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COVID-19's Multifaceted Effect on BiosimilarsThe coronavirus disease 2019 (COVID-19) effect on the biosimilar industry will be deep and lasting, causing not just approval and launch delays but profound structural changes in how business is done.
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Another European Study Finds SB4 Tolerated by Most PatientsThe study follows others that have found that SB4 works well for the majority of patients who switched from the originator etanercept, Enbrel.
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Lupin Partners With Mylan on Etanercept BiosimilarLupin recently announced that it has entered into a partnership agreement with Mylan to commercialize its proposed etanercept (Enbrel) biosimilar.
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COVID-19's Multifaceted Effect on BiosimilarsThe coronavirus disease 2019 (COVID-19) effect on the biosimilar industry will be deep and lasting, causing not just approval and launch delays but profound structural changes in how business is done.
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FDA Issues Draft Guidance Aimed at Cutting Expenses for Biosimilar PK StudiesBiologics eat 51% of drug spending despite being 5% of prescriptions, but the FDA's new draft guidance hopes more competition can close that gap.
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Using Biosimilar Filgrastim May Lead to Shorter Hospitalization, Lower Cost in PBSC MobilizationUsing the biosimilar resulted in a significantly lower drug acquisition cost, at $533.40 in the biosimilar group versus $1261.90 in the reference group.
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Federal Perspective on the Biosimilar Influence on Drug CostsProviding an overview on where the healthcare reform debate is headed, Andrew Slavitt, former head of CMS, refined the discussion to highlight the potential for biosimilars to influence the rising costs of drug products.
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Resources for Patients and Providers on Adalimumab BiosimilarsExpert providers in inflammatory diseases provide additional resources on biosimilars and adalimumab biosimilar for patients and providers.
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PBMs Drive Up Drug Costs, Squeeze Out Generics and Biosimilars, FTC Report FindsA long-awaited report from the Federal Trade Commission (FTC) finds that vertical integration and consolidation have worked against consumers and independent pharmacies.
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Postmarketing Surveillance Data Reinforce Trastuzumab Biosimilar Safety in HER2+ Gastric CancerCT-P6 demonstrates strong efficacy and safety in HER2-positive advanced gastric cancer, achieving an 82% disease control rate in real-world settings.
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Opinion: Is the Ophthalmology Market Ready to Embrace Biosimilars?Samsung Bioepis has filed for FDA approval for a ranibizumab biosimilar candidate (SB11), and more ophthalmology biosimilars are in the pipeline.
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Opinion: Purple Book Patent Listings Are Only a First StepIntellectual property attorneys from Axinn discuss the limitations of the Purple Book patent disclosure requirements and the burden these impose on biosimilar developers.
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Biosimilar Nonmedical Switching Must Never Undermine Patient SafetyWhile managing costs is extremely important to physicians and their patients, achieving and maintaining disease control without increasing the risk of complications or toxicities must remain the primary goal in the treatment of chronic inflammatory diseases.
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Contributor: Drug Delivery Devices Help Originator Companies Retain Market ShareAmgen's Onpro autoinjector device for pegfilgrastim is a stunning example of how product differentiation via drug delivery devices can protect market share in the biologics market.
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Supportive Care in Oncology Therapy: Pegfilgrastim Biosimilars in the PipelinePegylated version (pegfilgrastim) Neulasta® is the more commonly prescribed agent, with a significantly longer half-life than its predecessor and is the preferred in patients receiving cancer chemotherapy.
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What Australia’s Experience Reveals About Biosimilar Adoption and PricingAustralia's biosimilar adoption significantly reduces biologic medicine costs, enhancing access while maintaining utilization amid tighter health care budgets.
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Webinar: Streamlining the Regulatory Process to Advance Access to BiosimilarsThis webinar celebrating Global Biosimilars Week was hosted by The Center for Biosimilars® in partnership with the International Generics and Biosimilars Association.
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Part D Beneficiaries May Pay More for Some Generics, Biosimilars Than Brand-Name DrugsMedicare Part D enrollees may actually pay more for some generic drugs than they would for their brand-name counterparts because of the Part D benefit, according to findings of a new study appearing in Health Affairs.
