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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.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
What Clinicians Need to Know About Using Biosimilars to Treat IBD
April 13th 2024A review article, intended to act as a guide for clinicians, summarizes the available infliximab and adalimumab biosimilars for treating inflammatory bowel disease (IBD) as well as others that are coming down the pipeline.
