Sandoz Launches Phase III Clinical Trial for Biosimilar Etanercept - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Sandoz Launches Phase III Clinical Trial for Biosimilar Etanercept


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."

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
26%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns

Click here