Samsung Bioepis’s Humira Biosimilar Hadlima was approved by the Therapeutic Goods and Administration in Australia.
Samsung Bioepis’s has requested the approval of all the indications for Humira. Later, the sponsor has restricted the removal of other indications during the evaluation process.
The approval is based on Phase 3 52 weeks trial. The study compared the safety and efficacy of Hadlima with Humira. The studies were conducted in accordance with the European and United States guidelines.
Hadlima was available as Imraldi in Europe. It is under the evaluation process in Canada and was not submitted to the US FDA in the USA.