Strategies for generic/biosimilar market entry in Australia

The pharma/biopharma industry shouldn’t underestimate the importance of strategising to achieve early market entry for generics and biosimilars, says Naomi Pearce of Pearce IP.

Don’t start Australian FTO too late

Given the relatively small size of the Australian market compared with the EU and the US, freedom to operate (FTO) clearance in Australia is commonly deprioritised in favour of the more lucrative northern hemisphere markets. As a result, many early entry opportunities for Australia are superseded by the time Australia is considered. An early FTO addressing Australian patents—even at a high level—may reduce lost opportunities.

Beware of interlocutory injunctions in Australia

Unless the generic/biosimilar applicant has “cleared the way” in relation to any blocking patents in advance, they are very likely to be sued for patent infringement and to face an application for an interlocutory injunction which is rarely denied in Australia.