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.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
