EMA to review Biocon, Mylan pegfilgrastim biosimilar for marketing authorization

Kiran Mazumdar-Shaw

Mylan ($MYL) and Bangalore-based Biocon said that the European Medicines Agency has accepted an application for review for marketing authorization of a biosimilar of pegfilgrastim (Neulasta) as both firms push wider into developed markets eager for lower-cost versions of blockbuster drugs.

In a release, the companies said the EMA review will focus on clinical data gathered for the submission of the therapy aimed at neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy.

The companies said they expect to present data on the clinical studies separately at the European Society of Medical Oncology annual congress in October.

Last month, Kiran Mazumdar-Shaw told the Business Standard that Biocon is a frontrunner in the biosimilar race in the European Union and the United States as it builds on a launch in Japan of a biosimilar of Sanofi's ($SNY) blockbuster Lantus (insulin glargine) that showed its chops.

"For a long time, our stock was being crucified because they thought we would never be able to get into the so-called developed markets," she said in June.

"They felt it would be a long time before biosimilars would be allowed in those markets. Suddenly, it happened [the first U.S. biosimilar was approved in 2015 while the EU has allowed these drugs since 2006] and the floodgates are open now. Europe and the U.S. are embracing biosimilars. Now that we are the first among the early entrants, it gives us confidence."

To be sure, regulators in the U.S., Japan and Europe appear to have stepped up reviews of biosimilars to coincide with patent expiry for several leading therapies, with Asian firms heavily in the mix, including one last week by Incheon-based Samsung Bioepis for a biosimilar of AbbVie's ($ABBV) blockbuster Humira (adalimumab), which the EMA accepted for marketing authorization review.

"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 and joint managing director of Biocon, said in the release.

The two firms have formed an exclusive partnership with 6 biologic products aimed at global approvals and sales. In the case of the pegfilgrastim biosimilar, Mylan holds rights in the U.S., Canada, Japan, Australia, and New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights in the rest of the world.

- here's the release

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