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11 New Monoclonal Antibodies in Regulatory Review Spells Bright Future Ahead

Since the approval of Orthoclone OKT3 in 1986, the therapeutic monoclonal antibody industry has experienced three decades of continuous growth. Today there are over 40 market approved MAb products in the US and EU, having combined sales of over $75 billion in 2013. Our recent article entitled Monoclonal Antibody Targets and Indications, identifies three important industry trends based on an analysis of a bioTRAK® dataset. First, a number of the products currently in late stage development are focused on novel targets suggesting that the number of indications that will be successfully treated with MAb therapeutics is likely to grow. Second, several late stage development programs are focusing on developing improved antibody products against known molecular targets. These programs may yield “biobetters” for indications such as asthma, leukemia, non-small cell lung cancer, and multiple sclerosis. Third, there are 24 biosimilar development programs chasing the blockbuster revenue streams of six established innovator products.

As of July 1, 2015, there were 11 new MAb products under regulatory review for market approval either in the US and/or EU. In addition, two biosimilars have MAA applications under review; one a biosimilar to etanercept (Enbrel), and the other a biosimilar to infliximab (Remicade). Another 22 biosimilars are in Phase 3 development suggesting a competitive marketplace just over the horizon. An analysis of 62 MAb products in Phase 3 development finds autoimmune diseases and cancer to be the indication areas receiving the most development attention. However, approximately 1/4 of the MAbs in Phase 3 are for the treatment of indications outside these areas and include cardiovascular, neurological, and orthopedic diseases for which no approved MAb products currently exist.

MAbs as therapeutic agents continue to be viewed as attractive platforms for new drug development by industry. As the biopharmaceutical industry continues to grow, the number of molecular targets and therapeutic indications that can be treated with MAb products will undoubtedly increase. Many products that are currently in late stage development are focused on novel targets, confirming that the number of indications that will be treated successfully with MAb therapeutics in the future will be larger than today. In addition to antibodies in development against novel targets, several late stage development programs focus on developing improved antibody products against known molecular targets and these programs may yield “biobetters” for indications such as asthma, leukemia, non-small cell lung cancer, and multiple sclerosis. The result of both of these important trends –growth in indication areas treated by MAbs and growth of biosimilars – is likely to be an increase in the demand for manufacturing capacity to produce monoclonal antibodies.

 

Blog article by: Al Doig