The biopharmaceutical industry’s excitement for biosimilars has demanded the very best – and more – from analytical scientists and their tools. Here, Fiona Greer – long-time specialist in biopharmaceutical analysis – describes the need for instrumental orthogonality and the drive towards “fingerprint-like” comparative data. And Pat and Koen Sandra discuss the power of a rising analytical star in the field: two-dimensional liquid chromatography.
Chasing the Biosimilar Fingerprint
After finally breaking into the US market, biosimilars have created a real buzz in the industry, but demonstrating similarity can be daunting to say the least. Here, I share the tools of the trade and discuss the role of analytical science.
Fiona Greer |
Things have come on apace since the first biosimilar was given authorization in the EU in 2006. That was Omnitrope, a somatropin, a simple biosimilar product because it was a small non-glycosylated protein. The EU issued its first guidelines in 2005, but SGS M-Scan, as a company, had been working with biosimilar manufacturers prior to that. We were working a little bit ‘blind’ and were treating these molecules as you would any other protein, using the same techniques to interrogate the structure. Now, we have far better and more clearly drafted guidelines, and in addition to overarching directives and guidelines on quality, clinical and non-clinical requirements, there are product- or class-specific guidelines for certain molecules (1). The EU now has over 20 biosimilar products, including monoclonal antibodies (mAbs). Seven or eight years ago, people didn’t think we would ever have biosimilar mAbs – the analytical and clinical challenge appeared too great. Today, we have two products in the EU, etanercept and infliximab from two different manufacturers, and even have approval in the US.
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- European Medicines Agency, “Multidisciplinary: biosimilar”. Available at: bit.ly/1trteeH. Accessed June 13, 2016.
- World Health Organization, “Similar biotherapeutic products” (2014). Available at: bit.ly/1XiRR8W. Accessed June 13, 2016.
- World Health Organization, “Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs)”, (2016). Available at: bit.ly/1ULeTlr. Accessed June 13, 2016.
- FDA, “Information for Industry (Biosimilars)”, (2016). Available at: 1.usa.gov/1wAiQzJ. Accessed June 13, 2016.
- S Sutton, “The big break for biosimilars?”, The Medicine Maker, 6, PAGE NUMBERS TO BE ADDED (2015). Available at: bit.ly/25X2397