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Global program seeks to confirm biosimilarity to support regulatory submissions in the US and EU.
Sandoz has initiated a major Phase III clinical trial with its biosimilar version of etanercept (Amgen's Enbrel), Sandoz announced in a press release. The global clinical trial will seek to confirm biosimilarity with regard to safety, efficacy, and immunogenicity of the Sandoz product versus Enbrel in patients with moderate to severe, chronic plaque-type psoriasis. The global clinical program was developed in consultation with regulatory authorities in the US and EU, and the results from this clinical trial are expected to support regulatory submissions in both regions.
Etanercept is a tumor necrosis factor alpha (TNFa) inhibitor produced using recombinant DNA technology and is approved in the US and EU for the treatment of rheumatoid arthritis, psoriasis, and other conditions. Sandoz has invested significant resources in state-of-the art analytical technologies to develop and validate a process for producing its biosimilar etanercept. The company is also making the necessary manufacturing investments to bring this complex biologic to market. Extensive pre-clinical and clinical data show that the Sandoz product is highly similar to Enbrel and justifies proceeding with late-stage clinical studies.
"The continued increase in spending on biological agents for treatment of immune-mediated diseases such as rheumatoid arthritis and psoriasis is a growing concern among physicians in many developed and developing countries," said Alan Menter, MD, professor and chairman of the Division of Dermatology at Baylor University Medical Center and immediate past president of International Psoriasis Council. "A high-quality and clinically-proven biosimilar version of etanercept could play an important role in generating much-needed savings for healthcare systems that can be used to fund novel therapies or treat more patients."