Here are the top 5 biosimilar articles for the week of September 18, 2023.
Hi, I’m Justina Petrullo 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 18th, 2023.
Number 5: Study results suggested an association between antidrug antibodies and nonresponse to biologic disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA).
Number 4: Although removing the requirement for clinical efficacy testing for biosimilar approval would reduce development costs of biosimilars, representatives from several biosimilar manufacturers argued in the second day of the FDA’s development workshop that clinical outcomes will not be affected.
Number 3: A report from the Association for Accessible Medicines (AAM) highlighted the value of biosimilars and generics, revealing that lower-cost versions of originator products accumulated $408 billion for the US health care system in 2022.
Number 2: Growing use of innovator biologics, including those with biosimilar competition, has led to increased Medicare Part B drug expenditures, with the trend unlikely to stop.
Number 1: An FDA workshop featuring regulators from around the world provided the regulatory perspective on how each government determines whether a biosimilar is clinically equivalent to their reference product, highlighting the science behind their development guidelines.
To read all of these articles and more, visit centerforbiosimilars.com.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Etanercept Biosimilar Switch Shows Stable Outcomes and Disease Control in RA
May 13th 2025Patients with rheumatoid arthritis (RA) who switched from Enbrel (reference etanercept) to a biosimilar maintained remission, even after their dose was reduced, with no signs of worsening based on clinical scores, ultrasound scans, or lab tests, according to a new study.
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?
Switching From Avastin to Bevacizumab-bvzr in CRC, NSCLC Can Reduce Medicare Costs
May 10th 2025Monthly savings from fully converting Medicare patients with metastatic colorectal cancer (CRC) and non-squamous metastatic non-small cell lung cancer (NSCLC) from reference bevacizumab to bevacizumab-bvzr could fund 13,887 and 8,959 additional patient-months of treatment, respectively, according to a cost-effectiveness study.