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The Top 5 Biosimilars Articles for the Week of May 21
The Center for Biosimilars® recaps the top 5 articles for the week of May 21, 2018.
Transcript:
Hi, I’m Kelly Davio 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 May 21.
Number 5: Both a disease activity score in a count of 28 joints and a score on a short-form mental health survey may be able to predict which patients with rheumatoid arthritis will experience a disease flare if they try to taper their anti—tumor necrosis factor therapy.
Number 4: The FDA has released a new series of educational videos on biosimilars and interchangeable products.
Number 3: At this week’s International Society for Pharmacoeconomics and Outcomes Research’s (or ISPOR’s) 23rd Annual International Meeting, researchers reported that, while biosimilars have a longer history in Europe than they have in the United States, challenges to uptake still linger.
Number 2: In a Monday workshop at the ISPOR meeting, Mike Blum, MD, MPH, of the FDA, addressed the role of postmarketing surveillance in the US biosimilars market.
Number 1: The European Commission has granted marketing authorization to Sandoz’s infliximab biosimilar, Zessly.
Finally, last week, our e-newsletter asked whether you think that the President’s drug pricing plan goes far enough to address Americans’ concerns over the high cost of healthcare.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars
December 10th 2024The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.
Denosumab Biosimilars Earn Positive CHMP Opinion for Bone Loss and Giant Cell Tumor of Bone
November 26th 2024The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the denosumab biosimilars SB16 for all indications referencing Prolia and Xgeva.
The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars
November 25th 2024Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.
