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Number 4: The FDA has released new draft guidance for industry on good practices for submitting abbreviated new drug applications to speed generic drug approvals.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.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
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.
Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data
November 19th 2024The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
Breaking Down Biosimilar Barriers: Interchangeability
November 14th 2024Part 3 of this series for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility.