Yisaipu, Biosimilar of Enbrel, Will be Available as Pre-filled Syringe in China

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by Patricia Inacio PhD |

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Yisaipu, ankylosing spondylitis

Yisaipu, a biosimilar of Enbrel (etanercept), has been approved in China as a pre-filled syringe to treat ankylosing spondylitis, among other conditions, announced the treatment’s developer, Sunshine Guojian Pharmaceutical, a subsidiary of 3SBio.

Because lack of adherence to treatment may be a cause for repeated disease onset, this new formulation is expected to boost the quality of life and treatment compliance for patients.

Like Enbrel, Yisaipu inhibits tumor necrosis factor (TNF), a cell-signalling molecule that plays an important role in helping the immune system fight diseases and infections. However, in people with ankylosing spondylitis and other inflammatory conditions, there is an overproduction of TNF, which leads to inflammation, pain, and swelling in the joints of the spine.

The new formulation of Yisaipu is a pre-filled syringe, the first of its kind to be sold in China, for patients to self-administer at home, and will be available in more dosages than what is currently sold.

Yisaipu is approved by China’s National Medical Products Administration for the treatment of adults, 18 or older, with active ankylosing spondylitis, moderate and severe active rheumatoid arthritis, and moderate to severe plaque psoriasis, an inflammatory skin condition.

“I am pleased to see that the application for the production of new drug for Yisaipu pre-filled aqueous injection solution has been successfully submitted and accepted,” Lou Jing, 3SBio chairman and CEO, said in a news release.

“3SBio will continue to focus on the biopharmaceutical field and is committed to exploring and developing more therapeutic biologics agents in different dosage forms, so as to meet different medical needs and provide patients with more choices,” he added.

Biosimilars are biological medications with a high degree of similarity to another already-approved biologic medicine in terms of quality, safety, and effectiveness. They are usually sold at significantly lower prices. Unlike chemical compounds, which are made through chemical reactions, biological medicines are grown in cells and may show some differences from similarly designed products.