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Legal Opinion: BPCIA Is Likely to Survive Latest ACA ChallengeIntellectual property attorneys discuss the Supreme Court oral arguments over the Affordable Care Act (ACA) and implications for the Biologics Price Competition and Innovation Act (BPCIA).
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What's Ahead for Biosimilar Litigation?What is ahead for biosimilar litigation? We highlight a recent interview Goodwin partners gave recently about their new guide to biosimilar litigation.
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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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Naming Biosimilars: The Debate Rages OnAs one of Shakespeare’s most famous characters asked, "What’s in a name?”, the answer in the biosimilars industry is clear: nomenclature is critical for identification purposes.
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Study Finds ABP 215 and Bevacizumab Demonstrate PK Similarity in Japanese MenThe researchers say that their data were consistent with the pharmacokinetic equivalence previously demonstrated in a single-dose PK study that included 202 healthy adult men in the United States and European Union, and thus add to the evidence of ABP-215 as a high-quality biosimilar to bevacizumab for use in Japan.
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Expect Shakeout Amid Biosimilar Market GrowthThe biosimilar market is headed for a fork in the road, and the road taken will lead to savings and access or less competition and stiffer regulation.
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Patel: Biosimilar Education Can Be ChallengingKashyap B. Patel, MD, has worn many hats in the struggle to broaden biosimilar access. He is an independent oncology practitioner, a member of the Community Oncology Alliance (COA), and a representative of International Oncology Network (ION) Solutions, a large drug purchasing organization. Bringing biosimilars to a broader population of patients has involved negotiations with payers, persistence on Capitol Hill, and education, he explains in an interview.
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Gastroenterologists Want More Evidence on Nonmedical SwitchingAlthough the totality of the evidence is reassuring, the jury is still out on nonmedical switching to biosimilars, according to new study results.
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Election May Determine Pace of Biosimilar LegislationThere are several pending legislative proposals in both the House of Representatives and the Senate designed to encourage more commercialization of biosimilars, but the 2020 election may determine their timing.
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Legal Opinion: BPCIA Is Likely to Survive Latest ACA ChallengeIntellectual property attorneys discuss the Supreme Court oral arguments over the Affordable Care Act (ACA) and implications for the Biologics Price Competition and Innovation Act (BPCIA).
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Julie Reed On How the Biosimilars Forum is Helping FDA Catch Up on Biosimilar InspectionsJulie M. Reed, the executive director of the Biosimilars Forum, dives into the efforts that the Forum is taking to ensure that FDA can catch up on their inspections backlog and get biosimilar approvals back on track.
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Contributor: Self-Administered Biosimilars Are Coming Quickly—Is Your Clinic Ready?Four pharmacists offer advice for clinics on how to prepare for new self-administered biosimilar products, including adalimumab biosimilars, and overcome emerging administrative challenges.
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Opinion: How Will Semglee Interchangeable Insulin Affect Access and Affordability?The approval of Biocon Biologics and Viatris' insulin glargine product as an interchangeable biosimilar will be a test of whether such designations can make a difference in patient access, Jeff Baldetti, MBA, of Cardinal Health explains.
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Opinion: The Legal and Regulatory Year in ReviewIntellectual property law attorneys from Axinn discuss regulatory and legal events in 2020 that will affect biosimilar markets in 2021.
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What We Learned About Biologics on Summer VacationIntellectual property law attorneys from the Washington, DC, offices of McDermott Will & Emery LLP, discuss 5 of the most significant trends in biologics litigation that have emerged in recent months.
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Contributor: Self-Administered Biosimilars Are Coming Quickly—Is Your Clinic Ready?Four pharmacists offer advice for clinics on how to prepare for new self-administered biosimilar products, including adalimumab biosimilars, and overcome emerging administrative challenges.
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Opinion: Biosimilars Offer Savings and Access for US PatientsIn this column, officials from the Biosimilars Forum and Xcenda discuss how biosimilar competition has lowered prices of originator biologics and improved patient access.
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Contributor: No Good Deed Goes Unpunished—How PBM Mandates Increase Practice VariabilityJeff Patton, MD, CEO and board member at OneOncology, dived into the controversial role that pharmacy benefit managers (PBMs) play in formulary decision-making and how PBMs impact biosimilar utilization.
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Budget Impact Analysis of Biosimilar Natalizumab in the USProjected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
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What We Learned About Biologics on Summer VacationIntellectual property law attorneys from the Washington, DC, offices of McDermott Will & Emery LLP, discuss 5 of the most significant trends in biologics litigation that have emerged in recent months.
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Budget Impact Analysis of Biosimilar Natalizumab in the USProjected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
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Dr Ivo Abraham Column: Not All Quiet on the Biologics Front—Biosimilars, Biobetters, and BioparallelsIn his comeback column, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, explores the world of biobetters and the complicated dynamics surrounding the FDA approval of Zymfentra, the first subcutaneous infliximab.
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The Growth of Biosimilars Continues to Create Hope for Lower Drug CostsPerhaps the most significant development in the pharmaceutical industry in decades, crops of biosimilars are being approved and are ready for distribution. What lies next, in terms of legislation and the impact on pharmacists, remains to be seen.
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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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Opinion: Biosimilars Offer Savings and Access for US PatientsIn this column, officials from the Biosimilars Forum and Xcenda discuss how biosimilar competition has lowered prices of originator biologics and improved patient access.
