Samsung Bioepis-Merck biosimilar to Roche's Herceptin wins FDA nod [Reuters]
Biogen Inc. (BIIB)
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Source: Reuters
Samsung Bioepis-Merck biosimilar to Roche's Herceptin wins FDA nod | Reuters 2 Min Read (Reuters) - The U.S. Food and Drug Administration said on Friday it had approved a biosimilar to Roche Holding AG’s blockbuster breast cancer treatment, Herceptin. The biosimilar, Ontruzant, is co-developed by Merck Sharp & Dohme Corp, a unit of Merck & Co Inc, and Samsung Bioepis Co Ltd, which is a joint venture between Samsung BioLogics and Biogen Inc. The approval here comes just a few weeks after the health regulator gave Celltrion Inc's Herzuma - another biosimilar to Herceptin - its nod to market it commercially. Herceptin, which generated sales of 7.01 billion Swiss francs in 2017, is one of the world’s most successful antibody drugs and has been a mainstay of Roche profits for many years. Herceptin and other complex medicines called biologics are made from living cells, making them difficult to copy with precision. Their similar versions are called biosimilars, instead of generics. The FDA
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News
- Biogen Receives Positive CHMP Opinion for TOFIDENCE™ (tocilizumab), a Biosimilar Referencing ROACTEMRA® [Yahoo! Finance]Yahoo! Finance
- Biogen Inc. (NASDAQ: BIIB) had its price target lowered by analysts at Barclays PLC from $215.00 to $200.00. They now have an "equal weight" rating on the stock.MarketBeat
- Shareholders 30% loss in Biogen (NASDAQ:BIIB) partly attributable to the company's decline in earnings over past year [Yahoo! Finance]Yahoo! Finance
- Biogen Inc. (NASDAQ: BIIB) had its price target raised by analysts at Wedbush from $213.00 to $215.00. They now have a "neutral" rating on the stock.MarketBeat
- Biogen Inc. (NASDAQ: BIIB) had its price target lowered by analysts at HC Wainwright from $325.00 to $300.00. They now have a "buy" rating on the stock.MarketBeat
BIIB
Earnings
- 4/25/24 - Beat
BIIB
Sec Filings
- 4/24/24 - Form 10-Q
- 4/24/24 - Form 8-K
- 4/12/24 - Form PRE
- BIIB's page on the SEC website