AET BioTech, BioXpr partner to develop TNF inhibitor biosimilar

31st October 2012 (Last Updated October 31st, 2012 18:30)

AET BioTech and BioXpress Therapeutics have collaborated to develop a biosimilar version of the TNF inhibitor MAb Adalimumab.

AET BioTech and BioXpress Therapeutics have collaborated to develop a biosimilar version of the TNF inhibitor MAb Adalimumab.

As a part of the agreement, both the companies will be responsible for the development, registration and manufacture of the biosimilar that leverages BioXpress technology.

AET BioTech managing director Dr Harm Peters said the partnership will unite the technical and commercial strengths behind the Adalimumab biosimilar.

"The cooperation with BioXpress on our initial project is a key step in AET BioTech's mission to bring European quality biosimilar drugs to markets worldwide at fair prices," Dr Peters said.

AET BioTech is responsible for providing further investment in the biosimilar and also for future commercialisation of the product.

"The partnership will unite the technical and commercial strengths behind the Adalimumab biosimilar."

Non-clinical and clinical guidelines outlined in the European Medicines Agency's guideline on similar biological medicinal products containing monoclonal antibodies, will be followed in the development of Adalimumab biosimilar.

The product will also undergo ethical and comprehensive analytical and clinical comparison to ensure the similarity.

BioXpress chief executive officer and chair Dr Cori Gorman said the agreement is an important step in moving one of its biosimilar projects to the market.

"AET is well known for quality drug development, executing complex development and registration strategies and successful commercialisation worldwide, and this is particularly important when developing biosimilars," Gorman said.

"AET BioTech's commercial contacts, biosimilar development and registration experience and committed financial investment, and our MAb development expertise will help establish our companies as leaders in the biosimilar space."