Mylan And Biocon Says EMA Accept Its Regulatory Submission Of Biosimilar Pegfilgrastim

Mylan N.V. MYL and Biocon Ltd. revealed that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for their proposed biosimilar Pegfilgrastim for review. The drug is used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy with the exception of chronic myeloid leukaemia and myelodysplastic syndromes.

Mylan and Biocon have co-developed the proposed biosimilar that got the EMA's acceptance of the submission for review. Aside from the analytical, functional and pre-clinical data, the application included clinical data from pivotal Pharmacokinetic / Pharmacodynamic (PK / PD) and confirmatory efficacy, safety and immunogenicity studies completed previously in the current year.

The companies indicated the results from the trials were expected to be presented at the prestigious European Society of Medical Oncology (ESMO) Annual Congress to be held in Copenhagen in October.

Mylan President, Rajiv Malik, stated, "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."

Both the companies are exclusive partners on a wider portfolio of biosimilars, as well as, generic insulin analogs. The proposed biosimilar Pegfilgrastim was one of the six biologic products co-developed by two firms for the global marketplace.

Mylan said it has exclusive commercialization rights for the planned biosimilar Pegfilgrastim in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries.