?Mousa A. Qarawi, Sumia S. Mohamed, Babiker M. El-Haj and Abu-Al-Futuh I.M.


Recombinant protein therapeutics were first introduced in the 1980s. Patents for many approved recombinant protein therapeutics have either expired or are about to expire. Thus the market is open for generic versions, referred to as „biosimilars‟ (European Union) or „follow-on protein products‟ (United States). Biosimilars offer one way of widening access and enabling better value to be obtained from the money spent on healthcare. Current analytical methods cannot characterise biosimilar recombinant protein therapeutics sufficiently in order to confirm structural equivalence with reference products due to their complex high-molecular-weight three-dimensional structures, thus the term biosimilar rather than generic is used. In addition, recombinant protein therapeutics are produced by living cells, production and purification methods can affect folding/glycosylation profile in the biosimilar product compared to the reference product.The foundation of approval for a new recombinant protein therapeutic by major regulatory bodies is traditionally a large clinical program to test safety and efficacy of a novel treatment. By contrast, the foundation of approval for a biosimilar recombinant protein therapeutic is a large analytical program to test similarity in molecule structure to the previously approved reference product. The regulatory approval pathways for biosimilar and biobetter (improved version) of therapeutic products are different and the sponsors of the application for a new product must decide which route they need to take prior to submitting their application. Data from pre-authorisation clinical studies are usually insufficient to identify long term/rare adverse effects. Therefore, clinical safety of biosimilars must be monitored closely on an ongoing basis during the post approval phase including continued benefit-risk assessment. Any specific safety monitoring imposed on the reference medicinal product or product class should be adequately addressed in the pharmacovigilance plan of the biosimilar. There is a rapid change in biosimilar market and legislation due to several unresolved issues, including substitution, naming and labelling. Postmarketing pharmacovigilance can certainly help in addressing some of these issues. Greater awareness of the potential differences between products will enable pharmacists to play a very important role in providing information for both prescribers and patients in order to insure the safe, effective and cost-effective use of biosimilars.

Keywords: Biosimilars, generics, biobetter, pharmacovigilance.

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