Development of Etanercept biosimilars for the treatment of rheumatic disorders
In China, Shanghai CP Guojian Pharmaceutical (Sunshine Guojian Pharmaceutical since April 2016; a subsidiary of 3SBio) launched its first biosimilar of Etanercept as Yisaipu (Etveza) in 2006. The biosimilar, a tumor necrosis factor (TNF)- inhibitor is indicated for the treatment of rheumatic disorders like rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic rheumatoid arthritis, psoriatic arthritis and plaque psoriasis.
The biosimilar contains Etanercept, a fusion peptide, consisting of two molecules of the p75 TNF- receptor linked to the Fc portion of immunoglobulin G1. It reduces the signs and symptoms, inhibits the progression of structural damage, and improves physical function in patients with moderate to severe active rheumatoid arthritis, alone or in combination with methotrexate. It is available as a lyophilized powder and is administered by subcutaneous injection. In Colombia, the Etanercept biosimilar has been available since June 2011.
The phase III studies for the biosimilar of Etanercept has also been completed by Shanghai CP Guojian Pharmaceutical prior to March 2019. It appears that a licensing agreement between the originators and EMS has been made for the development of the Etanercept biosimilar in Brazil.
Yisaipu (Etveza) – The First Biosimilar of Etanercept
The first biosimilar of Etanercept, Yisaipu (Etveza) was launched in China by Shanghai CP Guojian Pharmaceutical, a subsidiary of 3SBio in 2006. It is the first biosimilar of Etanercept in the world. Yisaipu (Etveza) is indicated for the treatment of rheumatic disorders like rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis.
Used widely in about 3,00,000 patients, it is highly effective and safe. Yisaipu (Etveza) is the most cost effective biosimilar and has a market share of about 61%. Since then different biosimilars of E tanercept have been developed. Various pre-clinical trials have been carried out in China, Mexico and India to compare the efficacy and safety of Yisaipu (Etveza) to other biosimilars.
A phase III clinical trial conducted to assess the safety and efficacy of Etanercept for injection 25mg in patients with moderate to severe active rheumatoid arthritis concluded that Yisaipu (Etveza) is highly efficacious and has no significant safety concerns during its administration over a duration of 24 weeks in the Indian population. Research suggests that Etanercept is effective for disease activity control in patients with rheumatoid arthritis.
Need of biosimilars
The need for better quality disease-modifying antirheumatic drugs (DMARDs), similar in quality as the innovator and delivering the same result of treatment led to the development of biosimilars. Biosimilars are biologic medical products ‘highly similar’ to the reference product with ‘no clinically meaningful difference’ between the biosimilar and the reference drug. Biosimilars are safe and effective treatment options.
With the launch of Eteveza in Philippines, a biosimilar product of Innovator, patients with rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis that need Etanercept will get more access to treat the disease and reduce its long-term complications.
Biosimilars are said to not only relieve the financial burden of the government on reimbursement and to help doctors provide a better treatment with improved products but also to help cure patients with an affordable price.
Governments and patients are now counting on biosimilars to transform health care by reducing the cost of important biologics and to increase access to life-saving drugs. For that, these biosimilars will have to deliver the power of the reference drug at a price that the financially strapped countries can afford and gain the confidence of the marketplace.