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The Top 5 Biosimilar Articles for the Week of November 4
Here are the top 5 biosimilar articles for the week of November 4, 2024.
Number 5: By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.
Number 4: An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
Number 3: A recent study found that the rising prevalence of inflammatory bowel disease (IBD), approaching 1% in Europe and North America, is accompanied by increasing healthcare costs due to shifts in care and higher hospitalization expenses, presenting challenges to sustainability and prompting strategies for personalized, cost-effective care.
Number 2: Panelists emphasized the need for transparency and policy reforms in pharmacy benefit management (PBM) to improve accessibility, affordability, and fair competition for adalimumab biosimilars.
Number 1: An article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products could be reconsidered, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.
To read all of these articles and more, visit centerforbiosimilars.com.
Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
February 25th 2025The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.
Will the FTC Be More PBM-Friendly Under A Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Resolution of Injection Site Reactions After Switching to Adalimumab Biosimilar
February 22nd 2025A 15-year-old girl with ulcerative colitis who developed injection site reactions to the adalimumab reference product was successfully switched to the biosimilar LBAL without recurrence of symptoms, demonstrating the safety and effectiveness of switching for medical reasons, likely due to an allergic reaction to an excipient in the originator.
Biosimilars in Action: Market Shifts, Legal Insights, and FDA Approvals
February 9th 2025In this episode of Not So Different, host Skylar Jeremias covers the latest biosimilar developments, including new FDA approvals, patent disputes, and biosimilar market trends shaping the health care landscape.
FDA, EMA Approve Second Pair of Denosumab Biosimilars
February 17th 2025The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' denosumab biosimilars, which will be marketed under different names depending on whether they will be used to treat osteoporosis or bone metastases.
Teriparatide Biosimilar Shows Comparable Efficacy to Reference Drug in Postmenopausal Osteoporosis
February 17th 2025Researchers treated postmenopausal women with osteoporosis with teriparatide biosimilar RGB-10, which improved their bone health measures and reduced fracture risk comparably to reference teriparatide.
