Preparing for Biosimilars : Regulatory and management issues, Current regulatory and market environment for biosimilars in the world and in Hungary

Absztrakt (kivonat)

Nine years ago, in 2005 the European Medicines Agency (EMA) was the first regulatory body to issue guidelines on biosimilars in the European Union (EU). This paper describes the current regulatory policy for approving biosimilars both in the European Union and in Hungary, which is a Member State for ten years by now. This thesis examines regulatory and management issues using information towards the pharmaceutical biotechnology industry (biopharmaceutical sector) focusing on Similar Biological Medicinal Products (biosimilars). Production of such products is expected to meet global demand, promote market competition, maintain the incentives for innovation, and sustain the healthcare systems. Biological medicines are at the top of the treatment guidelines recommended for complex diseases with high death and disability burdens. The objective is to examine information related to biosimilars to define their potential impact on competition in the biopharmaceutical market. The paper serves to review and analyze the experience of biosimilars in the EU, as well as the obstacles and opportunities that biosimilars face in Hungary by examining current trends in biosimilars and the potential implications on the future of biosimilars.