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Biocon and its partner Mylan announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a positive opinion in which they recommended the approval of their trastuzumab biosimilar for bad cancer.
The CHMP's recommendation will be the European Union's Medicines Regulatory Authority before making an approval decision. The approval of the EMA should take place by the end of the year.
According to IQVIA, Trastuzumab, a biosimilar version of the Swiss drug manufacturer Herceptin, achieved a turnover of $ 1.9 billion in Europe for the twelve-month period ended July 31.
Biocon -The trastuzumab or Ogivri Michael was approved by the USFDA in December 2017 and is the first biosimilar approved by the USFDA for Herceptin in the United States. The drug has not yet been launched in the United States because of a settlement between Mylan and Roche.
The terms of the agreement or the launch date are not public. Some commentators have indicated that a biosimilar biosimilar from Biocon-Mylan would be available in the second half of 2019.
If the EMA agrees, it will be Biocon's third biosimilar endorsement in the EU. The company had previously received approvals and launched biosimilars Pegfilgrastim and insulin glargine.
"We will continue to implement our biosimilars strategy of expanding affordable access to high-quality products to fight serious diseases such as cancer," said the Director General of Biocon. , Arun Chandavarkar.
Previously, Biocon had fetched $ 200 million in revenue from its biosimilar portfolio for FY19.
Mylan and Biocon are exclusive partners in a broad portfolio of biosimilar and drug-based products. # 39; insulin.
products co-developed by Mylan and Biocon for the global market.
Mylan holds the exclusive rights to market the product in the United States, Canada, Japan, Australia, New Zealand, as well as in the countries of the European Union and the Association. European free trade. co-exclusive marketing rights with Mylan for the product in the rest of the world.
As Biocon develops and Nyl makes the drug, Mylan takes care of regulatory approvals and marketing.
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