EMA accepts marketing application of Biocon, Mylan product

NEW DELHI: Biotech major Biocon said European Medicines Agency (EMA) has accepted for review Mylan's marketing authorisation application for their biosimilar product Pegfilgrastim, which is used to reduce the duration of neutropenia for cancer patients.

Mylan and Biocon, who co-developed the proposed biosimilar, received EMA's acceptance of the submission for review, Biocon said in a statement.

"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," Arun Chandavarkar, CEO & Joint Managing Director Biocon said.

Once approved, this product will enable enhanced access to a cost-effective alternative for patients undergoing chemotherapy in the EU, he added.

"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," Mylan President Rajiv Malik said.

Pegfilgrastim is prescribed for cancer patients to help them with some of the side-effects of their treatment. It reduces the duration of neutropenia which is a result of chemotherapy treatment.

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 product 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.