Discussion on the Prospect of Biosimilar Monoclonal Antibodies Drugs
In the past few years, monoclonal antibody drugs have dominated the world's largest bio-pharmaceutical drug sales, and in the coming years, monoclonal antibody drugs will continue to be the main force.
The rapid development of monoclonal antibody drugs as well as the approaching of patent expiration for many "blockbusters", such as Johnson & Johnson's anti-tumor necrosis factor (TNF)-α monoclonal antibody—Remicade which will be expired in the United States and Europe in 2018 and 2014, respectively. Considering the huge profit margins and potential market, the monoclonal antibody-based therapeutics is the hot territory many pharmaceutical companies chase.
As we all know, the structure of monoclonal antibody drugs are much complex than small molecule drugs, which decides the hard approval process and rugged experience. Three of the difficulties are post-translational modifications, three-dimensional structure and protein aggregation, which may lead to changes in immunogenicity and antibody targeting, thereby causing a decline in therapeutic activity. This is the common problem that limits the development and production of biosimilars.
The following shows some issues and events affecting the industry and market, including:
• Demand for biosimilars - rising production needs
• Research and development (R&D) for those protein-based medicines
• FDA biosimilar guidelines and state regulation of biosimilar substitution
• Legal challenges for those substitute drugs
• Biobetters as a threat to biosimilars
• EMA regulations, and those of other regions
• Collaboration in follow-on mAb development
• Big pharma and the biosimilar mAbs market.
There are reasons to believe that in near future, monoclonal antibody-based generic drug will overcome difficulties and occupy an advantage position in biosimilars market.