Tagged as: FDA

Biocon and Alvotech Release Statements on FDA Inspections

On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia.  The inspections took place between August 11 and August 30, 2022.  The inspections were triggered by three preapproval inspections…

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Biosimilar Regulatory Approval Updates

Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD).  Teva entered into a strategic partnership with Bioeq AG for the exclusive commercialization of ranibizumab.  According to the press release, RANIVISIO (ranibizumab) will be the first…

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FDA Workshop on Sept. 19, 2022: Increasing the Efficiency of Biosimilar Development Programs

The FDA is hosting a virtual public workshop on September 19, 2022 on “Increasing the Efficiency of Biosimilar Development Programs.”  The workshop will focus on comparative clinical studies and “discuss possible innovative ideas to improve the efficiency of biosimilar development.”  The workshop will include detailed discussion on the statistical methods…

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Celltrion Files IND with FDA for Adalimumab Biosimilar

As reported by Pulse and DailyPharm Korea, Celltrion recently filed an Investigational New Drug (IND) application with the FDA for a global Phase 3 clinical trial aimed at demonstrating its biosimilar’s (YUFLYMA) interchangeability with HUMIRA (adalimumab).  The trial will evaluate the pharmacokinetics, efficacy, and safety of YUFLYMA in 366 patients with plaque psoriasis….

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FDA Accepts for Review Fresenius Kabi’s BLA for Tocilizumab Biosimilar

On August 1, 2022, Fresenius Kabi announced that the FDA accepted for review its Biologics License Application (BLA) for MSB11456, a biosimilar candidate for ACTEMRA (tocilizumab).  The BLA includes both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations.  This is the first BLA accepted by FDA for a tocilizumab biosimilar. …

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Sandoz & Polpharma Announce FDA and EMA Acceptance of Applications for Natalizumab Biosimilar

Sandoz announced this week that the U.S. Food and Drug Administration (FDA) has accepted the first-ever biologics license application (BLA) for a proposed natalizumab biosimilar to Biogen’s TYSABRI®.  The proposed natalizumab biosimilar is for treatment of adults with highly active relapsing-remitting multiple sclerosis (RRMS).  The application is for an intravenous…

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FDA Approves Amgen’s RIABNI™ (Rituximab-arrx) for Adults With Moderate to Severe Rheumatoid Arthritis

On June 6, 2022, Amgen announced that the U.S. Food and Drug Administration has approved Amgen’s RIABNI (rituximab-arrx), a biosimilar to Genentech’s RITUXAN®, in combination with methotrexate for treatment of moderate to severely active rheumatoid arthritis (RA).  RIABNI has been approved since December 2020 for treatment of adult patients with…

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Trial Scheduled for April 2024 in BMS Patent Case Against AstraZeneca Regarding Anti-PDL1 Antibodies

The District of Delaware has issued a scheduling order, setting a trial for April 2024, in Bristol Myers Squibb’s (BMS) patent case against AstraZeneca.  BMS filed its complaint against AstraZeneca on March 17, 2022, alleging infringement of eight patents related to anti-PD-L1 antibodies.  According to BMS, the case “relates to…

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