European drug regulator accepts Mylan-Biocon application for biosimilar Pegfilgrastim

The European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) of Biocon and Mylan for their biosimilar Pegfilgrastim, which is prescribed for cancer patients to help them with some of the side-effects of their treatment. It reduces the duration of neutropenia (low levels of neutrophils, a type of white blood cell that fights infections) and the incidence of febrile neutropenia (neutropenia with fever) that are a result of their chemotherapy treatment.

Mylan and Biocon, who have co-developed the proposed biosimilar, received EMA's acceptance of the submission for review. In addition to analytical, functional and pre-clinical data, the application includes clinical data from pivotal pharmacokinetic/pharmacodynamic (PK/PD) and confirmatory efficacy, safety and immunogenicity studies completed earlier in 2016. The results from the studies are expected to be presented at the European Society of Medical Oncology (ESMO) Annual Congress to be held in Copenhagen in October 2016.

“The regulatory submission of biosimilar Pegfilgrastim with the EMA by our partner Mylan marks another significant milestone in our journey to develop affordable biologics for cancer patients. Once approved, this product will enable enhanced access to a cost-effective alternative for patients undergoing chemotherapy in the EU. We are committed to bring a diversified portfolio of highquality, life-enhancing biosimilars to patients globally,” said Arun Chandavarkar, CEO & joint managing director, Biocon.

Mylan President Rajiv Malik added, “We continue to make great progress across our biosimilars portfolio, which represents one of the industry’s largest and most diversified portfolios in development. This milestone in our Pegfilgrastim program represents yet another important step in bringing more affordable versions of these critical products to market, with Europe representing an exciting opportunity for Mylan in this area.”

Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and generic insulin analogs. The proposed biosimilar Pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialisation rights for the proposed biosimilar Pegfilgrastim in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialisation rights with Mylan for the product in the rest of the world.