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Biocon Biologics (BBL), a biosimilars company and subsidiary of Biocon, has announced that Health Canada has granted a Notice of Compliance (NOC) for YESAFILI (aflibercept), a biosimilar to EYLEA (aflibercept) injection. mL, and was granted on 26 June 2025. The company has scheduled the product’s Canadian launch for 4 July 2025.
Market share is often held up as the most relevant metric for the success of a biosimilar class. I believe there are other metrics, like cost savings or signs of greater patient access, that should also be used to define biosimilars’ successes or failures. the first biosimilar was launched in September 2015. In the U.S.,
In its June 2025 meeting, the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted positive opinions for six biosimilar medicines. Additionally, on June 23, 2025, Alvotech announced that the EMA adopted a positive opinion recommending market approval of AVT06.
Published June 23, 2025 Amy Baxter Staff Reporter post share post print email license Stock via Getty Images Listen to the article 6 min This audio is auto-generated. Mounjaro reached nearly $12 billion in revenue last year, while Jardiance, Lilly’s diabetes medication co-owned with Boehringer Ingelheim, topped $10 billion for the year.
Biosimilars have emerged as a game-changing force, promising to revolutionize patient access to life-saving biologics while simultaneously reducing healthcare costs. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 billion by 2025, growing at a CAGR of 34.2%
Robert Barrie June 23, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Bayer’s Eylea is a heavyweight of the ophthalmic drug landscape, approved for a range of eye diseases. Go deeper with GlobalData Reports LOA and PTSR Model - Aflibercept Biosimilar in Age Related Macular. CucuMberStudio via Shutterstock.
To move from generics to novel drug development, Indian companies must invest heavily in R&D for innovative therapies like biosimilars, cell and gene therapies, and specialty drugs. Similarly, Dr. Reddy’s and Cipla are exploring the biosimilar and complex generics space, focusing on areas like respiratory and oncology drugs.
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the grant of marketing authorizationsforthree biosimilar productsAmgens PAVBLU and SKOJOY, and CuraTeQ Biologics DYRUPEG.
announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab). According to the press release, PYZCHIVA will be available in the United States beginning on February 22, 2025, pursuant to a settlement and license agreement between Samsung Bioepis and Janssen Biotech Inc.
On February 18, 2025, Alvotech and Teva Pharmaceuticals (Teva) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to EYLEA 2 milligram (mg). Alvotech is currently developing AVT29, a biosimilar candidate for EYLEA HD 8 mg.
The authors explained that the market has an optimistic view about the remainder of 2025. These include innovations in biotechnology, the expansion of biosimilar medicines and increasing investment in research and development.
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Boston, US-based Alexion spent a lot of 2019 arguing the merits of remaining independent, saying that while Soliris is approaching the end of its patent life – with heavyweight competitors like Amgen already eyeing the biosimilar market for the drug – Ultomiris and its pipeline could help drives sales to $9 to $10 billion in 2025.
billion takeover bid for Verve Therapeutics, upgrading a collaboration between the two companies that dates back to 2023. billion takeover bid for Verve Therapeutics, upgrading a collaboration between the two companies that dates back to 2023.
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Ximluci is expected to be available in the UK in 2023 The approval for Ximluci was granted through the EC decision reliance procedure, whereby the MHRA’s decision was based on the EC Ximluci was approved in the UK for wet AMD, DME, diabetic retinopathy, RVO, and visual impairment due to choroidal neovascularization in adults.
billion, expanding its pipeline with a potential first-in-class treatment for autoimmune diseases as well as adding a novel RNA delivery system to its portfolio. billion, expanding its pipeline with a potential first-in-class treatment for autoimmune diseases as well as adding a novel RNA delivery system to its portfolio.
The sNDA submitted July 8, 2025, is based on a phase 3 randomized withdrawal trial involving adults with stable schizophrenia who continued treatment with lumatperone for a 26-week double-blind phase. Time to relapse was significantly delayed in the lumatperone arm compared to placebo.
CMS should draw on lessons from previous transitions, including biosimilar coverage rollouts and site-of-care policy shifts, to avoid known implementation pitfalls. 95 (May 15, 2025): 20674, https ://www.federalregister.gov/d/2025-08607. 95 (May 15, 2025): 20674, https ://www.federalregister.gov/d/2025-08607.
It is not indicated for type 1 diabetes and carries a boxed warning for thyroid C-cell tumors, with unknown risk in humans. The presentation emphasized early intervention and personalized treatment plans in managing type 2 diabetes, shifting from "treating to failure" to "treating to target.
In an interview with Pharmacy Times ®, Diana Isaacs, PharmD, BCPS, BC-ADM, BCACP, CDCES, FADCES, FCCP, remote monitoring program coordinator and endocrinology clinical pharmacy specialist at the Cleveland Clinic, shares insights about the upcoming American Diabetes Association 85th Scientific Sessions.
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