When Will Biogenerics Be Available?

When biotech drugs cost tens of thousands of dollars a year, it is no surprise that so much pressure is mounting to make biogeneric drugs available. Generic versions of biotech drugs could provide major cost savings for consumers and for society in general. In the drive to make drugs more affordable, however, it is vital that patient safety is not compromised.

As the use of biotech drugs has expanded, so have the potential savings that biogenerics could deliver. Sales of biotech drugs have surged past $50 billion, confirming this sector as one of the fastest growing and most profitable in the pharmaceutical industry. If biogener-ics can deliver even a fraction of the price reductions that we have seen with generic versions of small-molecule drugs, they could offer much-needed relief to millions of people suffering from cancers, arthritis, and other conditions.

The issue remains complex and problematic, however. The FDA has sometimes seemed unable to take action. It stalled for years before approving the first biogeneric, making a decision only when directed to do so by the courts.

The establishment of regulatory pathways is only the first step. Most agree that biogenerics makers will typically have to provide additional data to show safety and efficacy comparable to those of the branded version of the drug. It often may mean more clinical testing, requiring more time and expense to bring drugs to market. In turn, this will result in higher prices for biogenerics. Physicians cite safety and efficacy as their top concerns, according to a report by research firm Decision Resources.

The approval process may become less difficult over time, FDA officials suggested in a recent paper in Nature. They said that the evaluation of biogenerics will be an evolving process, as advances in characterization and manufacturing ?reduce some of the complexity and uncertainty inherent in the manufacturing of protein products.?

Clearly, safety is critical. The pharmaceutical industry is still reeling from recent safety problems with brand name drugs. If similar problems emerge with biogenerics, it will not only cause tragic consequences for patients; it also could undermine patient and physician confidence in biogenerics in general, threatening the viability of this emerging industry. Patience will be needed to establish a firm definition of the safety data required for each class of drug.

We applaud those who have worked so hard to create solutions in this perplexing area. We urge legislators, agencies, and the industry to continue to work together to bring biogenerics to patients as quickly as possible?but not at the cost of patient safety.

Mr. Eckel is professor and director of the Office of Practice Development and Education at the School of Pharmacy, University of North Carolina at Chapel Hill.