Follow-on biologics 'not substitutable', says BIO

The paper called "The difference with biologics: the scientific, legal and regulatory challenges of any follow-on biologics scheme" highlights the impact of the differences between biologics and traditional small molecule drugs on legislation. According to the paper, biologics have very different physical structure and characteristics from drugs that are based on small molecules which makes it impossible for follow-on versions of biopharmaceuticals to be duplicates of their original version - they can only be comparable or similar, the BIO said. The industry body argues that the approval pathway in place for standard generics - supported by the Hatch-Waxman Act - cannot be applied to biologic drugs. "The scientific, legal and regulatory issues involved in creating any approval pathway for follow-on biologics are complicated,"​ stated Jim Greenwood, president and CEO of BIO. The prickly debate between the biotech and generic industries regarding whether so-called biosimilars can really be considered generics has been going on for months and the US Congress is now about to take a decision on how to implement a law that would enable companies bring those follow-on versions (dubbed biosimilars by the European regulator) to market. Big biotech firms argue that their biopharmaceuticals cannot be reproduced exactly while biogeneric companies unsurprisingly say they are able to duplicate them. Another argument highlighted by the generic camp is the actual savings that would potentially be made, should such biosimilars be introduced. Indeed, there is a growing concern surrounding the steep cost of developing and manufacturing new biologics. Biotech drugs that treat diseases such as cancer and multiple sclerosis cost tens of thousands of dollars per patient. And a report published last week found that biologic drugs are expected to account for over a quarter of overall drug spending in the US by 2010, and suggested that clearing the path for generic versions of these drugs could be a solution to controlling rising national healthcare costs. Data showed that spending on biotech drugs climbed 21 per cent in 2006, compared with 6 per cent growth for traditional chemical-based pharmaceuticals The report released by pharmacy benefit manager Express Scripts estimates that overall biotech drug costs will account for 26 per cent of total drug spending and will reach $99bn (€73bn) in five years, almost twice the $54bn spent on these so-called specialty drugs in 2006. With the average cost of a biotech drug up to 20 times higher than the average cost of a traditional drug, generic versions of biotech drugs are seen by many as a potential tool in the future for managing costs. However, new research published this week by a North Carolina university suggests that generic versions of biologics would not be significantly cheaper than their brand-name versions. "Congress and the FDA are currently addressing this issue and developing a process for the oversight of generic biologics, partially in hopes of generating significant cost savings for consumers and insurers,"​ said Kevin Schulman, director of Duke University's Health Sector Management programme. "However, our research indicates that any savings to be expected from the addition of generic biologics to the marketplace will be significantly less than the savings generally available from generic pharmaceuticals." ​ The research team, which also included David Ridley, a professor in Duke's Fuqua School of Business, combined a theorical model of generic biologics with historical data from the generic pharmaceutical market, in a bid to predict prices of 'biogenerics". However, it is important to note that the research was funded by the world's second biggest biotech company, Genentech. "We urge Congress to give these issues the thoughtful deliberation they require without unnecessarily rushing the debate and putting patient safety and biomedical innovation at risk,"​ said Greenwood.