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:
http://matriksbiotek.com/files/manuals/S-AIR.pdf
For product insert:
http://matriksbiotek.com/files/manuals/S-AIR.pdf
REFERENCES:
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.
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