Regulatory Framework and Challenges in Developing Biosimilar Monoclonal Antibodies and Related Biological Products

Monoclonal antibodies (mAbs)were initially used as laboratory reagents, later they were adopted as clinical diagnostic reagents, and eventually as therapeutic agents. The development of therapeutic mAbs commenced in the early 1980s and by 1986 the first mAbfor human use“Orthoclone OKT3”was approved by the US Food and Drug Administration (FDA). The next wave of antibody products weremostly anticancer agents which were approved in the US and Europe in the 1990s. The technological evolution from murine-based therapeutic mAbs to chimeric (part murine part human protein), humanized, and fully human antibodies has led to a reduction in immune-mediated clearance and hypersensitivity, improved the safety and feasibility of repeated administration making themtherapeutically viable.Since the commercialization of the first therapeutic mAb, these products have become a dominant component of the biopharmaceutical marketgenerating revenues of several billion dollars.The area of biosimilar antibody development is positioned for substantial growth with regulatory agencies like the European Medicines Agency (EMA) coming up with new guidelines on similar biological medicinal products followed by Health Canada, the US FDA and others, addressing biosimilar product development. With few of the blockbuster mAbs going off-patent in the next decade, companies with expertise in manufacturing biosimilar mAbs with the right kind of business and regulatory strategy are likely to have good value proposition.