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Baxalta’s Enbrel biosimilar measures up in late-stage study

Published on 13/01/16 at 04:38pm
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Having emerged from its mega-merger deal with Shire, Baxalta is back on its drug development day job – and has announced its Enbrel biosimilar met its primary endpoint in a comparison study with Pfizer and Amgen’s blockbuster.

The Phase III trial found CHS-0214, a proposed biosimilar of Enbrel (etanercept), met its primary endpoint in an ongoing study to evaluate its efficacy and safety compared to Enbrel. The drugs are being trialled in patients with moderate-to-severe rheumatoid arthritis that is inadequately controlled with methotrexate alone.

The primary efficacy endpoint was the proportion of subjects achieving ACR20 (a 20% improvement according to the American College of Rheumatology criteria) at Week 24. There were no clinically meaningful differences in the safety and immunogenicity profiles of the two products. The study will continue until patients have been treated for one year.

This rheumatoid arthritis study is the second of two Phase III trials intended to contribute to Baxalta’s global marketing applications for CHS-0214. Results for the first Phase III study in patients with chronic plaque psoriasis were released in November 2015, and found it also met its primary endpoints.

Enbrel earned Pfizer $2.4 billion in sales outside of the US and Canada, where the company markets the drug, in the first three quarter of 2015. It earned Amgen, which markets Enbrel in the US and Canada, $1.4 billion in the third quarter of 2015 – making it Amgen's best-selling drug.

But it is also a lucrative option for companies developing biosimilars – in its third quarter earnings report, Amgen had already begun to warn sales were “offset partially by the impact of competition.” Enbrel's patents for Europe expired in February last year, but its US patents will continue until 2028.

“Etanercept transformed the treatment for many with moderate to severe rheumatoid arthritis and other inflammatory conditions, significantly improving patients’ quality of life,” says Dagmar Rosa-Björkeson, executive vice president and president of biosimilars at Baxalta. “This important clinical milestone, adding to previously announced positive data in patients with chronic plaque psoriasis, brings us one step closer to expanding treatment options for patients.”

While Dr Barbara Finck, chief medical officer of Coherus, adds: “Rheumatoid arthritis that remains active despite methotrexate treatment has a significant impact on a patient’s health and quality of life. If approved, CHS-0214 has the potential to expand access and treatment options for patients with moderate-to-severe rheumatoid arthritis and other inflammatory diseases for which etanercept is indicated.”

Lilian Anekwe

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