Here are the top 5 biosimilars articles for the week of June 22, 2020.
Hi, I’m Skylar Jeremias 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 22, 2020.
Number 5: Plaintiffs in a novel class-action lawsuit against AbbVie have until the end of June to try again to pursue their claims that the maker of the originator adalimumab (Humira) created a patent thicket that makes it nearly impossible for rivals to gain a foothold.
Number 4: Shanghai Henlius Biotech said a trial of its bevacizumab biosimilar candidate HLX04 met its primary end point of progression-free survival at 9 months in patients with metastatic colorectal cancer.
Number 3: A joint position statement on biosimilars for the treatment of inflammatory bowel disease sparked backlash and criticism over the recommendation against nonmedical switching from reference infliximab to a biosimilar.
Number 2: Studies on switching and retention for adalimumab and etanercept biosimilars yielded positive data, according to abstracts presented at the EULAR 2020 Congress, the virtual meeting of the European League Against Rheumatism.
Number 1: Eli Lilly gets FDA approval for a new formulation of insulin lispro and offers it at the out-of-pocket cap of $35 for a monthly supply for patients with or without insurance.
To read all of these articles and more, visit centerforbiosimilars.com.
Competitive Pricing in Biosimilars: How Adalimumab Could Shape the Industry
Published: October 29th 2024 | Updated: October 29th 2024Sophia Humphreys, PharmD, MHA, BCBBS, of Sutter Health notes that although initial adoption of adalimumab biosimilars remained low in 2023, competitive pricing pressures have already benefited patients and the health care sector.
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.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims
October 23rd 2024At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.