Includes details on showing equivalence to reference products
The European Medicines Agency (EMA) has published final guidance on the development of biosimilar copies of monoclonal antibody (mAb) medicines.
The new document sets out the non-clinical and clinical requirements for biosimilar mAbs, including advice on carrying out pharmaco-toxicologic, pharmacokinetic, pharmacodynamic, efficacy and safety studies.
The guide is likely to be welcomed by companies seeking to develop biosimilars, as there has so far been a lack of regulatory guidance on showing equivalence of biosimilar mAbs to their reference products, hindering the development of the market.
Only a handful of biosimilar mAbs have reached market to date, notably ISU ABXIS' Clotinab (abciximab) and Dr Reddy's Reditux (rituximab) , although copies of many of the early-generation mAbs are already in clinical development.
A recent market research report from Frost & Sullivan said that the European biosimilar market would expand from a value of around $172m in 2010 to €4bn in 2017, representing a compound annual growth rate of 56.7 per cent. Driving the growth will be emerging biosimilar versions of mAb, insulin and interferon products.
"The focus of the guidance is on the careful demonstration of the comparability of a biosimilar monoclonal antibody with the monoclonal antibody in the original, authorised medicine," said the EMA.
"This is needed to make sure that the efficacy and safety demonstrated for the original medicine are conserved in the biosimilar medicine."
The agency has also finalised a second guidance document on the immunogenicity assessment of mAbs designed for in vivo clinical use. That document addresses issues related to the phenomenon in which patients can develop antibodies against mAb-based drugs, leading to reduced efficacy and potentially serious side effects.
It covers various strategies for systematically evaluating unwanted immunogenicity of mAbs, taking into account both quality and clinical aspects.
Both guidances are due to come into effect on December 1, 2012.