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European Biopharmaceutical Review

Revolution or Evolution?

Over the last 5-10 years, the biopharmaceutical industry predicted that the development of biosimilars would revolutionise the field of biologics by offering low-cost alternatives for many of these innovative therapies across multiple therapeutic areas. For example, when the Biologics Price Competition and Innovation Act was signed into law in the US as a subsection of the Affordable Care Act in 2010, it was accompanied by expectations of significant cost savings for both patients and the healthcare system. The expected savings over 10-15 years ranged from $25 billion to $250 billion, as put forth by the Congressional Budget Office and Express Scripts respectively (1).

The reality, however, is that the biosimilars market has developed much slower than expected Ė today, there are only three biosimilars approved in the US and 22 in the EU. To compete in the marketplace, biosimilars must be manufactured more efficiently to realise competitive pricing compared to their off-patent reference biologic. Developing these therapies is extremely challenging because they are required to have the same structure, activity and clinical efficacy and safety profile as the reference biologic, which adds significant complexity to the process.

Moreover, as the competition increases among biosimilars targeting the same reference biologic, companies are under further pressure to attain lower costs and maximise manufacturing flexibility. The high expenses associated with development therefore pose a significant hurdle for biosimilars manufacturers, who must compete on price.

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Guillaume Plane is the Global Development and Marketing Manager for Merck's Biodevelopment Services. He joined the company in 2012, bringing over 15 years of biotechnology experience spanning multiple specialities. Guillaume also serves as Visiting Professor at ESCP Europe, Toulouse Business School and IONIS School of Technology and Management. He received a masterís degree in biology and health from the University of Bordeaux, France, and an additional masterís degree in innovation and entrepreneurship from ESCP Europe. 
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