Corporate Banner
Satellite Banner
Immunology
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

AET BioTech and BioXpress Therapeutics to Co-Develop Biosimilar Adalimumab

Published: Thursday, November 01, 2012
Last Updated: Thursday, November 01, 2012
Bookmark and Share
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 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.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,000+ scientific posters on ePosters
  • More than 4,500+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Gut Microbiomes Of Infants Have An Impact On Autoimmunity
Exposure to pathogens early in life is beneficial to the education and development of the human immune system.
Understanding Female HIV Transmission
Glowing virus maps points of entry through entire female reproductive tract for first time.
COPD Linked to Increased Bacterial Invasion
Persistent inflammation in COPD may result from a defect in the immune system that allows airway bacteria to invade deeper into the lung.
Finding Factors That Protect Against Flu
A clinical trial examining the body’s response to seasonal flu suggests new approaches for evaluating the effectiveness of seasonal flu vaccines.
Vaccinations Are More Effective When Administered In The Morning
Research from the University of Birmingham shows that influenza vaccinations have more protective responses when administered in the morning.
Secrets of a Deadly Virus Family Revealed
Scripps Research scientists uncover the glycoprotein structure of LCMV. The findings could guide development of treatments for Lassa fever.
Cytokine Triggers Immune Response at Expense of Blood Renewal
Research highlights promise of Anti-IL-1 drugs to treat chronic inflammatory disease.
Reduced Immune Response Causes Flu Deaths in Older Adults
Yale study suggests that immune response to flu causes death in older people, not the virus.
Exposure To Routine Viruses Makes Mice Better Test Subjects
Study shows that infections make mouse immune system act more like that in humans.
Immune Booster Tested in Advanced Merkel Cell Cancer
The immunotherapy drug produced durable responses in many patients.
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!