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The Top 5 Biosimilars Articles for the Week of April 16
The Center for Biosimilars® recaps the top 5 biosimilars articles for the week of April 16, 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 16.
Number 5: A federal appeals court in Maryland ruled that a recently passed law targeting drug pricing is unconstitutional.
Number 4: The FDA has finalized its guidance on special protocol assessments, which allow product sponsors to meet with the agency to agree on the design and size of clinical trials.
Number 3: A newly published study shows that patients with ankylosing spondylitis who received coaching as part of a patient support program for adalimumab had better clinical outcomes.
Number 2: During a session at the 2018 Community Oncology Conference, hosted by the Community Oncology Alliance, Robert Rifkin, MD, highlighted opportunities and challenges associated with biosimilars.
Number 1: During a panel at the National Policy and Advocacy Summit on Biologics and Biosimilars, panelists discussed key barriers to accessing biologics and other innovative treatments.
Also this week, expert contributor Brian Lehman explained the implications of CMS’ new policy to lower the cost of biosimilars for some Medicare beneficiaries.
Finally, last week, our e-newsletter asked whether you think a 3-year timeline from biosimilar approval to patient switching is too slow.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
BioRationality: Commemorating the 15th Anniversary of the BPCIA
April 8th 2025Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Patients With IBD Maintain Therapy 2 Years Post Switching to Infliximab Biosimilar
March 23rd 2025People with inflammatory bowel disease (IBD) who switched to the infliximab biosimilar CT-P13 had higher treatment persistence (84% and 91%) than those new to infliximab (66% and 53%), with no new safety concerns.
