Biosimilar sponsors could skip India's efficacy trial requirement

India will allow sponsors of biosimilars to skip clinical efficacy trials if they meet several conditions for showing comparability to the reference biologic, according to recently released guidelines. The requirement to conduct confirmatory efficacy trials will be waived if the biosimilar shows structural and functional comparability in vitro; comparability in all preclinical studies; and comparability in a pharmacokinetic and pharmacodynamic study in healthy volunteers or patients. The sponsor also must develop a postmarketing risk management plan. The confirmatory study requirement cannot be waived if there is no reliable and validated PD marker. ...