Here are the top 5 biosimilar articles for the week of September 12, 2022.
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 September 12, 2022.
Number 5: As Alvotech’s biosimilars are included in a commercialization deal in the Philippines, the company hits a setback in its quest for FDA approval of its adalimumab biosimilar; the FDA gives EpiVax a $2 million grant to run immunogenicity testing for biosimilars.
Number 4: The second part of this 4-part series took a look at what patients and employers can expect when adalimumab biosimilars hit the market in 2023.
Number 3: As part of a larger series preparing for the US market entrance of adalimumab biosimilars in 2023, Steven Lucio, PharmD, BCPS, senior principal of pharmacy solutions at Vizient, makes predictions for how the rollout of these biosimilars may play out and offers advice to stakeholders for how to maintain a robust market.
Number 2: Celltrion Healthcare released positive data for an ustekinumab biosimilar, and Samsung Bioepis announced long-term safety and efficacy results for its adalimumab biosimilar.
Number 1: In a recent paper, Sarfaraz K. Niazi, PhD, argued that getting rid of clinical efficacy testing for biosimilars could realign testing ethics with current guidelines, save companies money on development, and improve data sensitivity.
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.