Biological Medicinal Products are characterized as products that their active ingredient or ingredients are produced from a biological source or products that are homogenized from a biological source. Biosimilar Medicinal Products, however, are human medicinal products that demonstrate high level of similarity to a licensed biological reference medicinal product and their licencing procedures are executed by the Regulation on Licencing of Human Medicinal Products (the “Regulation”) just like chemical medicinal products. Nevertheless, detailed provisions on biosimilar products does not exist in the Regulation, the procedures and principles regarding licencing of biosimilar products is regulated under Guideline on Biosimilar Medicinal Products (the “Guideline”) which is prepared by Turkish Medicines and Medical Devices Agency (the “Agency”) in reference to the Regulation. In this context, the Guideline is updated by the Agency and the amendments have been published in the official website of the Agency on 14 September 2021.
The previous version of the Guideline was more of a resource which complies the referable legislation regarding the processes about biosimilar medicinal products. With the comprehensive amendments that have been made, the Guideline provides more detailed regulations on licencing processes of biosimilar products. Accordingly, articles regarding purpose, scope and definitions of the Guideline have been detailed, additionally more comprehensive articles regarding the subjects on fundamental principles, production processes, clinical studies, non-clinical studies and pharmacovigilance have been prepared.
In this context, firstly the purpose and the scope of the Guideline have been written more detailed and it is emphasized that, other up to date national/ international guidelines specific to this product and this product segment are supplementary to the Guideline. The Guideline that includes only biosimilar drug and biological drug definitions before, currently become inclusive to definitions such as pharmacopeia, reference medicinal product and comparator medicinal products.
Fundamental principles regarding licencing biosimilar products have been regulated in more detail, within this framework, advisory principle rules on how to select the reference medicinal product and how to prove biosimilarity have been identified.
The Guideline has also brought new regulations regarding the quality standards that has to be provided in production of the biosimilar products, included detailed information on comparability and characterization studies to provide a Quality Target Product Profile (QTPP) which can be compared with reference medicinal product and obtain valid data in biosimilar medicinal product development process.
Section on Clinic and non-clinic studies which were only referred to relevant guidelines in previous regulation, have been re-regulated in detail and technical means that will be taken into consideration have been included. Within this context, principle rules regarding non-clinical in-vivo and in-vitro studies which will be conducted to support biosimilarity have been presented. In other respects, regulations have been made on clinical comparison studies, it is regulated that as a principal, studies will be conducted incrementally beginning with pharmacokinetic and if applicable pharmacodynamics studies, followed by maintaining clinical effectiveness and security studies.
Additionally, with the addition of the articles directed to pharmacovigilance, it is aimed to provide close monitoring of the security of the biosimilar product in a continuous way after licencing.
Finally, it is stated in the Guideline that an application to the Authority can be made regarding the licencing process of biosimilar products if more detailed information is needed.
With the Amendments made in this Guideline regarding biosimilar products that had an increase in its importance in recent years, licencing processes have become more predictable for biosimilar drug manufacturers.