 "European drug regulator accepts Mylan & Biocon application for biosimilar trastuzumab")
Mylan NV and Biocon Ltd yesterday announced that the European Medicines Agency (EMA) has accepted for review Mylan’s marketing authorisation application (MAA) for a proposed biosimilar trastuzumab, which is used to treat certain HER2-positive breast and gastric cancers. This is the second biosimilar submission developed by the partnership that has been accepted for review in Europe. Last month, Mylan’s MAA for the proposed biosimilar pegfilgrastim was accepted for review by EMA.
Mylan and Biocon, which have co-developed this proposed biosimilar, anticipate that this may be the first MAA for a trastuzumab biosimilar accepted by the EMA for review.
This filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics (PK) and confirmatory efficacy & safety global clinical trials for trastuzumab. The PK study had demonstrated measured bioequivalence of Mylan’s and Biocon’s proposed trastuzumab biosimilar relative to that of the reference drug. The second study, the ‘Heritage Study’, evaluated the efficacy, safety and immunogenicity of the proposed biosimilar Trastuzumab in comparison to branded Trastuzumab.
Rajiv Malik, president, Mylan, commented, “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, 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.”
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. Mylan has exclusive commercialisation rights for the proposed biosimilar 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.