Study Suggests Majority of Rituximab Use Is Off Label
The term “off-label” is described by the FDA as an unapproved use of an approved drug. Recently, a study conducted […]
Beijing 301 Hospital First to Dose Patient in Ankylosing Spondylitis Biosimilar Trial
A Chinese ankylosing spondylitis (AS) patient in China represents the first dosed patient in a Phase III clinical trial testing […]
Amgen and Allergen Submit Biologic License Application to U.S. FDA for ABP 798, Biosimilar Candidate to Rituxan® (rituximab)
Amgen and Allergan announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) […]
Lannett & Chinese Partner HEC Reveal Positive Phase I Results for Insulin Biosimilar Candidate vs. Lantus
Lannett Company (LCI) announced that the first human study evaluating insulin glargine, a long-acting insulin used to treat adults with […]
Why Does the U.S. Biosimilar Market Lag Behind Europe? Economic Consequences are Discussed
Biosimilar uptake in the United States lags behind Europe possibly causing the American health care consumer. A report published by […]
Brazilian Research Center Bio-Manguinhos in Deal With Bionovis & Samsung Bioepis to Bring Enbrel Biosimilar to the Country
Samsung Bioepis has received Brazilian Ministry of Health approval for Brenzys, an Enbrel biosimilar product. In Brazil, 90%+ of autoimmune […]
NHS Saving £300M by Instructing Providers to Not Prescribe Branded Drugs Including Humira
NHS Has Cut Its Drug Spend by 29%
China-based Bio-Thera Solutions Aggressively Developing Prominent Biosimilars
A Chinese biopharma company called Bio-Thera Solutions has begun the testing of its first batch of healthy volunteers to compare […]
Samsung Bioepis HUMIRA Biosimilar Approved in the U.S. & Will be Available in June 2023 Due to Patent Thicket
Samsung Bioepis Co. Ltd. reports that the U.S. FDA has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab) for the […]
South Korean Biotech Ready to Pounce on Japanese Biosimilar Market Despite Trade Tensions
South Korean biopharma companies, such as Chong Kun Dang and Dong-A ST, move to launch biosimilars in Japan despite some […]
