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The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. 1,2 The reflection paper also highlights the limitations and diminishing value of CES in many biosimilar development programmes.
Belgian anti-trust regulators are probing Roche over concerns that the drug company took steps to delay the entry of biosimilar versions of two of its cancer medicines. The agency also maintained Roche disseminated “erroneous information” about using biosimilars in combination therapy.
Biocon Biologics announced that the European Commission (EC) has granted marketing authorisation in the European Union (EU) for Vevzuo and Evfraxy biosimilars of Denosumab. Clinical data showed that both Denosumab biosimilars have comparable quality, safety, and efficacy to the reference product.
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. YESAFILI is the first biosimilar to EYLEA to be approved by Health Canada.
Sandoz has begun construction of a new biosimilars production facility in Brnik, Slovenia. The new high-tech facility will produce both existing and upcoming biosimilar medicines in Sandoz’s portfolio. . Ensuring a reliable supply of biosimilars in Europe “… With a commitment of over $1.1
3] The ultimate objective of biosimilar development should be to enhance patient outcomes through accessible, effective, and user-friendly therapies. [4] 4] Future biologics and biosimilars should prioritize self-administration capabilities, empowering patients and improving adherence. [5]
On June 25, 2025, Kashiv BioSciences announced positive topline results from its confirmatory Phase 3 trial of ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), in patients with chronic spontaneous urticaria.
On July 9, 2025, Lupin Limited and Zentiva Group announced a license and supply agreement to commercialize Lupin’s biosimilar of Certolizumab Pegol across multiple global markets. Under the agreement, Lupin will lead development, manufacturing, and supply of the biosimilar.
The 2025 launch of biosimilars to Johnson & Johnson’s Stelara (ustekinumab) marks another turning point in pharmacy benefit dynamics. But unlike the chaotic rollout of Humira biosimilars, pharmacy benefit managers (PBMs) came prepared.
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.
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. Stay tuned to Big Molecule Watch as we continue to cover developments in the biosimilars industry.
As biosimilars and generics flood the market, pricing pressures will intensify—particularly in oncology—challenging pharma companies to rethink revenue strategies, pipeline investments, and lifecycle management to safeguard long-term growth, says GlobalData. As a result, the US market is set to lose over $230 billion between 2025 and 2030.
Biocon Biologics announced that the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisations in the United Kingdom (UK) for Vevzuo and Evfraxy, biosimilars of Denosumab. Clinical data showed that both Denosumab biosimilars have comparable safety and efficacy to the reference product.
Bobolts, PharmD, BCOP, shares actionable strategies for oncology pharmacists to navigate biosimilar and 505(b)(2) drug implementation, manage payer and formulary complexities, and optimize cost-effective care delivery across oncology service lines.
Alvotech has moved one step closer to entering the Eylea (aflibercept 2 mg) biosimilar market, after a European Medicines Agency (EMA) panel recommended approval of its copycat biologic. Go deeper with GlobalData Reports LOA and PTSR Model - Aflibercept Biosimilar in Age Related Macular. CucuMberStudio via Shutterstock.
WYOST® and Jubbonti® are the first and only interchangeable FDA-approved denosumab biosimilars and are approved to treat all indications of the reference medicines, XGEVA® and Prolia®. Other developments continue in the denosumab biosimilars space. Other developments continue in the denosumab biosimilars space.
Brand Differentiation in an Era of Generics and Biosimilars What happens to a blockbuster brand when its patent expires? As generics and biosimilars continue to flood the market, brand erosion becomes a pressing concern. How can pharma brands differentiate from generics or biosimilars?
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Pharma companies will need to “rethink revenue strategies, pipeline investments, and lifecycle management to safeguard long-term growth”, as a greater number of biosimilars and generic medicines gain market entry, according to a recent report by the data and analytics company.
Lupin and a pan-European pharmaceutical company, Zentiva have entered into a license and supply agreement for commercialisation of Lupin’s biosimilar Certolizumab Pegol, across multiple markets globally. This alliance aims to accelerate the availability of high-quality, cost-effective biosimilar Certolizumab Pegol to patients worldwide.
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But Stelara, which became a megablockbuster in 2023, will leave a revenue gap that J&J has yet to fill as biosimilar competition heats up. In 2024, Johnson & Johnson became the first pharma with two megablockbusters: its immunology drug Stelara and an oncology therapy Darzalex.
24 Hours in the Hub Still Matters More Chris Dowd, ConnectiveRx June 16th 2025 Article Doubling down on patient access and support fundamentals will win out over Washington’s next move.
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The biosimilar showed similar efficacy, pharmacokinetics, pharmacodynamics, safety, quality of life, and immunogenicity in patients with chronic spontaneous urticaria (CSU).
By Larry K. Houck — A memorable Florida Orange Growers’ television ad campaign in the late 1970s proclaimed that “Orange juice from Florida isn’t just for breakfast anymore.”
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Related Videos Related Content Advertisement June 16th 2025 FDA Approves Ustekinumab-Stba, Biosimilar to Stelara, for Pediatric Patients With PsO or PsA Gillian McGovern, Associate Editor June 3rd 2025 S2. Subscribe Now!
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On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe. Samsung Bioepis announced a licensing, development, and commercialization agreement with NIPRO Corporation for multiple biosimilar candidates in Japan.
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Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd.
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Misconceptions about biosimilars include doubts about their safety, efficacy, and risks associated with switching from reference biologics. Biosimilars extend beyond cost savings, improving access to essential treatments, especially in underserved populations. 2 Misconceptions About BiosimilarsBiosimilars are the same as generics.
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