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New Rule: Transition to BLA Pathway Is CompleteAs of today, the FDA has completed a 10-year process to bring a wider set of biologics under the biologics license pathway for approval.
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Drug Couponing: Better or Worse for Biosimilars?Payers will have to carefully mull limited options.
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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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Dr Andre Harvin Answers How Oncologists Can Work to Expand Access to BiosimilarsAndre Harvin, PharmD, executive director of pharmacy and oncology services at Cone Health, explains how oncologists can work with other stakeholders to expand access to biosimilars and how patients can work with providers and biosimilar manufacturers to address financial challenges.
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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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Achieving PFS in Advanced Gastric Cancer With HLX02 Biosimilar, ChemotherapyIn a phase 2 study, the addition of HLX22, an anti-HER2 antibody, to HLX02 biosimilar and XELOX (oxaliplatin and capecitabine) chemotherapy extended progression-free survival (PFS) in untreated HER2-positive advanced gastric cancer patients.
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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.
