Authorised medicinal products produced using recombinant DNA technology

Abstract

Background: The use of genetically modified organisms and technologies such as recombinant DNA (rDNA) technology, enabled opportunities to produce new medicinal products and novel treatments which target previously untreated conditions, such as the production of insulin for diabetes. Along the years, numerous therapies were approved which address unmet therapeutic needs. Purpose: The aim of this study was to identify products produced using rDNA technology which are approved within the European Union. Method: A list of products, which included biological medicines, biosimilars and vaccines, produced using rDNA technology and approved within the European Union was identified using the European Medicines Agency website. The inclusion criteria used for the study were that they are currently approved, are for human use, and produced using rDNA. The identified products were categorised according to the active pharmaceutical ingredient, the indication for use and the date when approval was granted. Results: A total of 63 products approved for human use were identified. The oldest product produced using rDNA technology to be granted marketing authorisation and which is still currently authorised within the EU is insulin lispro (Humalog), which was approved in 1996. The most recently approved product was the biosimilar medicine teriparatide (Kauliv) which was granted approval in January of 2023 and is indicated for osteoporosis. The highest number of biological products to be authorised was observed in 2002, with 6 products being granted approval, whereby 5 of the products were approved for use in diabetes mellitus and 1 product was approved for immunization against Hepatitis A and B. This was followed by 2014 and 2015 with 5 products being approved in each year. Out of the currently approved products, no products were granted authorisation in 1998, 2008, 2010 and 2011. The authorised products are used for 15 conditions. The condition with the highest number of approved products was Haemophilia A and B (n=15), followed by diabetes mellitus (n=14) and Hepatitis A and B (n=10). While asthma and chronic urticaria, short bowel syndrome and obesity have 1 approved product each. Conclusion: The amount of approved products produced using rDNA technology varied along the years and consisted of biological products, biosimilar medicine and vaccines. Although conditions such as diabetes have a good number of approved products, there are still conditions which require the availability of additional therapeutic options.