US campaigners yesterday urged Congress to create a “real” regulatory pathway for generic versions of biologic drugs, but researchers warn that it may take until 2011 to implement any such policies.

Current proposals for a regulatory pathway for generic biologics - also known as biosimilars, biogenerics or follow-on biologics - in Senate and House healthcare reform bills will actually block production of most generic biologics, but if these are improved in critical ways they could save $71 billion or more in the first decade alone, say the consumer and medical student groups which are leading the campaign.

The proposals, originating from Representative Anna Eshoo House bill HS 1548 and past bills in the Senate, would provide 12 years’ market exclusivity for biosimilars compared to five years for other drugs. However, the campaigners point out, the Pharmaceutical Research and Manufacturers of America (PhRMA) puts development costs for biologics at $1.2 billion, close to that for conventional drugs at $1.318 billion, and that the Federal Trade Commission (FTC) recommends zero years market or data exclusivity for biologics, given that biosimilars will cost more to bring to market for generic manufacturers than conventional generics, leaving originator companies with 70%-90% of the market.

These proposals will also allow “evergreening,” whereby pharmaceutical companies will be allowed additional 12-year periods of exclusivity for “relatively inexpensive minor tweaks” which, they say, could block price-lowering generic competition indefinitely.

The language in these bills creates biologic drug monopolies, which discourage innovation and raise costs for the US health system, say the campaigners. However, they add that these problems can be addressed by adopted the relevant sections of bills introduced by Representative Henry Waxman (HR 1427) and Senator Charles Schumer (S 726), which would allow five years’ exclusivity and block evergreening.

Biologics are the fastest-growing segment of the drug market, are predicted to be 50% of new drug approvals soon and include most vaccines and treatments for cancer, multiple sclerosis and rheumatoid arthritis. Already, the top six biologics make up over 40% of expenditures for the Medicare prescription drug programme, the campaigners add.

Meantime, researchers in the current issue of the British Medical Journal (BMJ, September 19, vol 339) warn that “unless biological therapies can be made more affordable, western health care systems face a financial crisis.”

Demand for biologic therapies is enormous, clinicians are prescribing them at increasing rates and pressure is growing to use them earlier in disease progression, say the authors, consultant physician Fraz Mir and student Christopher Kelly of Addenbrooke’s Hospital in Cambridge, UK. However, they add that potential generic manufacturers face a number of major hurdles, not least the fact that development of a biosimilar costs about £120 million compared to £1-£2.5 million for a small-molecule generic. Moreover, while US President Barack Obama’s first budget in February included proposals for an abbreviated regulatory pathway for biosimilars, it may take until 2011 for the Food and Drug Administration (FDA) to implement any new policies, they suggest.

- The global market for biosimilars is expected to be worth US$19.4 billion by 2014, increasing at an average annual rate of 89.1% from 2009, according to a new report from Marketsandmarkets,