Trastuzumab, the biosimilar version of Swiss drug maker Roche’s Herceptin had brand sales of $1.9 billion in Europe for the 12 months ended July 31, according to IQVIA.
Biocon and its partner Mylan announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of their breast cancer biosimilar Trastuzumab.
The CHMP‘s recommendation will be considered by European Union drug regulator before it takes a decision on approval. EMA’s decision on approval is expected by year-end.
Trastuzumab, the biosimilar version of Swiss drug maker Roche’s Herceptin, had brand sales of $1.9 billion in Europe for the 12 months ended July 31, according to IQVIA.
Biocon-Mylan’s Trastuzumab or Ogivri was approved by the USFDA in December 2017 and is the first USFDA-approved biosimilar for Herceptin in the US. The drug is yet to be launched in US due to settlement between Mylan and Roche.
The terms of the deal or launch date are not public. Some commentators have indicated that an entry of Biocon-Mylan’s Trastuzumab biosimilar in second half of 2019.
If EMA gives its nod, it will be third biosimilar approval for Biocon in EU. The company earlier received approvals and launched biosimilars Pegfilgrastim and insulin glargine.
"We shall continue to execute on our biosimilars strategy of expanding affordable access to high quality products targeting critical illnesses like cancer,” said Biocon Chief Executive Officer & Joint Managing Director, Arun Chandavarkar.
Biocon earlier guided $200 million revenue in FY19 from its biosimilar portfolio.
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products.
Neulasta is one of 11 biologic and insulin products co-developed by Mylan and Biocon for the global marketplace.
Mylan has exclusive commercialization rights for the product in the US, Canada, Japan, Australia, New Zealand and in 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.While Biocon develops and manufactures the drug, Mylan takes care of regulatory approvals and marketing.