Oldham believes that Europe should have a huge competitive advantage over the rest of the world in the field of biosimilar products, with the United States and Japan both lagging behind in the regulatory stakes. "The implementation of the EU guidelines governing biosimilar R&D must continue along the solid science-based agenda laid out in the new EU medicines legislation," he said. "It must bear fully in mind the known characteristics of these products and the public health benefits at stake."

Sarah Houlton, PhD, is Pharmaceutical Executive's global correspondent. She can be reached at sarah@owlmedia.co.uk