JOIN US Mylan and Biocon on Thursday announced that the European Medicines Agency (EMA) has accepted for review Mylan’s Marketing Authorisation Application (MAA) for a proposed biosimilar Trastuzumab.
It will be 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.
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. We remain committed to bring a diversified portfolio of high-quality, life-enhancing biosimilars to patients globally.”