Abstract
The biologic drugs are naturally more complex than drugs of chemical origin. Their efficacy, quality and safety are influenced by their primary, secondary and tertiary structure, post-translational changes, biologic, immuno-chemical and physico-chemical characteristics.
Due to this complexity, it is impossible to develop an exact copy of original drug with expired patent. Therefore, a biosimilarity concept was developed, with the comparability exercise and extrapolation of indications, using previously known approaches applied i.a. after the change of manufacturing process of the original biologic products.
There are two levels of regulation of biosimilars within the EU: authorisation process is performed by European Medicines Agency, while pricing, reimbursement, prescribing and interchangeability are dealt on national level. Guidelines setting up the criteria for possibilities of extrapolation and critical qualitative criteria for the comparability exercise are important parts of the authorisation regulation and processes.
After the initial reservations, the concept of extrapolations is now being accepted by the professional healthcare community more widely. In any case, pharmacists should play a key role in education, counselling and medicines optimisation processes in area of biologics.