Biocon and Mylan announced that the European Medicines Agency (EMA) has accepted for review, the latter’s Marketing Authorization Application (MAA) for the proposed biosimilar Pegfilgrastim, which is used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy.
 
The two companies  which 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 prestigious European Society of Medical Oncology (ESMO) Annual Congress to be held in Copenhagen in October 2016.
 
Arun Chandavarkar, CEO & joint managing director, Biocon, said,“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 high-quality, life-enhancing biosimilars to patients globally.”
 
“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 programme 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,” Rajiv Malik, president, Mylan.

Both Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars andgeneric insulinanalogs. The proposed biosimilar Pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization 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 commercialization rights with Mylan for the product in the rest of the world.