The TGA has adopted several European biosimilar guidelines, including one on the non-clinical and clinical requirements for similar biological medicinal products containing monoclonal antibodies.

The guideline was released by the European Medicines Agency in 2012 and establishes the “general principles” of a development program to test the comparability of a biosimilar product to an innovator biologic.

The non-clinical section of the guidelines addresses the pharmaco-toxicological requirements and the clinical section the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as pharmacovigilance aspects.

“The overall aim of this guideline is to establish general principles that enable applicants for a development programme that establishes comparability of a biosimilar mAb with a reference mAb, while ensuring that the previously proven safety and efficacy of the drug is conserved” the guideline states.