SANDOZ — Erelzi FDA Summary Review (NDA/BLA 761042, 2016)
Novartis AG · 2016 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
Sandoz's Biologics License Application for GP2015 (Erelzi), a biosimilar to Enbrel, was approved for all Enbrel's indications. This approval was based on comprehensive analytical, pharmacokinetic, and clinical data, including a comparative study in plaque psoriasis, which demonstrated high similarity and no clinically meaningful differences between GP2015 and US-licensed Enbrel. Biosimilarity was successfully extrapolated to other indications like rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, and psoriatic arthritis due to similar pharmacokinetic and immunogenicity profiles. Postmarketing requirements include developing a dose-adjustable presentation for pediatric patients under 63 kg and fulfilling various analytical and manufacturing commitments.
Key findings — cited to the page
| BLA submission type | 351(k) biologic license application | GP2015 · p.3 |
| Number of PK studies | 4 | GP2015 · p.3 |
| Study 102 design | single center, randomized, double-blind, two-way crossover study with two treatment periods comparing a single-dose 50 mg SC injection of GP2015 and US-licensed Enbrel | GP2015 · p.9 |
| Study 102 enrollment | 54 subjects | GP2015 · p.9 |
| PK similarity (90% CIs for ratios of geometric mean of AUC0-inf, AUC0-τlast, and Cmax) | within 80% to 125% | GP2015 · p.9 |
| PK similarity (90% CIs for ratios of geometric mean of AUC0-inf, AUC0-tlast, and Cmax) | within 80% to 125% | GP2015 · p.9 |
| PK comparability (90% CIs for geometric mean ratios of AUC0-t, AUC0-inf, and Cmax) | within 80-125% | GP2015 · p.9 |
| Study 302 enrollment | 531 subjects | GP2015 · p.10 |
| Study 302 randomization to GP2015 arm | 264 subjects | GP2015 · p.10 |
| Study 302 randomization to EU-approved Enbrel arm | 267 subjects | GP2015 · p.10 |
| PASI 75 at Week 12 (GP2015) | 70.5 % | GP2015 (Study 302) · Europe, South Africa · p.11 |
| Application Number | 761042Orig1s000 | GP2015 · p.1 |
Source: Novartis AG ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →