancers, though it is already approved in China for melanoma. The biotech has targeted the drug to develop multi-drug combinations. Currently, the submission of the drug for approval in U.S. is undergoing for nasopharyngeal carcinoma.
Toripalimab’s U.S. approval may lead to a launch of cheaper checkpoint inhibitors having six-figured annual price tags. The company has not revealed its pricing strategy yet, but the analysts are expecting that it would undercut others. In February, Mizuho analyst, Salim Syed has written, “We believe … Coherus Biosciences is really going to make the PD-1 game about access and working with providers differently… in part [with] price cuts.”
A clinical-staged biotechnology firm, EQRx, is working out a similar strategy by partnering with a Chinese firm, C-Stone Pharmaceuticals, to license its own checkpoint inhibitor.
But in case of Coherus Biosciences, the drug has to be accepted by the U.S. regulatory authority for approval and in addition to that, the trials have run in china as well, for its usage for both nasopharyngeal carcinoma and lung cancer, which the Biotech wasn’t expecting. But provisioning of such a requirement is in FDA’s hands, according to Salim Syed.
The company is planning to call for a meeting with FDA in order “to discuss potential submission” with the regulatory authority, it said in a statement. Provided the toripalimab’s phase III results, the drug “seems to line up fairly well” against Keytruda, Syed wrote. But the fact how to compare the two is still unclear. Keytruda-chemotherapy combination was first approved by regulators in 2018. Lung cancer trials of Junshi’s drug were carried out afterwards. However, toripalimab-chemotherapy combination was tested against an outdated comparator for which Regeneron has already criticized, whose drug Libtayo was approved for lung cancer this year.