The FDA issued a draft guidance today titled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.” In this guidance, the FDA addresses the following issues: Submission of an application seeking licensure of a proposed biosimilar or proposed interchangeable…
Earlier this week FDA issued a draft guidance on “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products.” The draft guidance addresses the truthful and non-misleading manner in which data and information concerning reference or biosimilar products must be presented. The draft guidance does not address issues…
The U.S. Food and Drug Administration and the Federal Trade Commission today released a joint statement regarding collaboration to advance competition in the market for biologic products. According to the FDA press release, “[t]his joint statement describes key steps the agencies will take to address false or misleading promotion about…
In passing H.R. 1865, the Further Consolidated Appropriations Act, 2020 (“FCAA”), on December 20, 2019, Congress adopted a number of changes to the BPCIA that impact biosimilars. Under the BPCIA, approved NDAs for biological products will be “deemed to be a license” as if approved under BLAs as of March…
Beginning on March 23, 2020, the FDA will begin to accept aBLAs for biosimilar insulin products referencing previously approved insulin products. Prior to this date, insulin products have been approved pursuant to New Drug Applications and, thus, insulin generics were not eligible for approval as aBLAs. The transition period for…
Samsung Bioepis Co., Ltd announced today that the FDA has accepted for review an aBLA for SB8, a bevacizumab biosimilar to Roche’s Avastin® product. If approved, SB8 will be commercialized in the US by Merck & Co.
Last week, the FDA compiled a preliminary list of NDAs that will be converted to BLAs in view of the new interpretation of the terms “protein” and “biological product” in the FDA’s “Deemed To Be A License” draft guidance, which was released in December 2018. In the draft guidance, the…
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…
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. …
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…