Kelly Davio

February 18, 2019

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.

February 15, 2019

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.

February 14, 2019

Evidence to support treating inflammatory bowel disease (IBD), a category that includes Crohn disease and ulcerative colitis, with biosimilar infliximab continues to develop, and several new studies highlight the safety and efficacy of long-term treatment with CT-P13 (Inflectra, Remsima).

February 13, 2019

While the United States continues to await the launch of the first FDA-approved biosimilar etanercept (Erelzi), in other parts of the world biosimilars of the reference etanercept (Enbrel) are being widely used in clinical practice, and recent research reports on the role that biosimilar etanercept plays in the treatment of ankylosing spondylitis (AS).

February 13, 2019

Recent research attempted to assess consumer response to the disclosure of drugs' list prices in direct-to-consumer advertising.

February 12, 2019

Acute severe ulcerative colitis (ASUC) can occur in up to 25% of patients with UC. Salvage therapy with infliximab or cyclosporine is standard first-line therapy for patients who do not respond adequately to intravenous corticosteroids, but questions have arisen about the cost-effectiveness of this approach versus early colectomy. A recent study, conducted in a tertiary hospital network in Australia, sought to compare healthcare utilization and costs between patients with ASUC who had early colectomy and those who were treated with infliximab.

February 11, 2019

Drug maker Gedeon Richter’s RGB-02 is undergoing development as a proposed biosimilar to the reference pegfilgrastim, Neulasta, and researchers recently reported on the results of a phase 3 clinical study of the drug versus its reference in patients with breast cancer who were receiving chemotherapy.

February 08, 2019

GP2013, a biosimilar rituximab developed by Sandoz and licensed in the European Union under the brand names Rixathon and Riximyo, is used to treat both malignant and inflammatory diseases. A recently published paper, appearing in Arthritis Care and Research, says that researchers detected no safety risks when switching patients with rheumatoid arthritis from reference rituximab (Rituxan) to the biosimilar.

February 07, 2019

This week, Senator Patrick Leahy, D-Vermont, reintroduced The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act.

February 07, 2019

New research, published in BioDrugs, underscores the long-term efficacy and safety of treating rheumatoid arthritis (RA) with biosimilar rituximab, CT-P10.