New feature “Biosimilar medicines” introduced in the Medicinal Product Register of Latvia

New feature “Biosimilar medicines” introduced in the Medicinal Product Register of Latvia

In accordance with the Cabinet of Ministers regulation regarding the procedure for prescribing recipes, the pharmacist or pharmacist’s assistant, upon dispensing biological medicines, shall indicate the serial number of medicines dispensed. However, this is only one of the conditions that healthcare professionals are required to comply with when prescribing biological or biosimilar medicines. Stricter pharmacovigilance measures have been applied to these medicines because special attention is being paid to the risk management for these medicines. The objective of pharmacovigilance is to identify changes in the safety profile of medicines as early as possible in the life-cycle of these medicines, to conduct research and implement risk minimisation measures.

In order to facilitate the availability of information regarding the potential biological origin of medicines and compliance with the aforementioned regulation to healthcare professionals, as well as to allow other users of the Medicinal Product Register of Latvia to better orient themselves among the medicinal products included in the register, the State Agency of Medicines introduces a new feature “biosimilar medicines” that will be visible beside the name of the active substance.

From now on the “biosimilar medicines” criteria will also be available as a search parameter in the advanced search form of the Medicinal Product Register of Latvia.

By improving the search function of the Medicinal Product Register of Latvia, the State Agency of Medicines aims to make the daily work of healthcare professionals more convenient by facilitating the search for information regarding medicines and the choice regarding the most appropriate therapy for patients.

Biological medicines are immunological preparations – vaccines, serums; medicines derived from human blood or plasma and advanced therapy medicinal products mentioned in the Regulation No. 1394/2007 – gene therapy, somatic cell therapy, products of tissue engineering. Unlike other medicinal products, biological medicines form large and complex molecules that are derived from living cells and are relatively unstable, and the safety data at the time of marketing authorisation are very limited, taking into account the specifics of the use of these medicines.

Similar biological medicinal products or biosimilar medicines are biological medicines that are essentially similar to the reference medicinal product with regard to structure, biological activity, efficacy, safety and immunogenicity.