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The Top 5 Biosimilars Articles for the Week of June 11
The Center for Biosimilars® recaps the top 5 articles for the week of June 11, 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 June 11.
Number 5: HHS Secretary Alex Azar testified before the Senate Committee on Health, Education, Labor, and Pensions on the Trump administration’s blueprint to lower drug prices, but The American College of Rheumatology is raising concerns about some of HHS’s proposals.
Number 4: The FDA has announced the publication of 2 final guidance documents that seek to provide greater clarity on medical product communications.
Number 3: Research presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology, in Amsterdam, Netherlands, finds that, once patients are educated about biosimilars, most are willing to switch.
Number 2: The Senate Judiciary Committee voted 16 to 5 to report the CREATES Act to the Senate floor.
Number 1: Walgreen and Kroger have filed an antitrust suit against Johnson & Johnson and Janssen, alleging unlawful exclusion of biosimilar competition for infliximab.
Finally, last week, our e-newsletter asked whether the FDA’s approval of Fulphila will improve patient access to prophylaxis of febrile neutropenia.
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.
Health Canada Approves First Omalizumab Biosimilar
December 16th 2024Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.
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.
