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Ogivir, an anti-biosimilar developed by Indian biotech companies Biocon and Mylan, was recently approved in the European Union. The European Commission (EC) has granted a listing license to Mylan Ogivir, which is suitable for the treatment of HER2-positive early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic stomach cancer (MGC), which can be used as a monotherapy treatment or in combination with other drugs.
this year, the European Medicines Agency (EMA) Committee on Human Pharmaceutical Products (CHMP) issued a positive opinion on October 18, 2018 recommending the approval of Ogivir as a biosimilar for roche-branded drug Herceptin (common name: trastuzumab).
Herceptin is an overweight pound product from Roche, with global sales of $7 billion in 2017. To date, five Hercetin biosimilars have been approved in Europe and two in the United States.
in Europe, the European Commission approved ontruzant, a biosimilar from Mercadon and Samsung Bioepis in November 2017, the first EU-approved monobiotic drug; The European Commission also approved three crater-based biosimilars, including Celltrion and Teva's Herzuma, Amgen's Kanjinti, Pfizer's Trazimera, and Mylan and Baikang's Ogivir.
in the U.S., Mylan and Percocet's Ogivir were approved by the FDA in early December 2017, making it the first monosimilar drug approved by the U.S. market and the first individual biosimilar approved by the market. In mid-December, Celltrion and Teva's Herzuma were approved by the FDA to become the second monobiotic drug in the U.S. market.
According to Roche's 2018 Q3 results, Sales at Herceptin fell 10 percent in Europe in the first nine months of the year due to competition from trice-based anti-biosimilars, but in the U.S. market, there is currently no 12 percent increase in sales in the first nine months of the year. However, Roche is now actively preparing for competition in the U.S. market for the querceton mono-biosimilars that will come in 2019. (Bio Valley)
