European Medicines Agency (EMA) has accepted for review Mylan’s application to market biosimilar Trastuzumab, co-developed with Biocon, that is used to treat certain breast and gastric cancers.
This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe, global pharma major Mylan and Biocon said in a statement today.
Mylan and Biocon anticipate that this may be the first marketing authorisation application (MAA) for a Trastuzumab biosimilar accepted by the EMA for review, it added.
“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,” Mylan President Rajiv Malik said.
Europe represents a key market for more affordable versions of these important products, as governments across the region strive to reduce healthcare costs, he added.
“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,” Biocon CEO and Joint MD Arun Chandavarkar said.
Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs. The proposed biosimilar Trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace, the statement said.
While Mylan has exclusive commercialisation rights for Trastuzumab in the US, Canada, Japan, Australia, New Zealand, the European Union and European Free Trade Association countries, Biocon has co-exclusive commercialisation rights with Mylan for the product in the rest of the world, it added.
A biosimilar medicine is a biological medicine that is developed to be similar to an existing biological medicine and has demonstrated no clinically meaningful differences in safety, purity, and potency compared to that of the reference biologic.