Though coming from behind, China is cracking the seal on its biosimilar market and may even be poised to over-take the U.S. and Europe in less than a decade.
On February 22, 2019, China’s National Medical Products Administration (NMPA) approved the country’s first biosimilar, Rituximab from Shanghai Henlius Biopharmaceuticals Co Ltd.
The world’s first biosimilar, Sandoz’s Omnitrope, was approved in 2006 in Europe, but it took another seven years for larger biosimilar molecules, such as mAbs, to enter that market. Meanwhile, it was not until 2015 that the first biosimilar was approved in the U.S., and few biosimilars have been approved since.
Unlike this slow start in the U.S. and Europe, we believe China’s late arrival on the biosimilar global scene could turn out to be an advantage, as both regulators and industry players benefit from the accumulated knowledge learned by their western peers.