المملكة: “Food and medicine" Establishes strict requirements for the approval of biosimilars
The new guide, which represents a reference framework for pharmaceutical agencies and developers, provides a detailed explanation of the biosimilarity protocol, the mechanisms for selecting the reference product, and the requirements for comparison between Biosimilars and reference products, in addition to the scientific and regulatory foundations for their adoption in the Kingdom.
The principle of biological similarity
The authority explained in its guide that the principle of biosimilarity represents the basic foundation of the process of approving biosimilar medicines, and is based on developing a medicinal product that contains a bioactive substance that is highly similar to the previously approved reference product, in terms of qualitative, structural and functional characteristics, without any clinically significant differences between them.This means that the previously proven effectiveness and safety results of the reference product can be relied upon when approving the similar bioactive medicine, without the need to re-prove them clinically. As long as complete structural and functional similarity is confirmed.
The authority noted that a slight variation in biomolecules between production batches is normal in all biological products, given the multiplicity of organisms used in manufacturing and the complexities of biological processes. Therefore, biosimilarity must be demonstrated through comprehensive comparison exercises covering all structural, functional and clinical aspects, to ensure that any differences remain within acceptable limits that do not affect safety or effectiveness.
An integrated regulatory framework for the approval of biosimilars
The Authority confirmed that the guide complements the Technical and regulatory guidelines published on its website, including the regulatory framework for drug approval, quality requirements guidelines, bioequivalence studies, clinical trial systems, human drug data submission requirements, in addition to pricing rules and priority review guidelines.The guide obliges developers to prepare a marketing authorization application file that includes detailed data on quality, manufacturing, and chemical control, as well as the results of non-clinical and clinical comparisons to prove similarity to the reference product.
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It also stresses the importance of an accurate and comprehensive characterization of the structural and functional properties using advanced analytical techniques, with a clear understanding of the mechanism of action of the active biological substance, and developing an approved comparative protocol to ensure the stability of production quality across different batches.
The biosimilarity protocol and criteria for selecting the reference product
The guide considered the biosimilarity protocol to be one of the essential elements in the development and evaluation process, as it guarantees an accurate scientific design and high credibility of the results.
The protocol requires Identify the reference product accurately according to specific conditions, including the expiry of the intellectual protection period, obtaining a full marketing license, and providing a reliable record in terms of safety and effectiveness.
Comparisons are required to be made over a sufficient number of batches of the reference and similar product, including at least 15 batches of the reference and 10 batches of the biosimilar, in addition to developing a detailed plan to assess risks and identify critical qualitative characteristics that have a clinical impact.
The Authority stressed the importance of communication. The Authority indicated that biocomparison exercises represent the basic foundation in evaluating biosimilars, through which similarity with the reference product is demonstrated in all aspects, from quality and composition to safety and effectiveness.
These exercises have witnessed great development thanks to the progress in molecular analysis techniques, which has reduced the need for Some extensive clinical studies.
The Authority explains that advanced analytical and functional data, along with kinetic and pharmacodynamic studies, can be sufficient to prove similarity in most cases, provided that scientific justifications are available for this.
