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Chapter 1 The era of biological medicines - IGBA
www.igbamedicines.orgA biological medicine is a mixture of closely related variants of the same protein. 1. References: 1. EC/EMA. Biosimilars in the EU – Information guide for Healthcare Professionals 2017.
Biosimilars in the EU
www.ema.europa.euSummary Since the EU approved the first biosimilar medicine (‘biosimilar’) in 2006, the EU has pioneered the regulation of biosimilars. Over the past 10 years, the EU has approved the highest number
Biosimilars in the EU
www.ema.europa.euneutralise the medicine’s activity and reduce its efficacy. Thus, potential immunogenicity needs to be always evaluated for all biological medicines. Natural variability is inherent to all biological medicines and strict controls are always in place during manufacturing to ensure that it does not affect the way the medicine works or its safety. 7