Sandoz begins Phase III clinical trial for biosimilar adalimumab

December 19, 2013 9:33 AM

Sandoz, announced it has initiated a Phase III clinical trial with its biosimilar version of adalimumab.

Adalimumab is the monoclonal antibody Humira and used for treatment of several autoimmune conditions including rheumatoid arthritis, psoriasis, and Crohn’s disease. This is Sandoz’s eighth Phase III trial initiation across six compounds.

  • Sandoz advances leading biosimilars pipeline by strengthening immunology portfolio
  • Global program marks Sandoz’ sixth biosimilar molecule to enter Phase III testing
  • Trial will support registration in the U.S. and European Union

The aim of the study is to demonstrate equivalent efficacy, similarity, and immunogenicity of the Sandoz product versus Humira in patients with moderate to severe plaque-type psoriasis. Sandoz is working closely with physicians and patients on this global trial, which spans 12 countries across Europe, the United States and Asia including Japan.

Psoriasis affects approximately 3% of the world’s population. There is significant unmet need in psoriasis with between nine and 30 percent of patients with severe psoriasis receiving no treatment at all. “Because psoriasis is a chronic condition that often requires lifelong management, treatment can become a significant financial strain for many patients and healthcare systems,” said Professor Dr. Peter van de Kerkhof, Chairman of the Department of Dermatology at the Radboud University Nijmegen Medical Centre in The Netherlands and President of the International Psoriasis Council (IPC) Board of Directors. “A high-quality and clinically proven biosimilar version of adalimumab could play a meaningful role in alleviating cost burdens related to this disease.”

“This latest advancement in our pipeline represents our unwavering commitment to expanding patient access to biologics – particularly in disease areas where there is a significant need for more treatment choices,” said Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz. “We look forward to bringing a high-quality and affordable biosimilar version of adalimumab to individuals around the world living with psoriasis and other debilitating autoimmune diseases such as rheumatoid arthritis.”

“Adalimumab will be a key building block in our growing Immunology portfolio, which includes other biosimilar candidates currently in Phase III trials such as etanercept (Amgen’s Enbrel) and rituximab (Roche’s Rituxan/MabThera),” said Ameet Mallik, Sandoz’ Head of Biopharmaceuticals and Oncology Injectables. “This key development milestone further strengthens our global leadership in biosimilars and builds on our industry-leading pipeline.”

Sandoz is the pioneer in biosimilars and the global market leader with over 50 percent market segment share of all biosimilars approved in the highly regulated markets of U.S., Canada, Europe, Japan and Australia. All three Sandoz biosimilars occupy the #1 biosimilar position (volume market share) in their respective categories. Sandoz biosimilars are sold in over 50 countries and have generated over 100 million patient exposure days in experience.


Source: Sandoz press release

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