BioOutsource Introduces Biosimilarity Assays for Lucentis, Stelara, and Actemra

BioOutsource, a subsidiary of Sartorius Stedim Biotech that focuses on biologics contract testing and biosimilar characterization for the biopharmaceutical industry, announced on March 22, 2016 that it is releasing biosimilarity testing assays for three popular biologic products. The prepackaged, biosimilar characterization tests will specifically include binding and neutralization bioassays. "With the addition of these new assays, there are now over 40 assays for nine specific biosimilars from BioOutsource," a company respresentative told BioPharm International.

Although the company says it is focusing on these three biosimilars for now, according to a company press release, BioOutsource can also configure assays specifically to meet a biosimilar sponsor’s needs. “We’re delighted to bring new assays for testing Actemra, Stelara, and Lucentis biosimilars to market," said Daniel Galbraith, MD, chief scientific officer of Sartorius Stedim BioOutsource, in a press release. "This means we can now offer biopharma companies a comprehensive range of ready-to-use assays, which they can trust to determine precise comparability results and accelerate their biosimilar drug development.”

Genentech’s Lucentis (ranibizumab) is a product that blocks the production of vascular endothelial cell growth factor A (VEGF-A) in wet age-related macular degeneration; Genentech’s Actemra (tocilizumab) is a rheumatoid arthritis treatment; and Janssen’s Stelara (ustekinumab) treats plaque psoriasis and psoriatic arthritis.

Epirus is working on BOW090, a proposed biosimilar to Stelara. A Swiss company called BioXpress is developing a biosimilar to both Stelara and Actemra. Intas Pharmaceuticals launched Razumab in 2015 and is the first company globally to develop and launch a biosimilar version of Lucentis-but the biosimilar is only available in the European market. In the United States, Hospira partnered with Pfenex to develop and commercialize Pfenex's biosimilar candidate to Lucentis, PF582. Formycon AG and bioeq GmbH have a biosimilar to Lucentis, FYB201, in Phase III clinical trials. Lucentis comes off patent in the US in 2020 and in Europe in 2022, according to the Generics and Biosimilars Initiative (GaBI).

Sources, Sartorius Stedim Biotech, GaBI