Dallas, TX (PRWEB) March 22, 2014
Adalimumab is a TNF (tumor necrosis factor) inhibiting antiinflammatory drug, the first fully human monoclonal antibody drug approved by the FDA. It was discovered through collaboration between BASF Bioresearch Corporation and Cambridge Antibody Technology in 1993, then further manufactured at BASF Bioresearch Corporation and developed by BASF Knoll (BASF Pharma) and, ultimately, manufactured and marketed by Abbott Laboratories after the acquisition of BASF Pharma by Abbott. In 2000 Abbott Laboratories took over Knoll with USD 6.9 billion. At the end of 2002 adalimumab was approved to the market by FDA.
As of 2008 adalimumab (produced by Abbott with the trade name “Humira”) had been approved by FDA for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis. Adalimumab is the best seller in the world in recent years. It can satisfy many urgent clinical needs because of its wide range of indications. The global sales revenue of Humira in 2012 exceeded USD 9 billion, and it reached USD 10 billion in 2013. Humira was launched in China in August 2010. According to CRI’s market investigation, the sales revenue of adalimumab in Chinese sample hospitals grew 20 times from 2010 to 2013. More than 10 million people in China have adalimumab indications.
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Humira is expected to bring Abbott (now AbbVie) the total sales revenue of USD 100 billion before its patent expires in 2016. This has made Humira the primary target of pharmaceutical enterprises from the world. More than 20 enterprises worldwide are developing adalimumab generic drugs and many of them are Chinese enterprises.
Huahai Pharmaceutical announced in May 2013 that they signed a strategic alliance agreement with ONCOBIOLOGICS to jointly develop biological drugs. The agreement states that Huahai Pharmaceutical is bestowed with 100% marketing right of four monoclonal antibody biological drugs in China. If Huahai Pharmaceutical establishes joint ventures in the U.S. to develop the four monoclonal antibody biological drugs, it will have 51% of the marketing right in developed countries such as the U.S. and Europe.
Meanwhile the company will jointly establish a biopharmaceutical company with ONCOBIOLOGICS in China to develop monoclonal antibody biological drugs and conduct industrialization technique application research.
In December 2013 Huahai was informed by Oncobiologics that the MAb biosimilar Humira® jointly developed was approved to launch phase I clinical trial by EMA (the European Medicines Agency) and FDA.
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Duo to large market size, challenging R&D and high profit of the monoclonal antibody drug market, the collaboration between Huahai Pharmaceutical and Oncobiologics is praised by the industry as the “Second Transformation” supported by the international biopharmaceutical giant’s strong R&D strength. The approval for adalimumab to launch phase I clinical trial means a significant progress of the collaboration.
However, followup R&D of the monoclonal antibody product requires a large amount of time before the product appears on the market. It is estimated that Abbott will continue to occupy the global market of adalimumab in the next few years. However, the situation will change gradually after 2017.
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