SGS and DiscoverX to supply bioassays for biosimilar development

03-Apr-2016 - Last updated on 04-Apr-2016 at 10:13 GMT

Image: iStock/luchschen

SGS has teamed with DiscoverX to offer bioassays for assessing the potency of prospective biosimilars of Roche’s Avastin and BMS’s Erbitux.

Biopharma verification and testing company SGS is working with Californian cell-based assays supplier DiscoverX Corporation to offer drug developers ready-to-assay cryopreserved cells in a qualified kit for the evaluation of potential biosimilar products.

Initially, data is being presented on the mechanisms of action for Bristol-Myers Squibb’s epidermal growth factor receptor (EGFR) inhibitor Erbitux (cetuximab), Roche’s angiogenesis inhibitor Avastin (bevacizumab), and ADCC (antibody-dependent cell-mediated cytotoxicity) for cetuximab, as well as evaluating AstraZeneca’s Bydureon (exenatide), a GLP-1 agonist synthetic version of the hormone exendin-4 found in the saliva of the Gila monster and

“SGS has worked together with DiscoverX as this company has developed innovative kits to support drug development programmes, and particularly bioassays for the assessment of innovator/biosimilar potency,” SGS’s global director for biopharma services Dr. Fiona Greer told this publication.

“SGS has now performed the qualification of these bioassays with an evaluation of kit suitability for the purpose of biocomparability. The validation of these bioassays will be performed with clients’ compounds to establish criteria to be used in biocomparability study.”

Erbitux lost its exclusivity in the US earlier this year, while Avastin is set to come off patent in 2019, and are among the second wave of biological products which have a number of biosimilar versions in development.

According to Greer, the ready-to-use bioassays will help developers overcome challenges in method development procedures and expedite quality control (QC), lot release, and stability testing of biosimilars.

Last month, Sartorius Stedim Biotech (SSB) – through its subsidiary BioOutsource - announced it was launching new bioassays for testing Actemra, Stelara, and Lucentis biosimilars, complementing its pre-developed assay portfolio.