Samsung Bioepis and Biogen Receive European Commission (EC) Approval for Aflibercept Biosimilar, OPUVIZ™ [Yahoo! Finance]
Biogen Inc. (BIIB)
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Source: Yahoo! Finance
EC approval based on robust totality of evidence confirming biosimilarity to reference aflibercept in terms of quality, efficacy, and safety INCHEON, South Korea and CAMBRIDGE, Mass., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission (EC) has approved OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea (aflibercept), developed and registered by Samsung Bioepis. OPUVIZ, also known as SB15, is approved in adult patients for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV). “Retinal disorders are affecting millions of people's lives in Europe, yet many patients face barriers to treatment due to high costs,
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News
- Why Biogen Inc. (BIIB) is a Top Value Stock for the Long-Term [Yahoo! Finance]Yahoo! Finance
- Biogen Inc. (NASDAQ: BIIB) was downgraded by analysts at StockNews.com from a "strong-buy" rating to a "buy" rating.MarketBeat
- Biogen Inc. (NASDAQ: BIIB) was upgraded by analysts at StockNews.com from a "buy" rating to a "strong-buy" rating.MarketBeat
- Biogen Inc. (NASDAQ: BIIB) was downgraded by analysts at BMO Capital Markets from an "outperform" rating to a "market perform" rating. They now have a $164.00 price target on the stock, down previously from $230.00.MarketBeat
- Biogen Inc. (NASDAQ: BIIB) was downgraded by analysts at Stifel Nicolaus from a "buy" rating to a "hold" rating. They now have a $175.00 price target on the stock.MarketBeat
BIIB
Earnings
- 10/31/24 - Beat
BIIB
Sec Filings
- 12/9/24 - Form 4
- 12/9/24 - Form 4
- 12/9/24 - Form 144
- BIIB's page on the SEC website