Abstract
Compared to well-established generic medicines that are routinely developed using the bioequivalence approach and identical drug substances, biosimilars are developed using a step-wise comparability exercise aimed at demonstrating similar but not identical quality, non-clinical and clinical attributes. Biosimilar development is not intended to demonstrate the clinical benefits of the product as millions years of exposure data are currently available for the many originator monoclonal antibodies but rather to demonstrate a high degree of similarity against the reference using analytical and non-analytical state-of-the-art quality, non-clinical and clinical tools. It is therefore assumed that biosimilar development will be strongly based on the well-studied safety profiles of the originator product. The scope and size of the biosimilar safety database will be propelled by a risk-driven evaluation of biosimilarity and immunogenicity-attributed risks. The first driver for biosimilars is the expiry of patents for several originator biologic products with a significant revenue stream. Secondly, many stakeholders, especially payers and patients, need earlier and expanded access to affordable biologics, and biosimilars could provide substantial budget savings. With a more mature and defined regulatory framework surrounding biosimilars, a number of biosimilar players have emerged in the last few years including contract research organizations (Parexel, Quintiles), generic (Sandoz, Teva, Hospira), innovative companies (Merck Ventures, Merck & Serono, GSK, Pfizer, etc.) and even some companies with no prior pharmaceutical expertise who are moving into the biosimilar business (Samsung, LG Life Sciences, Fuji Pharma). The objective of this article is to highlight some important commercial, regulatory and developmental trends relating to biosimilars, across developed and emerging markets.
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