The AJMC® Biosimilars compendium is a comprehensive resource for news and expert insights into these biological products, including clinical research, patent and legal news, and regulatory updates.
April 12th 2024
Patients with radiographic axial spondyloarthritis (ax-SpA) and a high risk of radiographic progression had similar low progression on both secukinumab and an adalimumab biosimilar.
December 31st 2023
More Biosimilar Launches in 2020 Seen at AMCP
April 23rd 2020COVID-19 has affected the pace of clinical trials, and the FDA’s most recent notice has been that there will be no “near-term” affect on approvals, said Leslie Fish, RPh, PharmD, who co-presented with Jeffrey Casberg, MS, RPh, in Tuesday’s session, "Drug Pipeline: Traditional Pharmaceuticals and Bisoimilars," at AMCP eLearning Days, which replaced the annual meeting of the Academy of Managed Care Pharmacy.
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COVID-19 Upends Drug Purchasing Patterns, and More Disruption Likely, IQVIA Expert Says
April 20th 2020Douglas M. Long, MBA, vice president of industry relations for IQVIA, surveyed the effects of COVID-19 as he kicked off AMCP eLearning Days, a webinar series held in place of the annual meeting of the Academy of Managed Care Pharmacy (AMCP).
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Part 2: Cheryl Larson on Balancing Employer Needs, Controlling Cancer Costs, and Future Goals
April 19th 2020In the second part of a 2-part preview interview in advance of this year’s virtual 2020 Community Oncology Conference, The American Journal of Managed Care® speaks with Cheryl Larson, president and chief executive officer of the Midwest Business Group on Health, about how she is helping employer organizations navigate their pharmacy benefits managers and manage employee expectations.
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FDA, FTC Need to Strengthen Biosimilar Efforts, AHIP Says
April 18th 2020AHIP wants the FDA and FTC to streamline product approvals, clarify the regulations governing biosimilars, put a stop to attempts to discourage people from using biosimilars, and start educating providers and patients about the safety and efficacy of these products.
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Home Infusion Services for Part B Drugs in the Spotlight Amid COVID-19 Regulatory Changes
April 10th 2020The Community Oncology Alliance (COA) said it is worried that the safety of patients with cancer will be compromised if home infusion regulatory changes, brought about by the coronavirus disease 2019 (COVID-19) pandemic, expand; other groups support the changes, which affect Medicare patients using Part B drugs.
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Review Outlines Challenges of Integrating Biosimilars Into Clinical Practice
April 4th 2020The introduction of biosimilars in the US market brings along specific challenges to health system pharmacists, including formulary assessment, implementation, and education of patients and various health system stakeholders, according to a review published in Drugs In Context.
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This Week in Managed Care: March 27, 2020
March 28th 2020This week, the top managed care news includes a $2 trillion package to address economic damage from coronavirus heads to President Trump, a regulatory change could change the fortunes for biosimilars, and the world’s biggest cardiology meeting goes virtual.
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FDA Clears New Dose of Trastuzumab Biosimilar From Samsung Bioepis
March 25th 2020The FDA Tuesday cleared a new dose of Samsung Bioepis’ trastuzumab biosimilar Ontruzant, which is yet to be launched in the United States. The approval is for a 420-mg multidose vial of Ontruzant. The biosimilar was first approved as a 150-mg single-dose vial by the FDA in January 2019 across all indications for the reference product, Herceptin.
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The Patent Trial and Appeals Board delivered a setback to Gilead Sciences, rejecting its attempt to invalidate a pair of Truvada patents owned by the CDC; Merck is spinning off some businesses in order to focus on its oncology drug pembrolizumab, including its biosimilars operations; Republican and Democratic governors are worried that a proposed CMS fiscal accountability rule for Medicaid will reduce access to healthcare.
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PAPER OF THE WEEK: In 2002, Researchers Found Early Use of Etanercept Improved Quality of Life In RA
January 17th 2020As part of our anniversary celebration, today we launch “Paper of the Week,” which will look back at some of the most influential research articles and commentary that have appeared in The American Journal of Managed Care® over the past 25 years, and why they are important today.
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Dr Elaine Husni: Huge Savings With Biosimilars Have Not Manifested
November 12th 2019While biosimilars have brought down the cost of therapies, the savings are not quite as huge as providers may have been led to believe when biosimilars were initially under development, said Elaine Husni, MD, MPH, vice chair and director of the Arthritis and Musculoskeletal Center in the Orthopedic and Rheumatologic Institute at the Cleveland Clinic.
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