EMA Accepts Mylan, Biocon Application For Herceptin Biosimilar

The European Medicines Agency (EMA) has accepted a marketing authorization application filed by Mylan for a proposed biosimilar referencing Roche's Herceptin (trastuzumab), for certain HER2-positive breast and gastric cancers. Herceptin, one of Roche's top-selling oncology drugs, had 2015 global sales of CHF 6.5 billion ($6.6 billion).

Mylan and Biocon, a Bangalore, India-based biotechnology company, co-developed this proposed biosimilar. Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs. Trastuzumab is one of six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights to trastuzumab in the US, Canada, Japan, Australia, New Zealand, 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.

In the US, Herceptin is approved to treat HER2 over-expressing breast cancer and HER2 over-expressing metastatic gastric as well as gastroesophageal junction adenocarcinoma.

The trastuzumab biosimilar is the second biosimilar submission developed by the partnership between Mylan and Biocon that has been accepted for review in Europe. In July 2016, Mylan’s MAA for a proposed biosimilar of pegfilgrastim was accepted for review by the EMA. Pegfilgrastim, the active ingredient in Amgen’s Neulasta. Neulasta is one of Amgen’s top-selling drugs with 2015 revenues of $4.7 billion.

Source: Mylan

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