The Center for Biosimilars® recaps the top news for the week of January 14, 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 January 14.
Number 5: A recently published study found that shifting reimbursement of some Medicare Part B drugs to Medicare Part D could increase out-of-pocket spending for some Medicare beneficiaries.
Number 4: Two studies published earlier this month found that biosimilar infliximab, CT-P13, had positive safety and efficacy data when switching patients with inflammatory bowel disease to the biosimilar.
Number 3: The House Committee on Oversight and Reform has launched a wide-ranging investigation into prescription drug pricing in the United States.
Number 2: In an interview with The Center for Biosimilars®, partners at Goodwin explained the impact that biosimilar developers will feel from the ongoing government shutdown.
Number 1: A representative from Pfizer has confirmed to The Center for Biosimilars® that the company has terminated 5 of its preclinical biosimilar programs after the results of the company’s annual investment review.
Finally, last week, our e-newsletter asked if the current administration is doing enough to curb cost growth for pharmaceuticals.
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.