Invited Speaker

Biosimilar medical agents approval in the European Union – a short but fascinating story
Michal Nowicki
Poland

Biotechnology has already allowed us to produce numerous medicines that opened a new era in modern pharmacotherapy. Biotech product has helped us to combat many diseases which remained incurable in the era of conventional natural or chemical medicines. Oncology, infectious diseases, rheumatology and kidney diseases remain most important clinical areas for the current and future clinical application of biotechnology medicines. Biotech drugs are generally safe and well-tolerated and adverse reactions such an immunogenicity (e.g. pure red cell aplasia after recombinant epoetin) are rare. The recent expiry of patent protection for many original biological drugs has led to the development of products known as biosimilars (in Europe) or follow-on-biologics (in the USA). Recently, regulatory guidelines for the approval and post-marketing tracking of biosimilar medicinal products have been introduced by the European Commission and European Medicinal Agency (EMEA) but most of the European countries lack the specific approval pathways for biological drugs and biosimilars. Since 2006, several biosimilar medicines have been approved by the European Union. The first approved agents of this new class included recombinant human growth hormone, recombinant epoetin alpha, and filigrastim (G-CSF). One of the early submissions was rejected (interferon). Several agents are currently under approval process. The approval of biosimilar medicinal products raised several key issues such as safety, pharmacovigilance, automatic substitution, naming, labeling and prescription rules.