Bengaluru, dhns: Biopharma major Biocon and Mylan N V on Friday said that European Medicines Agency's committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Fulphila, a biosimilar to Amgen's Neulasta (Pegfilgrastim).
The CHMP positive opinion will now be considered by the European Commission. The decision on approval is expected by November 2018, the company said in a statement.
The CHMP positive opinion is based upon a review of evidence demonstrating biosimilarity. Data submitted as part of the Marketing Authorisation Application included similarity
assessment in analytical testing, preclinical and clinical studies that demonstrated biosimilarity to the reference product, Neulasta.
The Phase-I programme in healthy volunteers and Phase-III clinical study conducted in breast cancer patients receiving adjuvant and neoadjuvant chemotherapy, demonstrated no clinically meaningful differences in terms of pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity compared to Neulasta, the company added.