Abstract
Biopharmaceuticals are one of the fastest-growing sectors in the biotechnology industry. Within the umbrella of biopharmaceuticals, the biosimilar segment is expanding with currently over 200 approved biosimilars, globally. The key step towards achieving a successful biosimilar approval is to establish analytical and clinical biosimilarity with the innovator. The objective of an analytical biosimilarity study is to demonstrate a highly similar profile with respect to variations in critical quality attributes (CQAs) of the biosimilar product, and these variations must lie within the range set by the innovator. This comprises a detailed comparative structural and functional characterization using appropriate, validated analytical methods to fingerprint the molecule and helps reduce the economic burden towards regulatory requirement of extensive preclinical/clinical similarity data, thus making biotechnological drugs more affordable. In the last decade, biosimilar manufacturing and associated regulations have become more established, leading to numerous approvals. Biosimilarity assessment exercises conducted towards approval are also published more frequently in the public domain. Consequently, some technical advancements in analytical sciences have also percolated to applications in analytical biosimilarity assessment. Keeping this in mind, this review aims at providing a holistic view of progresses in biosimilar analysis and approval. In this review, we have summarized the major developments in the global regulatory landscape with respect to biosimilar approvals and also catalogued biosimilarity assessment studies for recombinant DNA products available in the public domain. We have also covered recent advancements in analytical methods, orthogonal techniques, and platforms for biosimilar characterization, since 2015. The review specifically aims to serve as a comprehensive catalog for published biosimilarity assessment studies with details on analytical platform used and critical quality attributes (CQAs) covered for multiple biotherapeutic products. Through this compilation, the emergent evolution of techniques with respect to each CQA has also been charted and discussed. Lastly, the information resource of published biosimilarity assessment studies, created during literature search is anticipated to serve as a helpful reference for biopharmaceutical scientists and biosimilar developers.
Highlights
Biologics or biotherapeutics are rDNA products used to diagnose, prevent, treat, and cure medical conditions and include a diverse category of products
Following the patent cliff of certain innovator products and the growing support from the major regulatory agencies, there has been a steady increase in the number of biosimilar approvals
In alignment with the International Council for Harmonization (ICH) guidelines, the European Medicines Agency (EMA)’s “Guideline on Similar Biological Medicinal Products” states that similarity to the innovator needs to be established in terms of quality characteristics, biological activity, safety, and efficacy based on a comprehensive, head-to-head biosimilarity exercise for characterization of the quality of the DP and the approval is subjected to the totality-of-evidence presented (EMA, 1996, 1999, 2005; CHMP, 2005, 2014)
Summary
Biologics or biotherapeutics are rDNA products used to diagnose, prevent, treat, and cure medical conditions and include a diverse category of products (i.e., proteins, enzymes, peptides, vaccines to name a few). As the innovator (aka originator/reference) molecule reaches patent cliff, it paves way for commercialization of biosimilars which are “highly similar” to the innovator in terms of structure and function, notwithstanding minor variations in clinically inactive components and should have no clinically meaningful differences in terms of safety, purity, and potency of the drug product (DP2) (USFDA, 2019). This needs to be thoroughly characterized during product development. Definitions and meanings of domain specific terminology have been listed in Supplementary Table S2
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