Here are the top 5 biosimilar articles for the week of May 10, 2021.
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 biosimilar articles for the week of May 10, 2021.
Number 5: During a talk at the Medicines for Europe Biosimilar Medicines Conference, US and EU regulators discuss the potential for a tailored approach to bring biosimilars to market sooner with less expense and wasted effort.
Number 4: Pfizer doubles down on its pledge to fight rebates, and Organon executives discuss the growth potential of the planned Merck spinoff.
Number 3: Fighting back against a suit that alleges theft of trade secrets, Alvotech has filed suit against AbbVie alleging that key patents for its blockbuster adalimumab drug (Humira) should be invalidated partly on grounds that AbbVie did not invent the processes that were patented.
Number 2: This year marks the 15th anniversary of biosimilar availability in the European Union, and in an overview sponsored by Medicines for Europe, experts from regulatory and business venues discussed some of the major achievements and hurdles yet to be crossed.
Number 1: A deep dive into the anatomy of a biosimilar switching study reveals what it takes for a biosimilar to be approved as interchangeable in the United States.
To read all of these articles and more, visit centerforbiosimilars.com.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
FDA's Expanded Access: From Laetrile to Right to Try, Ethical Debates Over Early Drug Access
April 28th 2025Christopher T. Robertson, JD, PhD, reviewed the history and ethical landscape of providing access to drugs before FDA approval, highlighting the crucial role of clinical trials and ethical safeguards at the 2025 Festival of Biologics USA.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Addressing Patent Abuse, Reimbursement Models Key to Sustainable Biosimilar Market
April 25th 2025Sonia T. Oskouei, PharmD, emphasized strategies to streamline regulations and evolve to overcome barriers and expand the availability of cost-effective biosimilar treatments across more therapeutic areas.