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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.
Empowering Vulnerable Populations: The Path to Equitable Biologic Therapy Access
December 22nd 2024Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.
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.
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.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
