Summary of the diverse situation of similar biotherapeutic products in the selected countries (August 2010).

The WHO guidelines on evaluating similar biotherapeutic products (SBPs) were adopted by the Expert Committee on Biological Standardization in 2009. The fundamental messages of the guidelines are that a) generic approach is not suitable for licensing SBPs, b) only products that have been subjected to a comparability exercise and show similarity to the reference biotherapeutic product (RBP) in terms of their quality, safety and efficacy are defined as SBPs, and c) the products that are not shown to be similar to the originator products as indicated in the guidelines should neither be described as "similar" nor called SBPs. In view of these, the products which have not been subjected to a head to head comparison with the RBP should be referred to as another term, e.g. 'non-innovator' therapeutic products. In order to review the current situation in each country, a survey was planned in line with the implementation workshop of the guidelines in August 2010. The results show that the diversity of regulatory framework for licensing SBPs and the ambiguous use of the terms, 'similar' or 'generic', present considerable challenges for the future use of SBPs.