AET BioTech and BioXpress Therapeutics to Co-Develop Biosimilar Adalimumab
News Nov 01, 2012
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 commercialisation 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, PhD, MBA, 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.
Mechanism Controlling Multiple Sclerosis Risk IdentifiedNews
Researchers at Karolinska Institutet have now discovered a new mechanism of a major risk gene for multiple sclerosis (MS) that triggers disease through so-called epigenetic regulation. They also found a protective genetic variant that reduces the risk for MS through the same mechanism.
Herpesvirus and Alzheimer's Link: High abundance of Herpes genes in postmortem Alzheimer's brain tissueNews
Data from three different brain banks to suggest that human herpesviruses are more abundant in the brains of Alzheimer's patients and may play a role in regulatory genetic networks that are believed to lead to the disease.READ MORE
Sartorius Stedim Biotech and Siemens Sign Automation AgreementNews
Siemens becomes a preferred supplier for automation solutions. Product portfolio of Sartorius Stedim Biotech to feature a globally standardized automation platform in the future.READ MORE