EMA Accepts Pegfilgastim Biosimilar for Review
The agency will review Mylan and Biocon’s biosimilar to pegfilgrastim.
On July 21, 2016 Mylan and Biocon announced that the European Medicines Agency (EMA) has accepted for review Mylan’s Marketing Authorization Application (MAA) for its proposed biosimilar to pegfilgrastim. The drug was co-developed by Biocon and Mylan and is used to treat cancer patients. The drug minimizes the side effects of chemotherapy treatment, reducing the duration of neutropenia. According to Mylan, in addition to analytical, functional, and preclinical data, the application includes clinical data from pharmacokinetic/pharmacodynamic (PK/PD) studies completed earlier in 2016.
This comes after FDA sent a complete response letter to Sandoz for Neulasta, its biosimilar candidate to pegfilgrastim. Novartis released a statement in its Q2 report saying the company is working with FDA to address remaining questions.
Ushering in Industry 4.0 with the IDMO Model to Solve the CGT Manufacturing Bottleneck
May 28th 2025Global scale-up requires developing replicable processes that work the same no matter where they are performed. This can be accomplished with smart factories that utilize fully automated manufacturing platforms.
