Keeping a Finger on the Biosimilar Pulse
The rise of biosimilars is great news for overburdened healthcare systems, but it’s a very different proposition to a simple generic. Here, I discuss some of the many challenges – legal, regulatory, non-clinical and clinical – that manufacturers face when developing biosimilar products for global markets.
Fiona Greer |
The first approved recombinant DNA-produced biologic drug was human insulin in 1982. Since then, the global biopharmaceutical market has grown to an estimated $163 billion (Dec 2014) (1), a significant proportion of which is made up of monoclonal antibody (mAb) products. In the EU and US, there are over 30 novel approved therapeutic mAbs, with many more currently going through the application process. The market for these products is forecast to reach nearly $58 billion by 2016 and includes best sellers such as Avastin, Herceptin, Humira, Remicade and Rituxin, which account for over half of all global revenues.
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