Australian Regulators Recommend Biosimilar Substitution without Notification

Australian pharmacists could soon substitute a biosimilar infliximab for its reference product without prescribing physicians’ –or even patients’—knowledge. The Department of Health’s Pharmaceutical Benefits Advisory Committee has recommended adding an infliximab biosimilar to the country’s list of approved drugs as an equivalent to its reference product. Known as “a-flagging,” the move would allow pharmacists to […]

Battle in Australia over access to cancer drugs

Access to cancer drugs in Australia is coming to a head after a bitter tit for tat over a pharma push to fast-track oncology treatment. The industry is calling for a more flexible and fast-tracked approach to approving new cancer drugs, claiming the current system is outdated. Australia ranks 18th out of 20 comparable OECD […]

Europe and Australia Reshuffle on Generics, Biosimilars

Europe and Australia are reassessing, recalling and reflecting on biosimilars and generic medications. The countries’ recent actions suggest that, despite pharmaceutical and regulatory advances, producing and regulating safe, effective follow-on medications remains a challenge. Australia Nixes Biosimilar Naming Plans Last month, Australia’s Therapeutic Goods Administration nixed plans to implement a new naming system for biosimilar […]

Australian Regulator Hits Restart on Plan to Name Biosimilars

Australia’s medicines regulator, the Therapeutic Goods Administration (TGA), has announced it will no longer implement a planned update to the way in which it names biosimilar products following a proposal by the World Health Organization to change a naming standard on which Australia relied for its policy. More at RAPS Regulatory Focus