Type of information: Granting of a Market Authorisation in the EU
Product name: Erelzi® - etanercept biosimilar
Compound: etanercept biosimilar
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Dermatological diseases
Action mechanism: TNF alpha inhibitor/biosimilar. Etanercept is a competitive inhibitor of TNF, it binds to cell surface TNFR, preventing TNF
mediated cellular responses by rendering TNF biologically inactive. Etanercept may also modulate biologic responses controlled by additional downstream molecules (cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF.
Company: Sandoz (Switzerland)
Disease: rheumatoid arthritis, psoriasis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, paediatric plaque psoriasis
- • On June 27, 2017, Sandoz announced that the European Commission (EC) has approved Erelzi® (biosimilar etanercept) for use in Europe. Erelzi® is approved for use in all indications of the reference medicine, Enbrel® (rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis, and psoriatic arthritis, as well as juvenile idiopathic arthritis and pediatric plaque psoriasis). Erelzi® is available in a pre-filled syringe and an auto-injector pen, SensoReady®.
- The Phase III EGALITY study, which generated confirmatory efficacy, safety and immunogenicity data. The study included three treatment switches between the reference medicine and Erelzi. From baseline to Week 52, in both switched and continued treatment settings, EGALITY demonstrated no significant difference in mean Psoriasis Area and Severity Index (PASI) responses between Erelzi and the reference medicine. The primary endpoint of achieving equivalence in PASI 75 response rates at Week 12 was met[5,7]. The EGALITY study also confirmed the comparable safety profile of the two medicines over 52 weeks. Immunogenicity was low, as expected with etanercept treatment.• On April 21, 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Erelzi®, intended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis. Erelzi® will be available as a solution for injection (25 mg and 50 mg).
Erelzi is a biological medicinal product that is highly similar to the reference product Enbrel® (etanercept),which was authorised in the EU on 3 February 2000. Studies have shown that Erelzi® has comparable quality, safety and efficacy to Enbrel®.
- • On August 30, 2016, the FDA approved Erelzi® (etanercept-szzs) for all indications included in the reference product label Enbrel®, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA). Erelzi® is the second biosimilar from Sandoz approved in the US through the FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act. The FDA approval follows a unanimous vote (20-0) by the FDA's Arthritis Advisory Committee (AAC) in July to recommend use in all indications of the reference product. The approval is based on a comprehensive package of analytical, nonclinical, and clinical data confirming that Erelzi® is highly similar to the US-licensed reference product. Clinical studies included four comparative pharmacokinetic (PK) studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis. Extrapolation to all indications approved for use on the reference product label is on the basis that the Sandoz biosimilar etanercept and the reference product are essentially the same. An application for Sandoz biosimilar etanercept has been accepted by the European Medicines Agency (Q4 2015) and is currently undergoing review.
- • On December 8, 2015, Sandoz announced that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for a biosimilar to Pfizer's EU-licensed Enbrel® (etanercept) * - a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis. The regulatory submission to the EMA consists of a comprehensive data package that includes data from analytical, functional, pre-clinical and clinical studies. Sandoz believes that the two pivotal clinical studies; a pharmacokinetic (PK) study in healthy volunteers (HVs) and a confirmatory safety and efficacy study in patients with chronic plaque-type psoriasis (EGALITY), will provide clinical confirmation of similarity to the reference product established in extensive prior analytical comparability studies.
- • On October 2, 2015, Sandoz announced that the FDA has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's US-licensed Enbrel®* (etanercept) - a tumor necrosis factor alpha (TNF-alpha) inhibitor. Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis. This is the second BLA submission by Sandoz using the 351(k) biosimilar pathway.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2016-08-30
UE authorization: 2017-06-27
Favourable opinion UE: 2017-04-21
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: