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The Top 5 Biosimilars Articles for the Week of January 1
The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 1, 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 1.
Number 5: Many pharma companies rang in the new year with increases to their drugs’ list prices.
Number 4: The FDA has released new draft guidance for industry on good practices for submitting abbreviated new drug applications to speed generic drug approvals.
Number 3: New data show that LG Chem’s proposed biosimilar etanercept matches the reference Enbrel in terms of safety and efficacy.
Number 2: Drug maker Protalix announced positive phase 2 clinical data for an orally administered anti-TNF therapy.
Number 1: Momenta and Mylan have announced that they will begin clinical trials of M710, a proposed biosimilar to Eylea.
Finally, this week, contributor Brian Lehman explains why the so-called Medicare Part D “donut hole” creates an unintentional barrier to biosimilars in the United States. Read Lehman’s article and more content from expert contributors at centerforbiosimilars.com.
Eye on Pharma: Korean Drugmakers’ Impact in Europe; New Denosumab, Eculizumab Deals
January 11th 2025Korean drugmakers hold over 50% market share in the 6 best-selling biosimilar markets, 2 companies sign exclusive licensing partnership for a denosumab biosimilar, and 2 others join forces for an eculizumab biosimilar.
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.
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.
