Biopartners responds to CHMP's negative opinion on Alpheon
Swiss biopharmaceuticals firm Biopartners said that it was disappointed that Alpheon, its biosimilar version of interferon alpha, had received a negative opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use. The Committee raised questions regarding the product's biosimilarity that the firm has yet to resolve. In addition, the CHMP voiced concerns about the drug's CMC (Characterization, Manufacturing and Control).
BioPartners said it would evaluate the full EMEA report in order to clarify the issues raised, with a view to resubmitting the drug to the agency.
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