Biosimilars
What are biosimilars? The Pharmacy Times® Biosimilars resource center keeps those in the space up to date with the latest clinical news and articles, coverage from conferences and meetings, links to condition-specific resources, and videos and other content.
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Pfizer will become the first to launch 3 oncology monoclonal antibody biosimilar treatments to the US market.
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Biosimilars, which at the most simplistic level can be thought of as a type of generic option for a biologic, offer an opportunity to help reduce total biologic drug spend.
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Trastuzumab-dkst (Ogivri, Mylan, Biocon), a biosimilar to trastuzumab (Herceptin, Genentech Inc.), has been launched in the US, according to an announcement from Mylan N.V. and Biocon Ltd. It is the first biosimilar approved by the FDA and recommended by the FDA Oncologic Drugs Advisory Committee.
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Officials with the FDA have approved adalimumab-afzb (Abrilada, Pfizer), a biosimilar to Humira, for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis.
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Top news of the day from across the health care landscape
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Ron Lanton III, Esq., discusses the specialty pharmacist's role in educating patients about biosimilars and biologics.
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Ron Lanton III, Esq., discusses challenges in launching biosimilars after they've been approved.
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The first oncology therapeutic biosimilars are now available in the United States.
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Amgen’s ABP 501 (Amjevita) shows similar efficacy to the reference adalimumab (Humira) in treating rheumatoid arthritis and supported approval of the biosimilar by the FDA.
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Lawsuit alleges that patients paid artificially high prices for brand-name Humira, and that they were deprived of the benefits of early, robust competition from biosimilars as a result of wrongful conduct.
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Rituximab is approved by the FDA for the treatment of adults with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
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Biosimilars present a cost-saving opportunity for the health care system, but significant challenges inhibit uptake in the US market.