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The Top 5 Biosimilars Articles for the Week of March 25
The Center for Biosimilars® recaps the top news for the week of March 25, 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 25.
Number 5: The FDA's updated guidance on the naming of biologics has caused concern among some proponents of biosimilars, and one stakeholder has now filed a citizen petition with the FDA in which he asks that the guidance be withdrawn.
Number 4: Roche has reached a confidential US patent settlement with Pfizer regarding its brand-name rituximab, Rituxan.
Number 3: Spectrum Pharmaceuticals has withdrawn its Biologics License Application for a novel granulocyte colony-stimulating factor therapy that the company had hoped to sell under the brand name Rolontis.
Number 2: The Department of Justice has issued a letter saying that the Affordable Care Act should indeed be struck down, raising questions about the future of the biosimilar approval pathway.
Number 1: A research letter published this week shows that biosimilars of insulin can generate significant cost savings.
Finally, last week, our e-newsletter asked which policy proposal recently put forward by the Trump administration would most encourage biosimilars.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
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.
Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data
November 19th 2024The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
Breaking Down Biosimilar Barriers: Interchangeability
November 14th 2024Part 3 of this series for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility.
