Biogen is trying to halt Celltrion from selling a rituxima copycat biosimilar (CT-P10) in South Korea by seeking a patent scope confirmation trial. But Celltrion said it doesn’t expect Biogen’s move to have a significant impact and foresees domestic regulatory approval this year.
Originally invented by Biogen, CT-P10 is a candidate biosimilar of rituximab. In 2014, rituximab recorded US$7.78 billion in global sales. Its patents already expired in Europe in December 2013 and will expire in the U.S. in September 2016. Although the patents on rituximab in Korea expired in October 2013, its collateral patents, including five formulation and use patents, which are still protected.
Biogen filed a request for patent examination by Intellectual Property and Appeal Office in Korea, contending that the company holds patent rights for MabThera and that Rituxima may infringes on its rights.
According to Celltrion, Rituxima is currently in the third-stage clinical trials and the company filed a request for Ministry of Food and Drug Safety (MFDS) approval.
As such, the biosimilars sector, a burgeoning area as a cost-saving alternative in the drug market, has immeasurable market growth outlook due to increasing patent expirations of key biological drugs and explosive demand in an aging society.
Nevertheless, companies like Celltrion still face a struggle against legal and political lobbying from some big pharmaceuticals and biotech groups against their entry.
Remsima is another biosimilar that Celltrion launched in Europe in February last year and is now sold to 40 countries worldwide. But the biggest market by far — the U.S. — so far remains elusive. The U.S. Food and Drug Administration (FDA) panel to review Remsima was postponed in February last year, leaving the timetable for its potential US entry in doubt.