Authors
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Contributor: The Trouble With IP for Digital Health and Precision MedicineTwo experts in biosimilar intellectual property (IP) law break down the issues that digital health and precision medicine face with IP and the history of case law that has created the current landscape.
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Americans Say Drug Costs Are Too High, and They Are RightThe executive director of the Biosimilars Forum calls for policies to support adoption of lower-cost biologics.
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Why Are Companies Launching Biosimilars With 2 Prices? Julie Reed ExplainsWhy are companies pricing their adalimumab biosimilars with 2 prices? Can the United States expect more of this pricing strategy for future biosimilar launches? Julie Reed, executive director of the Biosimilars Forum, has the answers.
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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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Opinion: The Inflation Reduction Act is a Step Backward for Biosimilar CompetitionIn response to another opinion piece, Craig Burton, from the Association for Accessible Medicines, argued that the Inflation Reduction Act of 2022 could prevent biosimilar competition, and lower drug prices as a result.
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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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HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending RemainAlthough biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
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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.
