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The Top 5 Biosimilars Articles for the Week of May 14
The Center for Biosimilars® recaps the top 5 articles for the week of May 14, 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 May 14.
Number 5: The President’s plan to reduce drug prices for Americans includes asking FDA to issue guidance on possible abuse of safety programs to delay generic or biosimilar competition.
Number 4: Pfenex has announced positive top-line results from a phase 3 study of its follow-on teriparatide, referencing Forteo, a recombinant human parathyroid hormone.
Number 3: A study of pregnant patients treated with biosimilar infliximab for inflammatory bowel disease found that the biosimilar was not associated with any new safety concerns.
Number 2: CMS has released updated versions of its Drug Spending Dashboards, and data included show that prices are on the rise for drugs that have existing or upcoming biosimilar competition.
Number 1: The FDA has approved Pfizer’s epoetin alfa biosimilar, Retacrit, which the company is preparing to launch in 2018.
Finally, last week, our e-newsletter asked for your thoughts on which approach to biosimilar education is likely to have the biggest impact.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
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.
The Top 5 Most-Read Policy Articles of 2024
December 28th 2024The top biosimilar policy articles of 2024 highlight advancements that include FDA guidance to simplify biosimilar interchangeability and CMS drug price negotiations under the Inflation Reduction Act, alongside challenges posed by pharmacy benefit manager rebate practices and the need for more active stakeholder engagement.
How Vertical Integration Drives Innovation and Access in Biosimilars
December 27th 2024Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.
