Biosimilars: EMA Guidance and EU Regulations
EMA guidance for biosimilars supports the development and regulatory assessment of biological medicines that are highly similar to an existing biological medicine, known as the reference medicine. Biosimilars must demonstrate that there are no clinically meaningful differences from the reference medicine in terms of quality, safety and efficacy.
The European Union has established a comprehensive regulatory framework for the development, evaluation and authorisation of biosimilar medicines. The European Medicines Agency (EMA) provides scientific and regulatory guidance for developers seeking marketing authorisation in the EU.
EMA Guidance for Biosimilars and Regulatory Assessment
EMA guidance for biosimilars establishes scientific principles and regulatory requirements for demonstrating biosimilarity.
The regulatory assessment is based on the totality of evidence generated during the biosimilar development programme.
Current scientific and regulatory information is available from the European Medicines Agency’s biosimilar medicines overview.
Biosimilar Comparability Exercise
Development of a biosimilar involves a comprehensive head-to-head comparability exercise with the reference medicine.
The comparison begins with detailed quality, analytical and functional studies. The results of these studies help determine the extent of additional nonclinical and clinical evidence required to demonstrate biosimilarity.
Quality Assessment
Extensive analytical characterisation is fundamental to biosimilar development. The biosimilar and reference medicine are compared in areas such as molecular and biological characteristics, purity, manufacturing consistency and biological activity.
Because biological medicines are produced using living systems, some natural variability is expected. The objective is therefore to establish a high degree of similarity rather than molecular identity.
Nonclinical and Clinical Development
The extent of nonclinical and clinical studies required for a biosimilar depends on the results of the comparability exercise and the characteristics of the product.
Clinical development may include comparative pharmacokinetic and pharmacodynamic studies and, where necessary, additional studies addressing efficacy, safety and immunogenicity.
The purpose of these studies is to resolve remaining uncertainty about biosimilarity rather than independently re-establish the benefits of the reference medicine.
EU Marketing Authorisation for Biosimilars
EMA’s scientific committees evaluate marketing authorisation applications for the majority of biosimilar medicines in the EU.
Applicants must provide sufficient evidence demonstrating that the proposed biosimilar is highly similar to the reference medicinal product and that there are no clinically meaningful differences in quality, safety and efficacy.
Pharmacovigilance
After authorisation, biosimilar medicines are subject to pharmacovigilance and safety monitoring requirements in the same way as other medicinal products in the EU.
Marketing authorisation holders must monitor safety information, comply with applicable pharmacovigilance requirements and maintain appropriate risk-management measures.
Interchangeability
EMA and the Heads of Medicines Agencies have stated that biosimilars approved in the EU are scientifically interchangeable with their reference medicines and with other biosimilars of the same reference medicine.
However, decisions concerning prescribing practices and automatic substitution at pharmacy level remain the responsibility of individual EU Member States.
The EU biosimilar framework therefore combines comprehensive comparability studies, scientific assessment, regulatory review and continuing safety monitoring to ensure that authorised biosimilars meet established standards for quality, safety and efficacy.
For additional regulatory topics, explore ClinSkill’s Regulatory Affairs Knowledge Base.
You may be interested in the programs below:
