Sandoz launches Phase III clinical trial for biosimilar etanercept

Sandoz, the global leader in biosimilars, announced it has initiated a major Phase III clinical trial with its biosimilar version of etanercept (Amgen’s Enbrel®). 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 U.S. and EU, and the results from this clinical trial are expected to support regulatory submissions in both the U.S. and EU.

“Sandoz has a strong track record in developing and commercializing biosimilars around the world,” said Ameet Mallik, Head of Biopharmaceuticals and Oncology Injectables at Sandoz. “We will leverage this experience and our industry-leading capabilities to bring a biosimilar version of etanercept to patients and physicians around the world.”

Etanercept is a tumor necrosis factor alpha (TNFa) inhibitor produced using recombinant DNA technology, and is approved in the U.S. 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, M.D., Professor and Chairman of the Division of Dermatology at Baylor University Medical Center, Dallas, United States 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.”

“Sandoz remains steadfast in its commitment to significantly increase worldwide access to essential, high-quality and life-enhancing biopharmaceuticals,” said Mark McCamish, M.D., Ph.D., Head of Global Biopharmaceutical Development at Sandoz. “The initiation of this clinical trial stands as an important testament to our deep commitment.”

Sandoz is the pioneer in biosimilars and the global market leader with over 50% share of all biosimilars approved in the highly regulated markets of U.S., Canada, Europe, Japan and Australia. All three Sandoz products occupy the #1 biosimilar position in their respective categories. Sandoz biosimilars are sold in over 50 countries and have generated over 100 million patient exposure days in experience. Sandoz also has an unrivalled pipeline with several molecules in various stages of development. With the start of the etanercept Phase III study, Sandoz now has seven Phase III clinical trials across five biosimilar molecules – more than any other company in the industry.