European Guide for Prescribers Assures Safety and Effectiveness of Biosimilars


The European Medicines Agency (EMA), working with the European Commission (EC), has released a guide for healthcare professionals that contains essential information on biosimilars, including evidence supporting their safety and an explanation of the regulatory process.

According to an EMA press release, the guide was presented at the EC’s 3rd annual stakeholder event on biosimilars, which was attended by providers, patients, payers, and pharmaceutical manufacturers. Juan Garcia Burgos, MD, head of the EMA’s public engagement department, introduced the guide as a “comprehensive reference material” representing “a joint effort to support information and continuous education of healthcare professionals in the EU, and facilitate dialogue with patients.”

Biosimilar uptake in Europe has been significantly quicker than in the United States, as 28 biosimilars have been approved by the EMA since 2006. Still, the information in the newly released guide indicates that some providers may have misconceptions about biosimilars or be apprehensive about prescribing them.

One section of the guide uses a table to compare and contrast the 2 drug groups and explains why biosimilars are not the same as generic medicines. For instance, with generic drugs it is “generally possible to obtain exactly the same molecule,” while with biosimilars it is “possible to reproduce the molecule to a high degree of similarity due to unique biomanufacturing methods and natural biologic variability.” Biosimilars also must undergo a more rigorous testing protocol compared with generics, including comparability studies and safety and efficacy trials,.

This strenuous regulation of new biosimilars, according to the guide, has contributed to the drugs’ safety. “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 biosimilar medicines and their reference medicines,” the guide says, also noting that none of the biosimilars have ever been withdrawn or suspended for safety or efficacy reasons.

The increasing use of biosimilars could have important implications for drug availability. The lower price point of biosimilars, due to market competition effects and lessened development expenses, can save money for healthcare systems and patients. “Having more treatment alternatives available is expected to improve patients’ access to biological medicines with proven pharmaceutical quality,” per the guide.

In addition to advice on switching and interchangeability, the guide includes tips on patient communication and links to resources for additional information. The European Union has been at the forefront of biosimilar development and regulation, according to the guide, which explains how the EMA’s regulatory framework has been influential in developing approval guidelines in the United States, Australia, and by the World Health Organization.

“Today, biosimilars are an integral part of the effective biological therapies available in the EU,” said professor Guido Rasi, executive director of EMA, in the press release. “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.”

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