Sandoz’s Bourdage Makes Case For Tailored Biosimilar Pathways

Current Approach Of Phase III Studies ‘Is No Longer Justified In Many Cases’

A strong case exists for a more tailored approach to biosimilars development that could increase regulatory efficiency and broaden access, Sandoz’s head of biopharmaceuticals, Pierre Bourdage, tells Generics Bulletin in an exclusive interview.

Pierre Bourdage, Sandoz head of biopharmaceuticals
Sandoz’s Pierre Bourdage sets out the case for tailored biosimilar development • Source: Sandoz

With 2021 marking 15 years since the first biosimilar, Sandoz’s Omintrope (somatropin), was approved and launched in the EU, the company’s head of biopharmaceuticals, Pierre Bourdage, has reflected on the global progress made so far on biosimilars – as well as the opportunities that exist for future evolution – in an exclusive two-part interview with Generics Bulletin.

“Since Sandoz started its first biosimilar development program in 1996, we have seen many advancements in science and technology, also...

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