A biosimilar is highly similar to, but not exactly the same as the existing, FDA-approved biologic, called the “reference” drug. People are familiar with generic versions of brand-name drugs, but biosimilars are not generic drugs. Generic versions of brand-name drugs are exact copies of chemically synthesized medicines. Biosimilars are not-quite-perfect copies of biologics drugs derived from living cells that are impossible to replicate exactly.
Development of biosimilar proteins will present drug developers with a variety of challenges, both in manufacturing and in the clinic. Immunogenicity will prove to be one of the biggest challenges. Proper design and validation of an assay to detect anti-drug antibodies and accurate interpretation of sample analysis results will prove integral to developing a biosimilar protein.
Taking the above and below-mentioned into account Matriks Biotek® produced SHIKARI® S-AIR v2 for quantitative ELISA kit as the first ELISA kit for the biosimilar of Infliximab, CT-P13 (Remsima®; Inflektra®) with confirmation reagent.
Comparisons for measuring especially ADA’s and trough levels are made by the tests developed for reference drug, not for biosimilar which may (or may not) differ on the test results. On the contrary we do not know the results when comparisons done by the ELISA kit developed for the biosimilar drug, it can present low immunogenicity as well. Regulatory organizations (FDA, EMEA) requires PK/ADA tests to be done by biosimilar drug in comparison to reference drug.
Matriks Biotek® offers to develop custom ELISA kits for your biosimilars or biologics on contract manufacturing basis depending on the molecule provided and with the agreements done by other CRO and GLP companies can also provide Phase 1 studies in collaboration.
Matriks Biotek® is the first company to commercialize SHIKARI® ELISA kits for biological drug testing to measure trough levels and anti-drug antibodies (immunogenicity) since 2008.
For product insert:
For product insert:
1. Farkas K., et al., Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis. Journal of Crohn's and Colitis Advance Access published April 21, 2016
2. Malíckova K, et al., Serum trough infliximab levels: A comparison of three different immunoassays for the monitoring of CT-P13 (infliximab) treatment in patients with inflammatory bowel disease, Biologicals 2015.
3. Farkas K. et al, Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn’s disease and ulcerative colitis experiences from a single center. Expert Opin. Biol. Ther. 15:(9) 2015.