Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel((R))).
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Hofmann HP, Kronthaler U, Fritsch C, Grau R, Muller SO, Mayer R, Seidl A, Da Silva A
Characterization and non-clinical assessment of the proposed etanercept biosimilar GP2015 with originator etanercept (Enbrel((R))).
Expert Opin Biol Ther. 2016 Oct;16(10):1185-95. doi: 10.1080/14712598.2016.1217329. Epub 2016 Aug 16.
- PubMed ID
- 27463856 [ View in PubMed]
- Abstract
BACKGROUND AND OBJECTIVE: Biosimilars are approved biologics that are comparable to an originator product with respect to quality, safety and efficacy. Herein, the authors describe the functional and non-clinical studies designed to determine the biosimilarity of GP2015 and originator etanercept (Enbrel(R)). METHODS: The development of an Enbrel biosimilar (GP2015) involved extensive characterization of the originator. A step-wise target-directed and iterative technical development program involving state-of-the-art functional characterization studies and non-clinical evaluations (pharmacokinetics, pharmacodynamics and safety/toxicology) was applied with the aim of confirming that GP2015 is comparable to originator (Enbrel) at the non-clinical level. RESULTS: In in vitro tests, GP2015 and Enbrel had comparable binding affinities to TNF-alpha, C1q complement and a complete panel of Fc-Receptors. Comprehensive functional characterization testing confirmed the comparability of GP2015 with Enbrel in terms of its ability to bind to and neutralize TNF-alpha, which reflects the primary mechanism of action of etanercept. Non-clinical data confirmed that the proposed biosimilar to Enbrel, GP2015, is comparable with regards to its pharmacokinetic properties and pharmacodynamic activity, and efficacy as well as safety/toxicity. CONCLUSION: The proposed Enbrel biosimilar, GP2015, was shown to be comparable to its originator product in studies designed to confirm biosimilarity.
DrugBank Data that Cites this Article
- Drugs
- Drug Targets
Drug Target Kind Organism Pharmacological Action Actions Etanercept Complement component 1q (C1q) (Protein Group) Protein group Humans UnknownLigandDetails Etanercept High affinity immunoglobulin gamma Fc receptor I Protein Humans UnknownLigandDetails Etanercept Low affinity immunoglobulin gamma Fc region receptor II-a Protein Humans UnknownLigandDetails Etanercept Low affinity immunoglobulin gamma Fc region receptor II-b Protein Humans UnknownLigandDetails Etanercept Low affinity immunoglobulin gamma Fc region receptor III-A Protein Humans UnknownLigandDetails