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European Biopharmaceutical Review

Editors Letter

The first documented administration of insulin as an intervention in diabetes was in 1922. A relatively crude extract from bovine pancreas was injected into a 14-year-old boy in Toronto, and, although the first injection was not entirely without complications, this intervention ultimately saved his life. The subsequent impact of this discovery on the lives of countless patients and our industry has been, to say the least, transformational. Fast forward a century to 2022, and the biosimilars of biopharmaceutically manufactured, synthetic insulins will likely be mainstay therapies for diabetes, as Syneos Health's Rafal Kokolus, Dr Doug Niven, and Rohit Sood discuss how the illness joins the list of conditions for which all stakeholders are transitioning towards biosimilar adoption.

If the rapidly expanding and often complex biosimilars universe is not quite fully in focus for you yet, then articles in the summer 2018 edition of EBR will provide excellent overviews of the state-of- the-art in defining by sequence (Dr Richard Easton and Dr Andrew Reason at BioPharmaSpec) and protecting via optimal patent and commercial strategies for these high-value ‘affordable’ biological therapeutics, distinct in sequence and synthesis, yet ‘highly similar’ in efficacy and safety to first generation proprietary forms of which they are effectively ‘functional generics’ (Boult Wade Tennant’s Jennifer O’Farrell, and Finnegans’ Sanya Sukduang and Thomas J Sullivan).

The first ever biosimilar drug product approval (by the EMA in 2006) was for a hormone therapy, omnitrope (somatropin), although the first biosimilar insulin hormone was only approved as recently as 2014. Antibody biosimilars, ‘adopted’ by the EMA and FDA more recently, have made much more ‘noise’, arguably because of the premium priced proprietary market pioneers they can replace. Three articles in this edition of EBR focus on antibodies as the targeting component of antibody-drug conjugates (ADCs) in cancer therapy (the team from Aptamer Group, and Dr Neil Butt from IONTAS). ADCs are an increasingly important drug class in oncology, evidenced by the fact that, according to Professor Andreas Pahl from Heidelberg Pharma, more than 70 are now in clinical trials.

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Dr Deborah O’Neil, Chief Executive and Scientific Officer, NovaBiotics Ltd
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Dr Deborah O'Neil
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