November 21st 2024
Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
Report: Conflicting Guidelines, Rebate Walls Are Major Factors Determining Biosimilar Uptake
October 24th 2023Samsung Bioepis’ most recent biosimilar market report identified inconsistent medical guidelines, challenges with access and rebates, and acute vs chronic treatment duration as major factors influencing biosimilar uptake in the United States.
Varying Biosimilar Policies Create Uneven Market Sustainability Across Nations
October 12th 2023An international comparative analysis found that the level of biosimilar market sustainability differs between countries, largely due to variances in biosimilar policies and years of experience managing a biosimilar market.
Patient Surveys Provide Insight Into Real-World Adalimumab Biosimilar Use in IBD
September 19th 2023A study evaluating the real-world impact of treating patients with inflammatory bowel disease (IBD) with an adalimumab biosimilar found that providing patient questionnaires early can be useful for identifying those at a higher risk of treatment discontinuation.
Part 1: FDA Workshop Highlights Global Regulatory View on Biosimilar Development
September 13th 2023An 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.
AAM Report: Generics and Biosimilars Generate $408 Billion in 2022
September 12th 2023A 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.
The Growth of Biosimilars Continues to Create Hope for Lower Drug Costs
September 7th 2023Perhaps the most significant development in the pharmaceutical industry in decades, crops of biosimilars are being approved and are ready for distribution. What lies next, in terms of legislation and the impact on pharmacists, remains to be seen.
Higher Risk of Discontinuation During Biosimilar Switching Found Among Women
September 5th 2023Switching from reference to biosimilar adalimumab was found to be safe and effective. Researchers cautioned that female patients may be at higher risk of discontinuation compared with their male counterparts.
Meta-Analysis Confirms Clinical Equivalence Between RA Biosimilars, Originators
August 26th 2023A meta-analysis and systematic review of data on over 10,000 patients with rheumatoid arthritis (RA) found that etanercept, adalimumab, and infliximab biosimilars were clinically equivalent to their reference products.
Contributor: The Promise of RA Biosimilars Could Be Realized, but Greater Adoption Rates Are Needed
August 14th 2023Robert Zutaut, RPh, a clinical specialist from McKesson Provider Solutions, quantifies the major barriers to adoption for biosimilars used to treat rheumatoid arthritis (RA) and some major considerations for health systems looking to address them.
Spanish Psoriasis Working Group Revises Guidelines for Biosimilars in Psoriasis
August 10th 2023The Spanish Psoriasis Working Group updated its position on the use of biosimilar medicines in patients with moderate to severe psoriasis, including its views on biosimilars as first-line treatment and nonmedical switching.
Sintilimab Plus Bevacizumab Biosimilar vs Avastin Is Cost-Effective in HCC
August 8th 2023A Chinese study proved that combination therapy with sintilimab and a bevacizumab biosimilar was cost-effective enough in patients with hepatocellular carcinoma (HCC) to warrant use of the biosimilar over the reference product (Avastin) without compromising safety or efficacy.
Biosimilar Business News Recap: 3 Biosimilar Application Submissions; Roche Sues Biogen
July 26th 2023Formycon and Celltrion announced the FDA submissions for their aflibercept biosimilars; the European Medicines Agency accepted a marketing authorization application for an ustekinumab biosimilar; and Roche filed suit against Biogen over a tocilizumab biosimilar.
AAM White Paper Breaks Down Drug Shortage Crisis: Causes and Solutions
July 25th 2023The Association for Accessible Medicines (AAM) published a white paper on the impact that ongoing drug shortages have had on the generic and biosimilar industries as well as possible solutions stakeholders can put into action.
The Age of Adalimumab Is Upon Us: How Stakeholders Can Prepare
June 28th 2023The Center for Biosimilars® provides an updated look on the adalimumab biosimilars that are coming down the US pipeline as well as what stakeholders need to know and how they can prepare ahead of the US launch of 8 adalimumab biosimilars in July 2023.
Dose Rounding Can Reduce Drug Waste Costs Associated With Reference, Biosimilar Bevacizumab
June 19th 2023Implementing strategies, such as dose rounding, can offset the impact of drug waste and reduce the total cost of care for value-based programs, according to a recent study of practices participating in the Oncology Care Model.