BIOBETTERS: THE BETTER BIOLOGICS AND THEIR REGULATORY OVERVIEW

Abstract

The continuous innovation of the biopharmaceutical industry has led to development of a new category of biopharmaceuticals i.e. Biobetters or Biosuperiors. Biobetters may have better efficacy, a longer half-life, lower dosing frequency, a reduced risk of immunogenicity, reduced toxicity and side effects along with lower early-stage research risk and development costs. Biobetters rather than biosimilars may capture significant share of market and are the next wave for companies to ride on. Although it sounds intuitive, biobetters will have to face various ordeals like identification of the apparent unmet need, quantification of the potential market opportunity, expensive investment in clinical trials, challenging regulatory approval, pressures of price erosion and patent litigations. Thus, development of biobetters truly requires the right balance between providing life-changing medical management for patients and maintaining an innovative pipeline for continued business success. This review will focus on technical and regulatory prospects of biobetters.