News - Page 2

Biosimilar developer Sandoz today announced the launch of its biosimilar adalimumab, Hyrimoz, in Spain. The biosimilar, referencing Humira, was authorized for sale in the European Union in July 2018. 
A United States District Judge in New Jersey has allowed a proposed class-action lawsuit against 3 major insulin makers to proceed.
A study of cost trends for tumor necrosis factor (TNF) inhibitors for rheumatoid arthritis (RA) after the entry of new competition showed that the newer drugs did not lower costs, and in fact, the annual treatment costs of the existing medicines rose by $17,390. Taxpayer funds shouldered all of the increases, and the “findings illustrate a market failure contributing to the rising costs of prescription drugs,” according to the researchers.
Health Canada has announced that all biologics, including biosimilars, will be identified by their brand names and nonproprietary names without the addition of a product-specific suffix. The regulator says that both the brand name and nonproprietary name of any biologic product should be used at all times so that products that share the same nonproprietary name can be differentiated by their brands.
The comment period has recently closed for the FDA’s proposed approach to the transition of insulins and other products that have historically been regulated as drugs and follow-ons to regulation as biologics and biosimilars, and among the comments from stakeholders is a suggestion that one drug maker may be interested in selling biosimilars of its own products.
Originator and biosimilar anti–tumor necrosis factor (anti-TNF) therapies are widely used to treat inflammatory bowel disease (IBD) and are effective in reducing systemic inflammation and thereby reducing tissue damage. While these drugs have revolutionized the treatment of IBD, adverse events (AEs) related to these agents can cause morbidity and mortality, and gastroenterologists must be prepared to recognize and manage these AEs. A recently published review described AEs of particular concern with anti-TNFs and outlined their management.
After the Association for Accessible Medicines’ (AAM’s) Access! 2019 annual meeting came to a close last week, The Center for Biosimilars® spoke with Christine Simmon, senior vice president of policy and strategic alliances, AAM, and executive director, AAM’s Biosimilars Council, to get her take on some of the outcomes of the meeting.
The FDA released draft industry guidance for its pathway aimed at providing incentives to stimulate competition for branded drugs that have few or no generic counterparts in the marketplace. Separately, it also updated its “name and shame” list.
The United Kingdom’s National Institute for Health and Care Excellence (NICE) today released a final appraisal of pertuzumab (Perjeta) together with intravenous trastuzumab and chemotherapy for the treatment of HER2-positive early breast cancer, and recommended pertuzumab for use in patients if they have lymph node–positive disease and if drug maker Roche adheres to its promised discount for the drug.
Even as developers begin work on the next wave of cost-saving biosimilars, and though approximately 50 biosimilar products (including monoclonal antibodies) have been approved in Russia to date, the country has not yet established clear regulatory guidelines for biosimilars.

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