The guide – written in collaboration with the European Commission and published below – aims to provide healthcare professionals with information on the science and regulation underpinning the use of biosimilars and was launched at a stakeholder conference on biosimilar medicines in Brussels last week.
“Today, biosimilars are an integral part of the effective biological therapies available in the EU,” the EMA’s executive director Guido Rasi said. “Given the role of healthcare professionals on the front line of patient care, it is vital that they have access to reliable information on these medicines: what they are and how they are developed, approved and monitored.”
The 37 page document contains information covering the definition of biosimilars, the development and approval process, and the data included in the prescribing information and EMA assessment reports.
It also talks about the safety of biosimilars, based on over a decade of real-world evidence.
“Over the last 10 years, the EU monitoring system for safety concerns has not identified any relevant difference in the nature, severity or frequency of adverse effects between biosimilars and their reference medicines,” the report says.
Since the approval of the first biosimilar in 2006 – Sandoz’s Omnitrope , a version of Pfizer’s growth hormone Genotropin (somatropin), the Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended 27 biosimilars for use in the EU, the highest number of biosimilars worldwide.
As a comparison, the first biosimilar in the US came almost a decade later when Sandoz’ version of Amgen’s Neupogen (filgrastim), Zarxio, was approved in 2015. To date there are four biosimilars approved by the US FDA.
“The expertise acquired over the last 10 years has enabled EU regulators to integrate experience-based knowledge with the initial science driven concept,” the EMA states.
Extrapolation
Such experience has helped shape approval requirements, the Agency adds, as well as establishing practises relating to extrapolation.
“If a biosimilar is highly similar to a reference medicine and has comparable safety and efficacy in one therapeutic indication, safety and efficacy data may be extrapolated to other indications approved for the reference medicine,” the documents says.
“Extrapolation of data to other indications is always supported by scientific evidence generated in robust comparability studies (quality, non-clinical and clinical).”