Kennedy Opposes Easy Entry for Generic Biologics

In a huge blow to everyone concerned about skyrocketing health care costs, Sen. Ted Kennedy (D-MA) is promoting legislation that will make it extremely difficult for generic biologics to enter the market.

According to this morning's Boston Globe, Kennedy's bill would require a follow-on biologic (like a generic for Amgen's Epogen, now in its 20th year of patent exclusivity) to conduct all the same efficacy trials as the original drug. The Senate Health Education Labor and Pensions Committee will hold a hearing Thursday.

Rep. Henry Waxman (D-CA) has introduced legislation that would speed the introduction of generic biologics, but he has run into stiff opposition from the Biotechnology Industry Organization, now headed by former Congressman James Greenwood. BIO has Kennedy's ear. Why? Massachusetts is home to numerous biotechnology companies, including Genzyme, which has lobbied hard against Waxman's bill. Genzyme's patent on Cerezyme, the recombinant protein for Gaucher's disease and, unless I'm mistaken, still the most expensive drug in the world, has another decade to run.

Kennedy and the biotech industry say every protein line is distinct, and each one must be tested for safety and efficacy before being allowed on the market. Firms that want to produce copycat versions of biologics say that traditional testing for similarities in chemical composition should be sufficient, as it is in the rest of the drug world. Requiring efficacy tests will make every product, even if a generic with regard to patent law, distinct, and make follow-on biologics more like me-too drugs than true generics, which are usually half the cost of the original molecule. Me-too drugs usually enter the market at a small discount to first-to-market drugs.