The success rate for small biotechs applying for regulatory approval from the EMA has risen by over 100% since 2016, which analysts partly attribute to increased access to sophisticated technology and funding.
According to a recent announcement from the EMA, the regulator greenlit a whopping 89% of applications for marketing authorization for new medicines from a micro-, small-, or medium-sized enterprise (SME) applicant last year. This figure dwarfs the 40% success rate for SMEs in 2016.
In 2020, 16 medicines developed by SMEs were approved by the EMA, of which half are treatments for rare diseases. This accounts for a fifth of last year’s EMA approvals of medicines for human use.
“SMEs play an important role in the development of new and innovative therapies in Europe and we are extremely pleased to see the increasing number of smaller companies bringing new medicines to market,” said Rafaèle Tordjman, founder of Jeito Capital, a Paris-based venture capital fund focused on biotech and biopharma.
The EMA classifies a company as an SME based on a range of criteria such as having up to 250 employees and an annual turnover of up to €50M.
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