Biowaivers and Biosimilars Reinforcing Intent and Content of Researchers and Regulators

Abstract

Over the past two decades, the healthcare costs have swelled exponentially particularly in the developed world. In the USA alone, the annual healthcare budget is estimated at around $ 3 trillion. Addressing this growing burden continues to be their major policy priority. One of the ostensible ways to make healthcare cheaper is the manufacture and use of generic drugs. Consequently today, majority of pharma industrial houses are eyeing on the drug molecules going off-patent and developing their generics. Customarily, these generic dosage forms have to establish their efficacy and cost-efficacy vis-a-vis their branded counterparts. A generic product, however, can solely be considered therapeutically equivalent to the reference listed drug (RLD), if it demonstrates bioequivalence with the RLD. The exceptions can only be a parenteral, ophthalmic or otic solution, inhalations or products intended for topical use. Needless to mention, such bioequivalence trials are known to be quite arduous, expensive and time-consuming. Lately, with the introduction of a vast majority of drug molecules exhibiting highly variable absorption, involvement of hundreds of volunteers is required. Eventually this tends to escalate the overall formulation development expenditure phenomenally, thus calling for biowaivers.Biowaivers can be obtained through twin pathways; first via a valid