biomolecules Review The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy Eva Rahman Kabir 1,* , Shannon Sherwin Moreino 1 and Mohammad Kawsar Sharif Siam 1,2 1 Department of Pharmacy, BRAC University, Dhaka 1212, Bangladesh 2 Department of Chemistry, University of Cambridge, Cambridge CB2 1EW, UK * Correspondence:
[email protected] Received: 12 June 2019; Accepted: 20 August 2019; Published: 24 August 2019 Abstract: The coming wave of patent expiries of first generation commercialized biotherapeutical drugs has seen the global market open its doors to close copies of these products. These near perfect substitutes, which are termed as “biosimilars”, do not need to undergo intense clinical trials for their approval. However, they are mandated to produce identical similarity from their reference biologics in terms of clinical safety and efficacy. As such, these biosimilar products promise to foster unprecedented access to a wide range of life-saving biologics. However, seeing this promise be fulfilled requires the development of biosimilars to be augmented with product trust, predictable regulatory frameworks, and sustainable policies. It is vital for healthcare and marketing professionals to understand the critical challenges surrounding biosimilar use and implement informed clinical and commercial decisions. A proper framework of pharmacovigilance, education, and scientific exchange for biologics and biosimilars would ensure a dramatic rise in healthcare access and market sustainability. This paper seeks to collate and review all relevant published intelligence of the health and business potential of biosimilars. In doing so, it provides a visualization of the essential steps that are required to be taken for global biosimilar acceptance.