Tagged as: Amgen

American Academy of Ophthalmology Pushes Back Against Bevacizumab Biosimilar Use in Treating Ophthalmic Conditions

On July 29, 2021, the American Academy of Ophthalmology (AAO) released a statement urging the Centers for Medicare & Medicaid Services (CMS) to prohibit Insurance companies from requiring ophthalmologists to use new biosimilar drugs as alternatives to Avastin for treatment in eye diseases.  The statement alleges that certain large healthcare…

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Amgen v. Hospira Pegfilgrastim Case Stayed Pending Potential Summary Judgment Practice

On June 16, 2021, the District Court for the District of Delaware issued a claim construction order construing a key term in the ongoing patent dispute between Amgen and Hospira over Hospira’s proposed biosimilar of Amgen’s Neulasta® (pegfilgrastim).  In the Order, the Court construed the term “between about 0.1 M…

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Sanofi Files Opposition to Amgen’s Petition for Federal Circuit to Reconsider Decision Invalidating Praluent Patents

As we previously reported, in April 2021, Amgen petitioned for the full Federal Circuit to reconsider the decision of a three-judge panel that two of Amgen’s patents, U.S. Patent Nos. 8,829,165 (the “’165 patent”) and 8,859,741 (the “’741 patent”), covering its cholesterol-lowering drug Repatha® (evolocumab) and Sanofi’s Praluent® (alirocumab), were…

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Study Concludes Two Adalimumab Biosimilars may be as Safe and Effective as Originator

An article published last week in Scientific Reports describes the results of a multicenter prospective study evaluating the safety and efficacy of switching IBD patients from Abbvie’s Humira product to either of two adalimumab biosimilars, ABP501 (Amgen) and SB5 (Samsung Bioepsis).  The authors concluded from this study that both biosimilars…

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Q4 2020 and Full Year Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from fourth quarter and full year 2020 earnings reports recently released by biologics and biosimilars companies: At the end of last month, Johnson & Johnson reported fourth quarter sales of $22.5 billion reflecting growth of 8.3% and full year sales of $82.6 billion reflecting growth of…

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CHMP adopts positive opinions on two bevacizumab biosimilars

At its January meeting last week, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval for two biosimilar bevacizumab medicines, Alymsys and Oyavas.  Mabxience Research SL’s Alymsys and STADA Arzneimittel AG’s Oyavas both received positive opinions for the treatment of carcinoma of the colon or rectum, breast cancer, non-small…

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