Sandoz initiates phase 3 psoriasis trials

Novartis’ generics business, Sandoz, has initiated a major phase 3 clinical trial with its biosimilar version of etanercept (Amgen’s Enbrel) for patients with moderate to severe chronic plaque-type psoriasis.

Etanercept is a tumor necrosis factor alpha (TNFα) inhibitor produced using recombinant DNA technology, and is already approved in the US and EU for the treatment of rheumatoid arthritis, psoriasis, and other conditions.

“Sandoz has a strong track record in developing and commercializing biosimilars around the world. We will leverage this experience and our industry-leading capabilities to bring a biosimilar version of etanercept to patients and physicians around the world.”

Ameet Mallik, Head of Biopharmaceuticals and Oncology Injectables at Sandoz.

The global clinical trial will seek to confirm biosimilarity with regard to safety, efficacy and immunogenicity of the Sandoz product versus Enbrel. Developed in consultation with regulatory authorities in both the US and the EU, the results are expected to support both regulatory submissions.

With the start of this clinical trial, Sandoz now has seven phase 3 clinical trials across five biosimilar molecules, which is more than any other company in the industry.


Related news:

Novartis tests copy of Amgen’s Enbrel in late-stage trial (Reuters)

Reference links:

Sandoz press release

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