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The Top 5 Biosimilars Articles for the Week of February 12
The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 12, 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 February 12.
Number 5: On the same day that the President released his budget proposal that called for $2 billion less in funding for the National Institutes of Health than allocated by Congress, a new paper argued that a reduction in funding would significantly delay the emergence of new drugs.
Number 4: Roche has released phase 2 data for a novel drug that could compete with biosimilars of anti-vascular endothelial growth factor therapies.
Number 3: The White House’s Council of Economic Advisors said in a new white paper that the FDA should finalize biosimilar interchangeability guidelines that are easy and inexpensive to adhere to in order to promote competition.
Number 2: South Dakota became the latest state to pass legislation governing the substitution of interchangeable biosimilars for their reference products.
Number 1: Celltrion has received authorization to market its biosimilar trastuzumab, Herzuma, in the European Union.
Also this week, attorneys George Yu and Christopher Bruno, both of Schiff Hardin, explained how the Supreme Court’s eventual decision in the ongoing Oil States case could affect the biologics industry.
Finally, last week, our e-newsletter asked whether the United States should follow Australia’s lead by not using 4-letter suffixes in the names of biosimilars and biologics.
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.
