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The Top 5 Biosimilar Articles for the Week of February 22
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 February 22, 2021.
Number 5: Coherus BioSciences reported that the FDA has accepted for review its biologics license application (BLA) for an adalimumab biosimilar (CHS-1420), but did not specify the formulation concentration.
Number 4: Frontline use of rituximab biosimilars plus chemotherapy in patients with follicular lymphoma (FL) is more costly than a regimen of obinutuzumab (Gazyva) plus chemotherapy, investigators reported, based on a decision-analytic modeling study.
Number 3: Fresenius Kabi, a Germany-based biopharmaceutical company with global operations, mapped out an ambitious biosimilar launch program as it released earnings data.
Number 2: Fresenius Kabi has launched an adalimumab injectable biosimilar (Idacio) in Canada. The launch is the second adalimumab launch in a week, right after Sandoz’ launch of Hyrimoz.
Number 1: Gary H. Lyman, MD, PhD, provides an expert overview on overcoming the challenges of discussing biosimilars with patients.
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.
