Australia's TGA registers Hospira's Inflectra

Australia's Therapeutic Good Administration has registered mAb biosimilar Inflectra (infliximab) from Hospira ($HSP), the company said in a press release, noting it sets the stage for reimbursement under the country's Pharmaceutical Benefits Scheme. In June, Australia drew flak from the U.S.-based Alliance for Safe Biologic Medicines on a proposal that would see pharmacies in some cases substitute biosimilars for originator drugs. However, the government has since refined guidelines from the Pharmaceutical Benefits Advisory Committee on how biosimilars could be "a"-flagged, or equivalent to the originator drug, allowing them to be substituted at the pharmacy level. In Australia, Inflectra was registered for eight inflammatory conditions--similar to those for the original drug, Johnson & Johnson ($JNJ) and Merck & Co.'s ($MRK) rheumatoid arthritis drug Remicade. Hospira said PBS reimbursement on Remicade last year was "more than $100 million." It however did not offer a savings estimate, but said a "biosimilar has the potential to deliver a 20% to 30% reduction in the price paid for the therapy." Earlier this week, South Korea-based Celltrion said it had gained approval to sell Remsima, its biosimilar of Remicade, in Australia, the Korea Herald reported. The company is now following on in Asia after the launch of Remsima, also known as Inflectra, across Europe, including in the U.K., France and Germany in partnership with Hospira. Release