US turns up pressure on biotech drug exclusivity

In a further sign of US plans to cut the size of the country’s drug bill (see page 6), driving down health care costs, the White House has released a letter stating that biotechnology drugs, or biologics, should only receive seven years of data exclusivity. Biologics are amongst the most expensive drugs and opening the market to generic competition could save millions of dollars. The American Society of Clinical Oncology estimates that a course of a monoclonal antibody, like Genentech’s breast cancer drug Herceptin (trastuzumab), can cost as much as $65,000.

No framework exists yet for the approval of generic biologics – biosimilars – in the US, but proposals were put forward in the budget. Some concerns remain over biosimilars as they are complex proteins and, unlike small molecule generics, the production process could lead to minor changes, which could alter their action ( C&I 2008, 24, 14).

The conclusions in the letter are based on a report by the Federal Trade Commission (FTC), saying it ‘directly assessed the arguments that the pharmaceutical industry has made regarding their need for 12-14 years of exclusivity; the FTC rejected those arguments’. They argue that lengthy protection periods would delay access to affordable drugs and damage innovation.

‘Given the current overhaul of the US health care system, with reducing costs a key feature, shorter branded exclusivity is almost a certainty,’ says Pam Narang, a pharmaceutical industry analyst at Datamonitor. ‘Branded biologics will benefit in the short term from initial resistance to biosimilar uptake due to their novelty and safety/efficacy concerns,’ she adds. Companies with brand name drugs will also have another advantage for diseases like diabetes, where service provision and training are important.

Jim Greenwood, ceo of the Biotechnology Industry Organization, said: ‘Any pathway to biosimilars should provide a fair period of time for innovators to protect their proprietary data from competitors.’ He also reiterates the industry’s call for 14 years of data exclusivity.