Generic biologics to hit US market

Biologic drugs are produced from living cell cultures rather than synthesized chemically, and the market for these medicines currently growing at an impressive annual rate of 20 per cent. They are also among most expensive items on the nation's drug bill, costing patients anything from $10,000 to $200,000 a year.

The new bill will give the FDA the express legal authority to approve the generic biotech drugs, and the ability to decide on a case-by-case basis what additional clinical information is required before approval will be granted.

The "Access to Life-Saving Medicine Act"​ means the FDA will be able to approve abbreviated applications for biological products that are 'comparable' to brand name biological products that have already been approved, which is set to challenge the monopoly prices biotech drug manufacturers can currently charge for their products.

"Biologics treat some of the most devastating diseases around and no one should be denied access to them because they're too expensive,"​ commented Senator Charles Schumer, who supported the introduction of the bill.

"Generic biologics can be a safe and affordable alternative to high-priced brand name biologics. Our legislation will…[enable] competition in the market to lower the price and [end] permanent monopolies over biologic products."​

The FDA has been able to approve generic versions of traditionally produced drugs since 1984, but biological-based drugs cannot be produced generically under current law in the US. The new bill would address this imbalance, and also remove the need for repetition of expensive and duplicative clinical trials in many cases.

The bill states that the candidate 'comparable' biologic must have "principal molecular structural features"​ that are highly similar to those of the existing brand name product, and must have the same mechanism of action, if known.

In a bid to encourage the development of 'interchangeable' products (those than could be substituted for the branded product at the pharmacy level), the legislation provides the first applicant to obtain approval of an interchangeable product an exclusivity period, during which no other interchangeable versions of the product may be approved.

The FDA has approved over 250 biotech medicines so far, with 39 biologic products and indications approved in 2005 alone. Over 400 biologic products are in various stages of development in this ever growing field, targeting over 100 diseases from multiple sclerosis, diabetes and AIDS to arthritis, heart disease and Alzheimer's.

In 1992, annual revenues for the biotech industry hit around $8bn, by 2003 this had jumped to $39bn, and by 2009 sales of biologics are predicted to reach $90bn.

Many biologics have already come off patent, with no generic alternatives able to take advantage of the fact. However, with the implementation of the new legislation generics manufacturers will be able to benefit from the $10bn dollars' worth of biopharmaceutical drugs that are due to come off patent by 2010.

Generic versions of traditional, chemically synthesized drugs offer much cheaper alternatives to branded products also available. Generic versions of these traditional drugs represent 56 per cent of total prescriptions in the US, but only 13 per cent of spending on prescription drugs.

If generic biologics can offer comparable savings, vast sums of money could be saved on treatment costs, with estimates of savings for the Medicare inpatient pharmaceutical program hitting $14bn over 10 years.