EMA accepts regulatory submission for proposed Herceptin biosimilar

pharmafile | August 26, 2016 | News story | Medical Communications |  Biocon, EMA, Herceptin, Mylan, biosimilar, regulatory, submission, trastuzumab 

Mylan and Biocon have announced that the European Medicines Agency (EMA) has accepted for review its marketing authorisation application for a proposed biosimilar of Roche’s Herceptin (trastuzumab), to treat certain HER2-positive breast and gastric cancers.

The pair indicates that this may be the first biosimilar for Herceptin that the EMA accepts for review. The submission includes a range of analytical, functional and pre-clinical data, as well as confirmation of the comparable efficacy and safety of the biosimilar.

Mylan President Rajiv Malik comments: “The acceptance of our regulatory submission of our proposed biosimilar Trastuzumab in Europe is another example of the strong progress we continue to make across our broad biosimilars portfolio. Following our successful commercialisation in India and emerging markets, we look forward to our pending launch in Europe. Europe represents a key market for more affordable versions of these important products, as governments across the region strive to reduce healthcare costs. We look forward to continuing to work to bring this product to patients upon approval.”

Arun Chandavarkar, CEO and Joint Managing Director, Biocon, says: “The regulatory submission for proposed biosimilar Trastuzumab in Europe takes us a step closer towards enabling affordable access to this critical biologic therapy for the treatment of HER2-positive breast cancer. We remain committed to bring a diversified portfolio of high-quality, life-enhancing biosimilars to patients globally.”

Sean Murray