Coherus BioSciences announced the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a positive opinion for the marketing authorization of UDENYCA, a Neulasta biosimilar candidate. “UDENYCA has the opportunity to become one of the first pegfilgrastim biosimilars to gain Marketing Authorization in Europe. The positive opinion issued by the CHMP today is a significant milestone for Coherus, as it validates both our UDENYCA biosimilarity package as well as our development platform as a whole. We believe UDENYCA will represent an important option for patients, providers and payers seeking alternatives for the treatment and prevention of febrile neutropenia due to cytotoxic chemotherapy in Europe,” the company stated.
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