Biosimilar

In June, the FDA approved burosumab for a second rare bone disease, expanded the indication for an interoperable insulin pump, cleared an integrated continuous glucose monitor, and approved a biosimilar and a new faster-acting insulin. 

The FDA approved a new drug application for a biosimilar to insulin glargine injection in vial and prefilled pens for children and adults with type 1 diabetes and adults with type 2 diabetes, according to an industry press release.

The FDA approved pegfilgrastim-apgf, a biosimilar intended to reduce infection incidence among certain patients with cancer.

By the end of 2019, the FDA had approved 26 biosimilar therapies, many of them with indications for rheumatologic and inflammatory diseases. However, there are just two biosimilars currently available in the U.S. market. This begs the question: what’s the holdup?

Bausch + Lomb announced an exclusive licensing agreement with Stada Arzneimittel and its development partner Xbrane Biopharma to develop and commercialize a biosimilar candidate to Lucentis in the U.S. and Canada.

Uptake of infliximab biosimilars has been slow throughout the University of Pennsylvania Health System compared with the nearby Philadelphia Veterans Affairs Medical Center, which has realized savings from their use, according to findings published in Arthritis & Rheumatology.

Despite their much-touted potential to drastically lower the cost of pricey biologics and improve care for patients across a spectrum of diseases, biosimilars have been slow to take root across the country, particularly in comparison with Europe.

The FDA on Thursday published a final rule outlining the application process for a new pathway for biological products, including biosimilar insulins, part of a larger effort to streamline the approval of more follow-on agents, spur competition and reduce costs, according to an agency press release.

The FDA and the Federal Trade Commission on Monday announced a partnership aimed at supporting the adoption of biosimilars and interchangeable products by deterring what they called “anti-competitive business practices,” such as false or misleading promotions, according to a joint statement.

Current cost savings alone from infliximab biosimilars are “insufficient to promote their widespread use” in the United States, and comparable savings to those achieved in some European countries may not be possible without systemic reform of the U.S. pharmaceutical market, according to findings published in Arthritis & Rheumatology.