Here are the top 5 biosimilar articles for the week of January 31, 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 January 31, 2022.
Number 5: Two new studies investigated Imraldi (SB5), an adalimumab biosimilar developed by Samsung Bioepis, in inflammatory bowel disease (IBD).
Number 4: The Biosimilars Forum has appointed Cofounder and President Juliana (Julie) M. Reed, as the new executive director. Reed shared some of her goals for the Biosimilars Forum in an interview with The Center for Biosimilars®.
Number 3: After increasing its ownership stake in Samsung Bioepis from 15% to 50% in 2018, Biogen is now selling it for up to $2.3 billion.
Number 2: Three studies from the Indian Institute of Technology in Delhi laid out the biosimilar approval guidelines and market growth projections for several countries in the Asia Pacific region, Latin America, the Middle East and Africa.
Number 1: US biosimilar uptake faces several barriers, including misconceptions regarding biosimilar efficacy and a misalignment of prescription incentives between payers, providers, and patients, panelists discussed.
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.