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…
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…
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….
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. …
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…
Amgen recently released a preview of its 2022 Trends in Biosimilars Report, which includes an analysis of the trends in US biosimilar launches and approvals; a timeline of biosimilar approvals and launch dates; trends in pricing, uptake, and total drug spend; and considerations for the future of biosimilars. According to…
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…
On June 7, 2022, from 9:30-10:50 AM Eastern Time, FDA is hosting, virtually, its annual public meeting for public comment on Financial Transparency and Efficiency of the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), and Generic Drug User Fee Amendments (GDUFA). At the meeting, FDA will…
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…
The annual Food & Drug Law (FDLI) conference will be held on June 14-15, bringing together experts from the federal government, industry, the private bar, non-profit, patient and consumer advocates, consulting organizations, and academia to address complex legal, regulatory, compliance, and policy issues facing the FDA-regulated industry. Goodwin is a…