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European Biopharmaceutical Review

Robust Method Development for Biologics and Biosimilars




Biological medicines have transformed patient care across a number of serious and debilitating disease areas, including cancers, inflammatory diseases, and immunological conditions. These complex and costly medicines represent a highly competitive and rapidly evolving area of the pharmaceutical industry. In particular, therapeutic antibodies such as Humira® (adalimumab) are now among the top-selling drugs across the globe. Robust analytical data are critical in ensuring the development of efficacious medicines that meet stringent regulatory standards for patient safety. Bioanalytical platforms, tools, and reagents that offer exceptional levels of specificity are essential in ensuring the timely delivery of next-generation biologics.

Biological Medicines and Biosimilars

Biological medicines are highly complex protein-based drugs, made in or derived from living organisms. These cutting-edge medicines are designed to mimic molecules found naturally in the body (e.g., enzymes, antibodies, hormones). Therapeutic antibodies and antibody fragments represent a swiftly expanding class of large molecule medicines that offer high specificity, affinity, and potency.

Biosimilars (highly similar versions of originator drugs) are introduced to the market following expiry of originator patent exclusivity. They take less time to bring to market, are generally lower in cost compared with originator medicines, and present an increasing commercial opportunity for pharma companies as well as offering the potential for wider patient access to this important class of medicines. As a consequence of their growing success, the ongoing safety and efficacy of these medicines is very much under the spotlight. A large proportion of the data supporting the use of biosimilars in different clinical indications are extrapolated from originator evidence. This is heavily reliant on the biosimilar developer/manufacturer proving that their ‘copy’ is highly similar in terms of structure and function. Bioanalytical data form a critical part of the totality of evidence for biosimilar approval and use in clinical practice.

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Amanda Turner is Product Manager for Custom Antibody Products at Bio-Rad Laboratories, Inc, based in Oxford, UK. Her primary responsibilities are the new product development and marketing for the Custom HuCAL Antibody Generation Service and the Anti-Biotherapeutic Antibody portfolio. She received an MA in Biochemistry from the University of Oxford, UK, and then pursued a career in sales and marketing. She has held technical sales, business development, and marketing positions in several companies in the life sciences industry, before joining Bio-Rad in 2012.
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