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[THE INVESTOR] Ontruzant from Samsung Bioepis, a biosimilar for the treatment of bad cancer, referring to Roche's Herceptin, was approved by the US Food and Drug Administration on Jan. 19.
Ontruzant is the third FDA approved biosimilar for bad cancer antibodies from the Swiss company Roche. Its approval by the FDA is preceded by Ogivri of Mylan in December 2017 and by Herzuma of Celltrion in December 2018.
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The biosimilars of the three companies are expected to hit the US biopharmaceutical market simultaneously in June, when Herceptin patents will expire. Herceptin is one of the most effective antibodies in the world. After being approved by the FDA in 1998, Herceptin is Roche's best-selling monoclonal antibody, generating annual sales estimated at more than $ 2.6 billion in the United States and $ 7 billion in the United States. world.
Ontruzant has already been sold in the UK since March 2018, after obtaining approval from the European Medicines Agency in November 2017. Traizer, Pfizer, Herzuma of Celltrion, Amgen and its partner, Allergan, are also approved by the EMA.
In the United States, Ontruzant will be marketed by Merck Sharp & Dohme, the same company that sells to Samsung Bioepis the other American biosimilar, Renflexis. Available in the United States since July 2017, Renflexis is a tumor necrosis factor inhibitor used to treat Crohn's disease, rheumatoid arthritis, among others.
Samsung Bioepis is a joint venture of Samsung BioLogics and Biogen. The first was accused of accounting irregularities at the time of its IPO. Samsung BioLogics stock trades were temporarily suspended for one month before being standardized in December.
By Lim Jeong-yeo / The Korea Herald ([email protected])
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