Tagged as: FDA

FDA Approves Samsung Bioepis's HADLIMA (adalimumab-bwwd)

Earlier this week, the U.S. FDA approved Samsung Bioepis’s  HADLIMA (adalimumab-bwwd), a biosimilar referencing HUMIRA, for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. HADLIMA is the fourth adalimumab biosimilar to receive approval in the U.S. According to…

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Insulin Biosimilars Update

Some noteworthy regulatory and litigation events related to insulin biosimilars have occurred recently. On May 13, 2019, FDA held a public hearing entitled “The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products” at FDA’s White Oak campus in Silver Spring, Maryland. …

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FDA to Hold Hearing Concerning Insulin Costs

The FDA has announced that it will hold a hearing to discuss affordability of and access to insulin products, including issues concerning the development of biosimilar and interchangeable insulin products.  The hearing will cover scientific standards for evaluating biosimilarity and interchangeability of insulin products; other regulatory considerations, such as whether…

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FDA's New Draft Biologic Naming Guidance

On March 4, 2019 FDA announced the availability of a draft guidance titled Nonproprietary Naming of Biological Products: Update (“Naming Guidance”). According to FDA’s announcement the Naming Guidance reflects FDA’s current thinking on biological products licensed under Section 351 of the Public Health Service Act (“PHS Act”). This draft guidance serves…

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FDA approves a fourth biosimilar of HERCEPTIN

Yesterday, the U.S. FDA approved Pfizer’s Trazimera™ (trastuzumab-qyyp), a biosimilar of Genentech’s Herceptin®, for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.  These indications are the same as those for which the reference product is approved. Trazimera™ is the fourth trastuzumab biosimilar, and the…

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FDA Approves New Trastuzumab Product

On February 28, 2019, the FDA approved Genentech’s Herceptin Hylecta (trastuzumab and hyaluronidase-oysk).  According to a press release from Roche, Genentech’s parent company:  “This new treatment includes the same monoclonal antibody as intravenous Herceptin® (trastuzumab) in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under…

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