Here are the top 5 biosimilar articles for the week of February 12, 2024.
Number 5: Etanercept biosimilar SB4 is just as effective as the originator drug (Enbrel) in treating Australian patients with rheumatoid arthritis (RA), leading to significant cost savings.
Number 4: The authors of a meta-analysis assessing several disease states found no significant differences in serious adverse events, deaths, or treatment discontinuations between patients who switched from reference products to biosimilars and those who did not.
Number 3: Vizient’s most recent Pharmacy Market Outlook report showcased the success of biosimilars while also emphasizing the impact of inflation on different drug classes, particularly in oncology and immunology.
Number 2: Since January 31, 2023, the United States has seen a boom in the adalimumab market. With 9 adalimumab biosimilars launching throughout the year, the US rheumatology, immunology, dermatology, and gastroenterology treatment spaces have a wealth of newer and cheaper alternatives to Humira (reference adalimumab).
Number 1: In his latest column, Sarfaraz K. Niazi, PhD, highlights challenges in biosimilar development, emphasizing the crucial role of US Pharmacopeia (USP) and advocating for collaboration and standardized guidelines to expedite cost-effective development without compromising safety or efficacy.
To read all of these articles and more, visit centerforbiosimilars.com.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
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.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.