AET BioTech, the separate biosimilars business within the generic drug developer AET (Alfred E Tiefenbacher) Group and BioXpress Therapeutics SA, a Swiss-based biotechnology company developing monoclonal antibody (MAb) biosimilars have entered into an agreement for the co-development of a biosimilar version of the TNF inhibitor MAb Adalimumab. AET BioTech and BioXpress will be jointly responsible for the development, registration, and manufacture of the biosimilar, which is based on BioXpress technology. The development strategy devised and implemented by the partners incorporates regulatory requirements for marketing in countries worldwide. Beside active involvement in the development of the MAb, AET BioTech will in particular be responsible for providing further investment in the biosimilar based on committed long term financing. AET BioTech is also responsible for any future commercialization of the product. Adalimumab as currently marketed by Abbott had 2011 global sales exceeding $7.9 billion USD.
“The BioXpress team has an impressive track record in the development of the initial originator MAbs, and access to state of the art MAb know-how and technology, and the partnership will unite our technical and commercial strengths behind the Adalimumab biosimilar,” said Dr Harm Peters, Managing Director of AET BioTech. “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.”
“The AET BioTech BioXpress agreement is an important step in moving one of our biosimilar projects to the market. AET is well known for quality drug development, executing complex development and registration strategies and successful commercialization worldwide, and this is particularly important when developing biosimilars,” said Cori Gorman, Chief Executive Officer and Chair of BioXpress Therapeutics SA. “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.”
The Adalimumab biosimilar will be developed under strict non-clinical and clinical guidelines as outlined in the European Medicines Agency’s “Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies,” the current standard for biosimilar registration incorporated into and referenced by biosimilar legislation in countries worldwide, and will also include non-EU requirements into planning at an early stage. It will undergo ethical and comprehensive analytical and clinical comparison to the innovator product to establish its similarity accordingly.
Biosimilars or follow-on biologics are terms used to describe therapeutics that are highly similar to innovator biopharmaceutical products. Reference and comparison to the innovator product is an integral component of the approval process.
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