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The Top 5 Biosimilars Articles for the Week of March 11
The Center for Biosimilars® recaps the top news for the week of March 11, 2019.
Transcript
Hi, I’m Samantha DiGrande for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
Here are the top 5 biosimilars articles for the week of March 11.
Number 5: A survey of health plan benefit sponsors representing employers found that most are using prior authorization or step therapy to encourage the use of biosimilars
Number 4: The Trump administration has released its proposed budget for the fiscal year 2020, and contained within it are a variety of proposals that impact biosimilars.
Number 3: Only 49% of prescribers in a recent European Society for Medical Oncology survey report using biosimilars in routine clinical practice.
Number 2: The FDA has issued a new Form 483 to Biocon over its Bangalore facility. The document makes 2 inspection observations that stem from inspections carried out in February 2019.
Number 1: The FDA has approved Pfizer’s trastuzumab biosimilar referencing Herceptin.
Finally, last week, our e-newsletter asked whether you think that concerns about the safety of Janus kinase inhibitors will make treatment for inflammatory diseases with biosimilars of anti—tumor necrosis factor therapies more appealing.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.
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.
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.
