A victory for Amgen and a defeat for Sandoz pushes biosimilar competition in the etanercept market out to 2029 unless Sandoz or Samsung Bioepis can eke out headway against Enbrel's patent wall.
India's medical authorities approve Biocon Biologic's itolizumab, an anti-CD6 IgG1 monoclonal antibody, for emergency treatment of cytokine release syndrome in patients with coronavirus disease 2019 (COVID-19).
Now is the time for the FDA to lead again in revising the biosimilar development guidance by eliminating all animal toxicology studies, and replacing them with larger-species pharmacokinetic (PK) studies, allowing the conduct of human PK studies using novel clinical protocols to combine the PK/pharmacodynamic/immunogenicity testing in a single study, and, where possible, avoid these studies if an in-silico approach can provide the confidence of pharmacologic similarity.
With a couple of recent biosimilar approvals, the FDA has vastly improved on the pace from the first 5 months of this year, during which no biosimilars were approved.
The FDA has approved Fujifilm Kyowa Kirin Biologics's Hulio adalimumab biosimilar, making it the sixth adalimumab biosimilar approved in the United States. However, none will be launched before 2023 because of the strength of AbbVie's exclusivity rights for Humira, the reference product. Hulio launched in Europe in 2018.
Slow growth of use of biosimilar infliximab in a Medicare fee-for-service population suggests lingering hesitancy on the part of gastroenterologists and patients, particularly when it comes to extrapolation to off-label uses, according to a new study.  
A review laid out ways for nurses to address patients’ questions on biosimilars in order to help them take on the role of improving utilization rates in cancer treatment.
Wayne Winegarden, PhD, director of the Center for Medical Economics and Innovation, explains that misaligned incentives are preventing the United States from realizing full benefit from biosimilars.
Cardinal Health Specialty Solutions has produced a Rheumatology Insights report that includes results from a survey of over 100 US-based rheumatologists on their perceptions and experiences with biosimilars in rheumatology thus far.
The widespread adoption of telemedicine during the coronavirus disease 2019 (COVID-19) pandemic, as well as reimbursement parity that was enacted by CMS, should be continued once the public health emergency passes, according to a new position statement by the American College of Rheumatology (ACR).

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