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.
Study Documents HCPs’ Experiences of a Mandatory Switch to Inform Future Transitions
December 2nd 2023A survey explores the experiences of health care providers (HCP) throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in New Zealand in 2022.
Biosimilar Business Roundup for October 2023—Podcast Edition
November 5th 2023On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.
HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain
November 28th 2023Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
Biosimilars Regulatory Roundup for September 2023—Podcast Edition
October 1st 2023On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.
Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar
November 22nd 2023Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).
