Biologics

FDA Approves Biogen’s Actemra Biosimilar

FDA has approved a Biogen BLA for Tofidence (tocilizumab-bavi) intravenous formulation, the first biosimilar monoclonal antibody referencing Genentech’s arthritis drug Actemra. Tofidence is approved for treating moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

FDA approval of Tofidence was based on a “comprehensive analytical, non-clinical and clinical data package” submitted by Biogen 9/2022, according to the company. “Extensive analytical characterization of the structural, physicochemical, and biological properties of Tofidence was conducted and supports biosimilarity with the reference product,” it says. “Additionally, a randomized double-blind, single-dose, three-arm, parallel Phase I study compared the pharmacokinetics, safety and immunogenicity of Tofidence with both the U.S. and EU reference tocilizumab in healthy volunteers, while a randomized, double-blind, multi-dose, three-arm parallel Phase 3 study compared Tofidence with tocilizumab to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with rheumatoid arthritis inadequately controlled by methotrexate. The totality of evidence demonstrated Tofidence is a biosimilar of the reference biologic.”

In 2021, Biogen and Bio-Thera entered into a commercialization and license agreement for Tofidence. Under the agreement, Biogen has exclusive regulatory, manufacturing, and commercial rights to Tofidence in all countries excluding China.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome