EMA accepts review for Mylan and biocon’s trastuzumab biosimilar

mylanMylan N.V. and Biocon Ltd. said the European Medicines Agency accepted for review Mylan’s Marketing Authorization Application for a proposed biosimilar version of biosimilar Trastuzumab, a medicine used to treat breast and gastric cancers.

This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe. Mylan’s MAA for the proposed biosimilar Pegfilgrastim, an injection used to reduce the chance of infection in cancer patients, was accepted for review by EMA last month.

Mylan and Biocon, who co-developed this proposed biosimilar, anticipate that this may be the first MAA for a Trastuzumab biosimilar accepted by the EMA for review.

“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”, said Mylan President, Rajiv Malik.

“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,” said Arun Chandavarkar, CEO and Joint Managing Director, Biocon.

Mylan N.V. is a global generic and specialty pharmaceuticals company registered in the Netherlands and with operational headquarters in Hatfield, Hertfordshire in the United Kingdom.

Biocon Limited is an Indian biopharmaceutical company based in Bangalore, India. The Company manufactures generic active pharmaceutical ingredients that are sold in the developed markets of the United States and Europe.