Today, Sandoz announced that it has initiated a major Phase III clinical trial evaluating the company’s biosimilar version of Amgen’s Enbrel (etanercept) for patients with moderate to severe chronic plaque-type psoriasis.
The company’s clinical trial will seek to confirm biosimilarity with regard to safety, efficacy, and immunogenicity of the product versus Enbrel for psoriasis patients instead of the major rheumatoid arthritis indication. This will likely be a simpler target for Sandoz to gain experience while testing the treatment. In development with US and EU regulatory authorities, results from the clinical trial are expected to support regulatory submissions in both the US and EU.
“Sandoz has a strong track record in developing and commercializing biosimilars around the world,” Ameet Mallik, Head of Biopharmaceuticals and Oncology Injectables at Sandoz, stated. “We will leverage this experience and our industry-leading capabilities to bring biosimilar version of etanercept to patients and physicians around the world.”
Sandoz faces hurdles in the US, since in 2011 Amgen announced that the company had landed a new patent on Enbrel that would keep biosimilar competition away for up to 17 years. Amgen’s central patent on Enbrel has an expiration of 2012. According to Sandoz, significant resources have been invested in state-of-the-art analytical technologies to develop and validate a process for producing its biosimilar etanercept. The company has extensive pre-clinical and clinical data that show its product is highly similar to Enbrel and justifies proceeding with late-stage clinical studies.
“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,” Alan Menter, MD, Professor and Chairman of the Division of Dermatology at Baylor University Medical Center in Dallas and past President of International Psoriasis Council, said.
As the global market leader in biosimilars, Sandoz now has seven Phase III clinical trials across five biosimilar molecules and all three of the company’s products hold the number one biosimilar position in their respective categories.
Last Updated: 6/24/13; 3:35PM EST