Biosimilars: The New Era of Drug Development?

  • Duc P Do K
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Introduction The biopharmaceutical industry has come a long way since the United States Food and Drug Administration (FDA) approval of the first biopharmaceutical (biologic) product insulin in 1982 [1]. In 2012, five of the top ten selling prescription drugs were biopharmaceuticals [2]. Biopharmaceutical products have provided novel treatment modalities for life-threatening and rare diseases. In recent years, pharmaceutical companies are ramping up on their development of biosimilars because many patents on biological products are expiring and this enables them to earn profits from the biopharmaceutical market [3]. Biosimilars are expected to offer competition to some of the most expensive drugs on the pharmaceutical market. Biosimilars are defined as a highly similar form of innovator’s biological products and are produced after the patent protections of such innovator biological products have expired [4-7]. Biosimilars are also known as follow-on biologicals, similar biologics, and similar biotherapeutic product or subsequent-entry biologics.




Duc P Do, K. O. S. (2013). Biosimilars: The New Era of Drug Development? Journal of Bioequivalence & Bioavailability, 05(06).

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