Biogenerics Advancing

The Washington Post editorializes this morning in favor of a biogenerics bill that will make easier for consumers to buy discounted versions of the priciest drugs now on the market once their patents expire. That's good news. The Post editorial page is an important bellwether of the inside the Beltway consensus, and the fact it addressed the topic now suggests some key compromises may have been reached on the bill moving through the Senate Health Committee.

Biologic drugs like erythropoietin or human growth hormone are genetically engineered versions of complex proteins, and the processes needed to produce them with guaranteed purity and consistency is equally complex. But it isn't beyond the capacity of any well-trained biochemistry team working in labs equipped with the latest fermenters, filtering and fractionating columns, which are readily available on the commercial market. As deputy FDA commissioner Janet Woodcock recently testified, the FDA routinely monitors biologics production lines for good manufacturing practices and to ensure that what goes into every vial is the same. There's no reason why it couldn't apply the same standards to a generic manufacturer.

The crucial question is whether the law will require generic firms to conduct a full range of clinical trials for its first production batches of follow-on biogenerics, rather than just a limited trial to ensure that the generic manufacturers' cell lines produce the same biological effect once injected into humans. If the law requires a full efficacy trial, it will restrict the number of companies willing to make the investment, and make the price of the follow-on drug more like the innovator's price, not the 40-50 percent discount typical of generics. In other words, biogenerics will be more like me-too drugs than true generics.

The Post editorial gets this crucial question right. It said:

"The FDA should be given greater latitude to design approval requirements on a case-by-case basis, which almost certainly would include clinical trials of various sizes. This is a flexible approach that would ensure speedy approval when possible and that could adjust to changing science."

The science will only make it easier over time to make and approve follow-on biologics. Requiring full-fledged efficacy trials for every biogeneric would put the FDA in a straightjacket tailored by the biggest players in the biotechnology industry, Amgen, Genentech and Genzyme, whose only goal is to protect their patent monopolies.