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The Top 5 Biosimilar Articles for the Week of December 12
Here are the top 5 biosimilar articles for the week of December 12, 2022.
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 December 12, 2022.
Number 5: In his newest column installment, Sarfaraz K. Niazi, PhD, looked into the domestic and international support for removing interchangeability for biosimilars in the United States.
Number 4: The Accreditation Council for Medical Affairs (ACMA) is launching a new program for health care professionals to become Board Certified Biologics and Biosimilars Specialists.
Number 3: Prime Therapeutics has officially acquired Magellan Rx Management, a popular pharmacy benefit manager (PBM) in the specialty pharmacy space.
Number 2: The FDA has accepted Biogen’s biologics license application for a tocilizumab biosimilar candidate (BIIB800) referencing Actemra for review.
Number 1: Following their initial European launch of the drug, Alvotech and STADA Arzneimittel launched their adalimumab biosimilar referencing Humira in 7 more European countries: Belgium, Bulgaria, Croatia, the Czech Republic, Latvia, Romania, and Slovenia.
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.
