June 19, 2013 – Sandoz is pleased that the European Medicines Agency (EMA) has issued a draft revised guideline on non-clinical and clinical issues in biosimilar product development.
Overall, the draft revised guideline demonstrates EMA’s continued worldwide leadership in biosimilar regulations by applying science in a risk-based manner that safeguards patient safety without compromising access to these important therapies.
Notably, the draft revision emphasizes the power of pharmacokinetics (PK) and pharmacodynamic (PD) studies in demonstrating biosimilarity over traditional efficacy trials involving large numbers of patients. Additionally, EMA acknowledges that strategies involving non-approved indications and non-inferiority trial designs may also be acceptable in certain circumstances. In this latest draft, the agency once again takes a risk-based approach to the design of non-clinical studies by suggesting that laboratory studies be conducted before determining whether any human trials are necessary. We also support the EMA in recognizing the importance of considering the totality of evidence – analytical, pre-clinical and clinical data- when determining the extent of data required for the extrapolation of safety across indications. We hope that it will provide more concrete language around the requirements for extrapolation in its final guideline.
We look forward to providing comprehensive feedback to the agency prior to the November 30th deadline for public comment. Sandoz continues to be committed to working with the EMA and other regulatory agencies around the world in increasing access to safe, effective, high-quality biosimilars.