South Korea's Celltrion expects the Ministry of Food and Drug Safety to give it a local nod to sell a biosimilar of Rituxan/MabThera despite a patent challenge from Biogen that calls for a judgment as the approval process is underway.
The approval of a rituximab biosimilar would be the second for Celltrion in South Korea, pending a favorable ruling from the challenge known as a patent scope confirmation trial.
"We are waiting for MFDS' decision on the approval of CT-P10 (Truxima) which is expected to be announced this year," Gun Hyuk Lee, a spokesperson for Seoul-based Celltrion, said in an email to FiercePharmaAsia.
"Possible actions have been considered from all angles under legal review. We don't foresee any significant effect on the domestic approval and sales of CT-P10."
The Biogen challenge goes through South Korea's Intellectual Property Trial and Appeal Board that is part of patent linkage system that went into effect late last year following the South Korea-U.S. Free Trade Agreement in 2012.
The case may draw wider attention as an insight into how innovative pharmaceuticals may be treated under the Trans-Pacific Partnership trade pact concluded last year, particularly biologics. The TPP however will not be implemented until the U.S. Congress approves the pact as well as other national legislatures.
As well, another case last month that saw the Canadian unit of U.S.-based Amgen ($AMGN) challenge Samsung Bioepis biosimilar Brenzys over two of its patents for the autoimmune treatment Enbrel (etanercept).
In this particular case in South Korea, it covers the Biogen's original anti-CD20 antibody developed with Roche ($RHBBY) Rituxan/MabThera (rituximab), which is the reference drug. Celltrion has contested the move to challenge the patent.
Earlier this week, Hsinchu-based Taiwan firm JHL Biotech won a nod for clinical trials of a biosimilar of rituximab to treat rheumatoid arthritis from the U.K.'s Medicines and Healthcare Products Regulatory Agency, where the patent expired in 2013 and marking what it says is a milestone for a monoclonal antibody biosimilar candidate from Greater China.
However, in Asia besides Celltrion, India's Dr. Reddy's Laboratories already sells a biosimilar version in India.