FDA Accepts Biogen Biologics License Application for BIIB800, A Biosimilar Candidate Referencing ACTEMRA® (tocilizumab)

2022-12-09

临床3期上市批准引进/卖出临床结果

CAMBRIDGE, MA, USA I December 09, 2022 IBiogen Inc. (Nasdaq: BIIB) – announced that the U.S. Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (aBLA) for BIIB800, a biosimilar candidate referencing ACTEMRA®1 (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody.

ACTEMRA® is indicated for several indications, including moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis and systemic juvenile idiopathic arthritis.

“The FDA filing is supported by Phase 3 data from a comparative clinical trial demonstrating equivalent efficacy and a comparable safety and immunogenicity profile to the reference product,” said Ian Henshaw, Head of Global Biosimilars at Biogen. “We look forward to working with regulators to bring this potential treatment option for people with immune mediated inflammatory diseases.”

As previously reported, positive Phase 32 data for BIIB800 up to week 24 was presented at the European Congress of Rheumatology on June 3, 2022. The BIIB800 clinical program included a Phase 3 multicenter, multinational, randomized, double-blind, parallel-group, active-control global study, designed to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of BIIB800 compared to ACTEMRA® in 621 patients with moderate to severe rheumatoid arthritis with inadequate response to methotrexate. The data from the Phase 3 comparative clinical trial demonstrated that the biosimilar candidate BIIB800 has equivalent efficacy and comparable safety and immunogenicity profile to the reference tocilizumab product. The one-year Phase 3 results were presented at the American College of Rheumatology (ACR) on November 10, 2022.

Biosimilars are biological products that have been demonstrated to be similar in efficacy and safety to the originator’s reference product, with the advantage that they offer healthcare savings and promote sustainable access to therapies. Savings in the United States from 2020 until 2024 as a result of biosimilars across therapeutic areas are projected to exceed $100 billion.3

In September 2022, the Marketing Authorization Application (MAA) for BIIB800 was accepted for review by the European Medicines Agency (EMA).

Biogen announced in April 2021 that it entered into a commercialization and license agreement with Bio-Thera Solutions, Ltd. to develop, manufacture and commercialize BIIB800. Biogen has exclusive regulatory, manufacturing and commercial rights to BIIB800 in all countries excluding China (including Hong Kong, Macau and Taiwan).

About Biogen

As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and developed the first and only approved treatment to address a defining pathology of Alzheimer’s disease. Biogen is also commercializing biosimilars and focusing on advancing one of the industry’s most diversified pipelines in neuroscience that will transform the standard of care for patients in several areas of high unmet need.

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References:

SOURCE: Biogen

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