On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.” The draft guidance is designed to “provide[] answers to commonly asked questions from applicants and other interested parties . . . regarding postapproval manufacturing changes . ….
Last month, the FDA issued draft guidance, which, if implemented, would remove a requirement for a switching study for demonstrating biosimilar interchangeability. For a biologic product that is administered more than once to an individual, a switching study refers to a clinical study used to determine the impact of alternating…
Samsung Bioepis (“Samsung”) announced on July 22 that the FDA approved its BLA for EPYSQLI, an eculizumab biosmilar referencing Alexion’s SOLIRIS. EPYSQLI has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. After…
On July 8, 2024, Outlook Therapeutics announced it received marketing authorization from UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of wet AMD in the UK. As we previously reported, Outlook Therapeutics received marketing authorization for LYTENAVA™ in the EU on May 28, 2024. With these approvals,…
On July 2, 2024, Fresenius Kabi (“Fresenius”) announced the immediate availability of TYENNE (tocilizumab-aazg), in a subcutaneous formulation, in the United States. TYENNE, a biosimilar to ACTEMRA (tocilizumab), was developed by Fresenius for use in the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic…
Samsung Bioepis’ PYZCHIVA On July 1, Samsung Bioepis Co., Ltd. announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab). PYZCHIVA is approved for the treatment of moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active…
This week, Biogen announced that the European Commission has approved TOFIDENCE, a tocilizumab biosimilar referencing Roche’s ROACTEMRA. TOFIDENCE was approved by the FDA in September 2023. TOFIDENCE is an intravenous formulation of an interleukin-6 receptor antagonist, and is approved for the treatment of moderate to severe active rheumatoid arthritis, polyarticular…
On May 28, 2024, the FDA approved Amgen’s BKEMV (eculizumab-aeeb), the first approved biosimilar of Alexion’s SOLIRIS (eculizumab). BKEMV was approved by the FDA as a 300 mg/30 mL (10 mg/mL) injection, for intravenous use in a single-dose vial as interchangeable with SOLIRIS. The product is approved for the treatment…
On May 31, 2024, Moderna announced that the FDA has approved its respiratory syncytial virus vaccine (“RSV”), mRESVIA (mRNA-1345). The vaccine was designed to protect adults from lower respiratory tract disease caused by an RSV infection. This is the second mRNA vaccine Moderna has developed to gain FDA approval, following…
In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab. On May 22, Sandoz announced that it received marketing authorization from the European Commission for its WYOST® and JUBBONTI® denosumab biosimilars. According to Sandoz, these…