South Korean biopharma company Celltrion announced Friday that Truxima, its biosimilar drug referencing Roche’s Rituxan, has been granted marketing approval by Australia’s drug regulator.
Australia’s Therapeutic Goods Administration accepted Celltrion’s biologics license application to sell Truxima, approved for the treatment of conditions including rheumatoid arthritis and non-Hodgkin’s lymphoma, a rare form of cancer, according to Celltrion.
Truxima (Celltrion)
Biosimilars refer to cheaper, near-copies of cell-based biologic drugs whose patents have expired. Drugmakers around the world, including Celltrion, have embarked on the development of biosimilars, hoping to take away the lucrative profits from the world’s top-selling biologics.
With Truxima, Celltrion expects to take away sales of Rituxan (rituximab), also sold under the name MabThera, which raises around 115 billion won ($107.7 million) in annual sales in Australia.
Celltrion Healthcare, which distributes Celltrion’s drugs, is now in the process of selecting local marketing partners to take charge of launching Truxima in Australia.
In addition to Truxima, Celltrion’s Remicade-referencing biosimilar, Remsima, was also approved for sale in Australia in August 2015. Remsima is currently sold in the country via Celltrion’s partner Pfizer.
By Sohn Ji-young (
jys@heraldcorp.com)