Cinfa Biotech is banking on extensive scientific advice from regulators in the EU to ease the path to approval for its biosimilar version of Amgen’s blockbuster drug Neulasta (pegfilgrastim) for treating chemotherapy-induced neutropenia.
The Spanish company filed a marketing authorization application (MAA) for its lead product candidate, B12019, with the European Medicines Agency last month. Cinfa Biotech is attempting to break into a...