Celltrion's Truxima wins approval in Australia

Truxima

By Park Jae-hyuk

Celltrion said Sunday it has recently won approval from the Australia's Therapeutic Goods Administration for the sale and marketing of Truxima, the Korean biopharmaceutical firm's cheaper biosimilar copy of Rituxan which was developed by Biogen and marketed by Roche.

Biosimilars are officially approved copycat medicines developed on patents of the original biopharmaceuticals when the patents expire. Truxima can be used for the treatment of various diseases, including rheumatoid arthritis and non-Hodgkin's lymphoma, a type of leukemia.

Roche's original drug has allowed the multinational pharmaceutical to post $107.7 million in annual sales in the Australian market. With Truxima, Celltrion expects to overtake the sales of Roche's Rituxan, which is also sold under the name MabThera.

Following the Australian drug regulator's approval, Celltrion Healthcare, a Celltrion's affiliate in charge of distribution and marketing of Celltrion's drugs in overseas markets, is now looking for a partner in Australia. The company said it will decide on a specific schedule for the introduction of Truxima there, after choosing its local partner.

Truxima has become Celltrion's second drug to be released in Australia. In August 2015, Celltrion won approval for its Remsima and has sold the biosimilar for treatment of autoimmune diseases through a partnership with Pfizer.

“For more patients in Australia to benefit from high-quality biosimilars at affordable prices, we will try our best introduce our products there as quick as we can,” a Celltrion official said.