Sandoz, the generic drug division of Swiss drug giant Novartis, is to start a phase III clinical trial for a biosimilar version of etanercept in patients suffering from psoriasis, according to the EU Clinical Trials Register.
The drug is a biosimilar version of Amgen’s blockbuster autoimmune disease treatment Enbrel (etanercept). Enbrel is a tumour necrosis factor (TNF) inhibitor that is approved to treat rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.
The Sandoz study will evaluate the efficacy, safety and immunogenicity of the company’s biosimilar etanercept (GP2015) versus Amgen’s Enbrel in patients with moderate to severe chronic plaque-type psoriasis. The choice to study psoriasis rather than rheumatoid arthritis points to the possibility that Sandoz may have received scientific advice from EMA regarding the potential for extrapolation from psoriasis data to other Enbrel indications.
The trial is a multicentre, double-blind, randomized, active controlled, parallel-group study. The main objective of the study is to demonstrate equivalent efficacy of GP2015 and Enbrel (etanercept) in patients with moderate to severe chronic plaque-type psoriasis with respect to Psoriasis Area and Severity Index (PASI) 75 response rate over an initial period of 12 weeks. The trial will include 372 patients, aged 18 years and above, with 282 being recruited from within the European Economic Area (EEA). Dr Alan Menter, Professor of Dermatology at Baylor University Medical Center in the US, is the lead investigator for the clinical trial. Results from the trial, which will be completed by November 2015, are expected to support regulatory submissions in both the US and EU.
Amgen’s sales of Enbrel in 2011 were US$7.4 billion making it a lucrative target for biosimilars manufacturers. Sandoz joins an ever-growing list of companies focusing on developing biosimilars of Amgen’s Enbrel, with Biocon/Mylan, Celltrion, Daiichi Sankyo/Coherus and Mycenax all having biosimilar versions of etanercept in clinical development. India-based generics’ manufacturer Cipla also launched its ‘similar biologic’ product Etacept in April 2013, the first ‘similar biologic’ of etanercept in India . Recently, a lobbying group of biopharmaceutical drug companies in India has raised concerns about the approval of Cipla’s first ‘similar biologic’ etanercept, used for the treatment of rheumatic disorders. The Association of Biotechlogy Led Enterprises (ABLE) have questioned whether Cipla complied with regulatory requirements in the Guidelines on Similar Biologics for selection of reference products, manufacturing process, quality-based considerations and clinical trial requirements. The main concern for ABLE appears to be the fact that Cipla sourced the drug from its Chinese partner.
Sandoz is also currently conducting phase II and III clinical trials for a biosimilar version of Roche’s leading monoclonal antibody Rituxan/MabThera (rituximab) , as well as phase III trials with biosimilar filgrastim (Amgen’s Neupogen) and biosimilar pegfilgrastim (Neulasta) .
Sandoz already markets biosimilar somatropin (Omnitrope), biosimilar epoetin alpha (Binocrit) and biosimilar filgrastim (Zarzio) in countries across Europe and elsewhere. Omnitrope, approved under the 505(b)(2) pathway of the Hatch-Waxman Act, is also marketed in the US.
Sandoz currently has more than two biosimilars on the market and the company has 8–10 molecules at various stages of development . With the start of its phase III study for its etanercept biosimilar, Sandoz now has seven phase III clinical trials covering five biosimilar molecules – more than any other company in the industry.
It should be noted that similar biologics approved in India might not have been authorized following as strict a regulatory process as is required for biosimilars in the EU. EMA regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
Etanercept and quality attributes changes
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Source: EU Clinical Trials Register, Sandoz, The Economic Times India
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