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The Top 5 Biosimilar Articles for the Week of January 11
Here are the top 5 biosimilar articles for the week of January 11, 2021.
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 biosimilar articles for the week of January 11, 2021.
Number 5: Rapid health care reforms in China have led to a regulatory environment that improves conditions for biosimilar development and approval, according to Lawrence A. Hill, PharmD, MBA, RPh, BCPS, CEO of Gan & Lee Pharmaceuticals
Number 4: Authors of a review of studies on machine learning speculated that artificial intelligence could improve the selection of biosimilars for therapy.
Number 3: Investigators have reported pharmacokinetic (PK) findings that confirm the biosimilarity of Viatris’ trastuzumab biosimilar candidate (Ogivri) to reference Herceptin.
Number 2: Authors of a review found that biosimilar uptake and market share are not in themselves sufficient to establish whether these agents will lead to savings.
Number 1: Multiple biosimilar developers have obtained FDA approval for adalimumab biosimilars but won’t be able to enter the market until 2023. One question on experts' minds is whether these approved biosimilars will still be relevant 2 years from now.
To read all of these articles and more, visit centerforbiosimilars.com.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
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.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
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.
