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The Top 5 Biosimilars Articles for the Week of April 22
The Center for Biosimilars® recaps the top news for the week of April 22, 2019.
Transcript:
Hi, I’m Samantha DiGrande 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 April 22.
Number 5: The FDA has granted priority review to Novartis’ innovator biologic, brolucizumab, which outperformed aflibercept in some secondary study endpoints.
Number 4: Xbrane Biopharma, a Swedish biotechnology company, says it is starting its phase 3 trial of its ranibizumab biosimilar, and set sales targets for the drug.
Number 3: A new paper explains that disparities in access to biologics are still frequent in Europe, but biosimilars could help.
Number 2: A new survey revealed managed care and specialty pharmacy professionals’ perceptions about overcoming challenges to biosimilars.
Number 1: As biosimilars begin to gain ground in Canada, Janssen has launched a program that it says will offer patients brand-name biologics at prices similar to those of biosimilar options.
Finally, last week, our e-newsletter asked whether you think that an advocacy group’s recent recommendation (that patients who are being successfully treated should not be switched to biosimilars) is justified.
To view results of the poll, visit us on LinkedIn.
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.
