The Center for Biosimilars® recaps the top stories for the week of March 30, 2020.
Hi, I’m Skylar Jeremias 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 March 30, 2020.
Number 5: According to a patent attorney, life under the new biologics pathway will be easier for some drugs than others.
Number 4: According to a study in The American Journal of Managed Care, when providers get used to biosimilars, they tend to prescribe them exclusively.
Number 3: Mylan and Lupin have gained the necessary recommendation to begin marketing their etanercept biosimilar in Europe.
Number 2: Two doctors call for interchangeability requirements for biologics to be waived for insulin products under the new regulatory pathway under the Biologics Price Competition and Innovation Act (BPCIA) of 2009.
Number 1: Teva Pharmaceuticals USA has filed suit in an attempt to use the expanded biologics licensure pathway as a way to hold back a potential competitor.
To read all of these articles and more, visit 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.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
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.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
BioRationality: Should mRNA Copies Be Filed as NDAs or Biosimilars?
November 4th 2024The article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products could be reconsidered, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
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