The Center for Biosimilars® recaps the top 5 articles for the week of July 23, 2018.
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 July 23.
Number 5: Six months after patients switched from reference infliximab to biosimilar infliximab, there was no meaningful increase in patients’ outpatient healthcare use, according to a new study.
Number 4: The Biosimilars Competition Act of 2018 has been introduced in the United States House of Representatives. The bill would require biologic and biosimilar drug manufacturers to report any agreements they enter into that may keep lower-cost drugs from reaching consumers.
Number 3: A little over a year after having received FDA authorization for its clinical program, Glenmark Pharmaceuticals has announced positive phase 1 data from a trial of its Xolair biosimilar.
Number 2: In an interview with The Center for Biosimilars®, executives from Pfizer discussed the state of the US biosimilars marketplace.
Number 1: In order to gather stakeholder input on the initiatives explained in the Biosimilar Action Plan unveiled by FDA Commissioner Scott Gottlieb, MD, last week, the FDA has announced that it will hold a public hearing on the plan in September.
Finally, last week, our e-newsletter asked whether the price point for Mylan’s pegfilgrastim biosimilar is low enough to spark uptake.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
Improving Biosimilar Access Through Global Regulatory Convergence
January 15th 2025Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.
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.
Senators Introduce Bipartisan Legislation to Protect Skinny Labeling
January 2nd 2025To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.