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The Top 5 Biosimilars Articles for the Week of January 29
The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 29, 2018.
Transcript:
Hi, I’m Kelly Davio 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 January 29.
Number 5: At this week’s swearing-in ceremony for Alex Azar, the new Secretary of HHS, President Donald Trump promised that the price of prescription drugs will “come rocketing down” under Azar’s leadership.
Number 4: Celltrion, maker of the biosimilar infliximab product Inflectra, has received a new warning letter from the FDA.
Number 3: A new drug pricing forecast from the consulting company Vizient suggests that biosimilars have reached a tipping point in the US marketplace.
Number 2: The Biosimilars Council has filed an amicus brief in an ongoing case brought by Pfizer against Johnson & Johnson.
Number 1: SB3, a proposed trastuzumab biosimilar developed by Samsung Bioepis, demonstrated equivalence with Herceptin, according to a new study appearing in the Journal of Clinical Oncology.
Finally, last week, our e-newsletter asked whether the FDA should release information from Complete Response Letters. To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
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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.
