While the Food and Drug Administration released draft guidance on regulations for biosimilars in February 2012, the final regulations have yet to appear. But already, everyone from analysts to trade groups to drug makers is preparing for a time when knock-off versions of biotech drugs will become available.
A new report sheds light on some of the opportunities and challenges that exist in follow-on biologics, arguing that their opportunity to generate value depends on factors like the speed of development, clarity of regulation, ease of access and the roles of all stakeholders.
The report, by auditing and finance firm Grant Thornton, argues that regulatory challenges, clinical trials and efficacy tests continue to present a "huge investment outlay." Over the next four years, the report found, branded biologics representing $40 billion in sales will come off patent, not to mention the $20 billion worth of products already off patent.
The Generic Pharmaceutical Association, a trade group representing generic drug makers, said the report "underscores the need for swift and decisive action to make the promise of biosimilar medicines a reality for the millions of American patients in need of lifesaving biologic treatments."
"Even with the most conservative estimates, this report shows that biosimilars hold the potential to save $20 billion annually," GPhA president and CEO Ralph Neas said.