The Center for Biosimilars Staff

July 20, 2018

Catch up on the week’s top policy, clinical, business, regulatory, legal, and international news from the world of biosimilars.

July 18, 2018

The FDA has finalized its guidance on labeling of biosimilar products, and FDA Commissioner Scott Gottlieb, MD, called the finalized guidance "one of a suite of deliverables" that will be unveiled as part of the Biosimilars Action Plan.

July 06, 2018

Catch up on the week’s top rheumatology, gastroenterology, clinical practice, regulatory, policy, and business news from the world of biosimilars.

July 03, 2018

Intravenous administration of the anti–vascular endothelial growth factor treatment bevacizumab at high doses can result in serious, systemic adverse events (AEs). Additionally, tumors can become resistant to therapy and adopt a more invasive growth pattern. Thus, delivering bevacizumab for the treatment of cancer at a lower dose in a manner that avoids systemic AEs is necessary.

July 01, 2018

Eales disease (ED) is a common, idiopathic, inflammatory retinal vasculitis that particularly affects young adults. Current treatments available for ED include corticosteroids, laser photocoagulation, retinal cryotherapy, and surgery, but a recent study found that using intravitreal bevacizumab injections may produce better outcomes and reduce the need for surgery.

June 30, 2018

Primary sclerosing cholangitis (PSC) is a chronic, immune-mediated, progressive biliary disease that is closely associated with inflammatory bowel disease (IBD). PSC has no cure, and up to 40% of cases eventually require patients to receive liver transplants. Given the efficacy of biologics in treating IBD, the potential to treat PSC with these same drugs is a matter of interest for healthcare providers.

June 29, 2018

This month saw a variety of developments in the world of biosimilar drugs for the treatment of rheumatic diseases.

June 28, 2018

Intestinal Behçet disease (BD), which is an immune-mediated, chronic, inflammatory intestinal disease, can be difficult to treat, in part because the pathogenesis of intestinal BD is unclear. However, as data for using anti–tumor necrosis factor (anti-TNF) drugs have been accumulating in the treatment of inflammatory bowel disease (IBD), which has a similar clinical presentation, the potential to treat BD with these agents is under investigation.

June 21, 2018

Guidelines recommend that disease activity should be assessed every 1 to 3 months in patients with high or moderate disease activity, and every 6 to 12 months in those with low disease activity or remission, but implementation of these principles has not been well evaluated in the United States.

June 20, 2018

Anti–tumor necrosis factor (TNF) agents, widely used in rheumatology and gastroenterology, carry some safety risks. While the risk of infection or malignancy are common concerns, neurological complications, while rare, are also possible.