Posted by Michael Wonder on 24 Sep 2018
Cinfa Biotech receives positive CHMP opinion for Pelmeg (pegfilgrastim), a proposed biosimilar to Neulasta
21 September 2018 - The biosimilar company Cinfa Biotech today announced that the EMA's CHMP has issued a positive opinion recommending marketing authorization for Pelmeg (B12019), a proposed biosimilar to Neulasta (pegfilgrastim), for the treatment of chemotherapy-induced neutropenia.
The marketing authorisation application was submitted in September 2017 and is supported by a comprehensive set of biosimilarity data from analytical, biofunctional and clinical studies comparing Pelmeg and Neulasta. The clinical development program included two studies, which confirmed the analytical and biofunctional similarity of Pelmeg and Neulasta in highly sensitive clinical study settings.
The European Commission will review the CHMP’s positive opinion. If adopted, the Commission will grant a centralised marketing authorisation, which will be valid in all member countries of the EU.
