SANDOZ — Erelzi FDA Review (NDA/BLA 761042, 2018)
Novartis AG · 2018 · FDA Review (Drugs@FDA) · company profile →
Report summary
Sandoz Inc. received FDA approval on January 26, 2018, for Erelzi (etanercept-szzs), a biosimilar to Enbrel, for Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis (patients aged 2+), and Ankylosing Spondylitis. Indications for Psoriatic Arthritis and Plaque Psoriasis were later removed due to patent protection. Erelzi carries boxed warnings for serious infections (including TB and fungal) and malignancies (especially lymphoma in children/adolescents). The report details Erelzi's efficacy, including ACR response rates for RA, disease flare rates for JIA, and ASAS response rates for AS, often comparing it to placebo or methotrexate. It also covers comprehensive safety information, including adverse reactions, allergic reactions, autoimmunity, infections, injection site reactions, drug interactions, and use in specific populations (pediatric, geriatric, pregnancy/lactation). Storage, handling, and administration instructions for both prefilled syringe and Sensoready Pen formats are also provided.
Key findings — cited to the page
| Indication | Polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged 2 years or older | ERELZI (etanercept-szzs) · p.1 |
| Indication | Ankylosing Spondylitis (AS) | ERELZI (etanercept-szzs) · p.1 |
| Supplemental Biologics License Application (sBLA) date | July 27, 2017 | ERELZI (etanercept-szzs) · p.4 |
| Deletion of indications | Psoriatic Arthritis (PsA) and Plaque Psoriasis (PsO) | ERELZI (etanercept-szzs) · p.4 |
| Serious infections risk | Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens | ERELZI (etanercept-szzs) · p.8 |
| Malignancies risk | Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including etanercept products | ERELZI (etanercept-szzs) · p.8 |
| Indication | Rheumatoid Arthritis (RA) | ERELZI (etanercept-szzs) · p.8 |
| Indication | Polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged 2 years or older | ERELZI (etanercept-szzs) · p.8 |
| Indication | Ankylosing Spondylitis (AS) | ERELZI (etanercept-szzs) · p.8 |
| Adult RA dosage | 50 mg once weekly | ERELZI (etanercept-szzs) · p.8 |
| AS dosage | 50 mg once weekly | ERELZI (etanercept-szzs) · p.8 |
| Indication | Rheumatoid Arthritis (RA) | ERELZI (etanercept-szzs) · 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 →