Mylan biosimilar application moves forward
The European Medicines Agency has accepted pharmaceutical company Mylan’s request to review its application for a biosimilar of Herceptin (trastuzumab).
The drug, developed by Roche, is used to treat breast and gastric cancers.
The acceptance marks the second time that Mylan, along with its partner company Biocon, has had its calls for a review of a biosimilar application accepted in Europe.
A marketing authorisation application for a biosimilar of Amgen’s Neulasta (pegfilgrastim) was also accepted for review last month.
Arun Chandavarkar, CEO of Biocon, said: “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.”
Rajiv Malik, president of Mylan, added: “Europe represents a key market for more affordable versions of these im portant 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.”
