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Fields & Applications Pharma & Biopharma

Biosimilar Breakdown

Chasing the Biosimilar Fingerprint

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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  1. European Medicines Agency, “Multidisciplinary: biosimilar”. Available at: bit.ly/1trteeH. Accessed June 13, 2016.
  2. World Health Organization, “Similar biotherapeutic products” (2014). Available at: bit.ly/1XiRR8W. Accessed June 13, 2016.
  3. World Health Organization, “Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs)”, (2016). Available at: bit.ly/1ULeTlr. Accessed June 13, 2016.
  4. FDA, “Information for Industry (Biosimilars)”, (2016). Available at: 1.usa.gov/1wAiQzJ. Accessed June 13, 2016.
  5. S Sutton, “The big break for biosimilars?”, The Medicine Maker, 6, PAGE NUMBERS TO BE ADDED (2015). Available at: bit.ly/25X2397

About the Author

Fiona Greer

Fiona is Life Sciences Global Director at SGS Labs. She has always been attracted to the investigative nature of analytical science, initially studying Forensic Science and completing a PhD in Protein Chemistry looking at plant toxins. In the early 1980s, she joined a pioneering start-up company to utilize biological mass spectrometry to interrogate the structure of proteins and glycoproteins for the emerging biotechnology industry. With over 35 years of experience in this field, she has seen biological drugs, particularly monoclonal antibodies, become the blockbusters of the pharma world.

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