Biosimilars: A futuristic fast-to-market advice to developers
Sarfaraz K. Niazi
Abstract
INTRODUCTION: Biosimilars are expected to improve the accessibility of biological drugs, a goal that has not been reached because of the high cost of development. This is about to change based on the history of biosimilars' safety, the regulatory agencies' flexibility in reducing the testing requirements, and the scientific advances in analytical methods to enable better assessment of biosimilarity. AREAS COVERED: Regulatory development plan supporting justification of fewer studies, including a selection criterion for the critical quality attributes, determination of the relevance of testing, and designing intelligent clinical testing protocols to reduce the time to market. EXPERT OPINION: The safety and efficacy of biosimilars can be established only based on analytical assessment and clinical pharmacology comparisons. Waivers of animal toxicology and pharmacodynamic studies and clinical efficacy and safety studies will not be required as these studies add little value in supporting the claim of biosimilarity.