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The Top 5 Biosimilars Articles for the Week of April 30
The Center for Biosimilars® recaps the top 5 articles for the week of April 30, 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 April 30.
Number 5: Real-world evidence shows that biosimilar filgrastim has the potential to improve access to febrile neutropenia prophylaxis.
Number 4: A session at the Academy of Managed Care Pharmacy’s Managed Care & Specialty Pharmacy Annual Meeting in Boston, Massachusetts, provided an in-depth look at state legislation on biosimilars.
Number 3: Biosimilar developer Biocon has been issued a new Form 483 noting observations from an FDA inspection of its Bangalore manufacturing facility.
Number 2: Celltrion’s trastuzumab biosimilar, Herzuma, has launched in Europe, making it the second biosimilar referencing Herceptin to become available in the European marketplace.
Number 1: The FDA has issued a Complete Response Letter for Sandoz’s proposed rituximab biosimilar.
Finally, last week, our e-newsletter asked whether you think that physician education on biosimilars will improve as more products come to market.
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.
