This week, the American College of Rheumatology (ACR) released a new position statement on the importance of pharmacovigilance and the critical need to continue monitoring new drugs after they reach the market.
This week, the American College of Rheumatology (ACR) released a new position statement on the importance of pharmacovigilance and the critical need to continue monitoring new drugs after they reach the market.
In a statement, the organization stressed that, with the development and introduction of biosimilars in the rheumatology clinic, the need for both the detection and reporting of adverse events (AEs) is vital. This fact is particularly due to the complex manufacturing process of biosimilars, and the difference in AEs that could theoretically be possible between the biosimilar or reference product.
To ensure the continued monitoring of drugs, ACR supports 5 key positions:
ACR stresses the importance of pharmacovigilance not only at the national level, but the international level as well. The United States participates in a pharmacovigilance program developed by the World Health Organization called the Program for International Drug Monitoring. As of 2016, 127 countries were included in the program.
“Most new medications are approved for marketing after only a limited period of testing on a relatively small group of patients,” said Donald Miller, PharmD, FASHP, co-author of the position statement, in a prepared comment.
“This statement puts us on record of supporting prompt reporting of new and unexpected side effects to the FDA and advocating for more comprehensive systems to observe drug safety in practice.”
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
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.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.