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The Top 5 Biosimilars Articles for the Week of May 6
The Center for Biosimilars® recaps the top news for the week of May 6, 2019.
Transcript:
Hi, I’m Jaime Rosenberg 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 6.
Number 5: Last week, Coherus BioSciences announced that it has reached a settlement with Amgen over a trade secret case. Separately, Amgen filed a new complaint against Samsung Bioepis.
Number 4: The pan-Canadian Pharmaceutical Alliance and Cancer Care Ontario have partnered to create a new biosimilars initiative.
Number 3: Now that its comment period has closed, the FDA has heard from a variety of stakeholders who asked the agency to reconsider its guidance on biosimilar naming.
Number 2: A new review of the available literature on switching sought to address provider concerns about biosimilars.
Number 1: The idea of giving the Federal Trade Commission more authority to cut through patent thickets blocking biosimilar competition was raised during a hearing of the Senate Judiciary Committee.
Finally, last week, our e-newsletter asked whether you agree with a recent proposal that suggests regulating biologics’ prices rather than continuing to develop the US biosimilars market.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
Top 5 Most-Read Regulatory Articles of 2024
December 25th 2024In 2024, significant biosimilar approvals were granted by the American and European regulatory agencies, including the first interchangeability designations for biosimilars referencing ustekinumab, adalimumab, denosumab, and aflibercept, marking key regulatory milestones in improving patient access to cost-effective treatments.
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.
13 Strategies to Avoid the Nocebo Effect During Biosimilar Switching
December 18th 2024A systematic review identified 13 strategies, including patient and provider education, empathetic communication, and shared decision-making, to mitigate the nocebo effect in biosimilar switching, emphasizing the need for a multifaceted approach to improve patient perceptions and therapeutic outcomes.
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.
