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The Pandemic's Multilevel Effect on Patient AccessCoronavirus disease 2019 altered the workflow in all areas of the health care and life sciences industries, and the FDA was not exempt from pandemic-induced upheaval.
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AmerisourceBergen Rep Previews the Year Ahead for Biosimilars: What’s Coming Down the Pipeline in 2022?Sean McGowan, senior director of Biosimilars for AmerisourceBergen, forecasts potential biosimilar approvals and launches in 2022 as well as offers insights into how emerging biosimilars will impact the market and pricing in the coming years during an interview.
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Understanding the Risks, Opportunities, and Prospects of Biosimilars in 2020 and BeyondHurdles to a vibrant biosimilar market are not as insurmountable as they appear.
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Australian Patients With IBD Switched to Biosimilar Infliximab Maintain Long-Term PersistenceLong-term data from the SAME study confirm that switching to infliximab biosimilars is safe and effective for patients with inflammatory bowel disease (IBD).
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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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Omalizumab Biosimilar Matches Reference Product in Chronic Spontaneous UrticariaCT-P39, an omalizumab biosimilar, shows comparable efficacy and safety to the original in treating chronic spontaneous urticaria, enhancing patient access.
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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.
