Biologics: The next generation

September 1, 2007

Regardless of the fate of a committee-approved Senate bill outlining a regulatory pathway for approval of follow-on biologics, sources agree that it's just a matter of time before such drugs become reality.

National report - Congress is considering establishing a regulatory pathway for federal approval of follow-on biologic drugs. But whatever the current legislative outcome, sources agree that it's just a matter of time before such drugs become a reality.

"There is no longer a debate about the science. ... The science exists to produce these medicines," says Andrea Hofelich, spokeswoman for the Generic Pharmaceutical Association (GPhA), a generic manufacturers' trade association.

In late June, the Senate Committee on Health, Education, Labor and Pensions approved a bill to create the Biologics Price Competition and Innovation Act, sponsored by Sen. Edward Kennedy (D-Mass.). The bill provides 12 years' marketing exclusivity for name-brand innovators.

The congressional interest is generating debate among dermatologists, manufacturers and industry groups regarding the safety and quality of biosimilar products, as well as their potential impact on the doctor-patient relationship and the incentive for pharmaceutical innovation.

"It's possible under (Sen. Kennedy's) bill for a biosimilar to end up on the market with no data establishing its safety," says Sandra Dennis, deputy general counsel for healthcare regulatory affairs, Biotech Industry Organization (BIO), a biologic manufacturer's trade group.

The bill also has sparked controversy about the appropriate period of marketing exclusivity, as well as the following elements:

Dermatologist Alan Menter, M.D., of Dallas says he favors lowering the cost of medicines and making drugs less cost-prohibitive, both for patients and for insurance companies.

However, he says, "The big question always has to be the viability of (innovator) biologics and the patent rights companies enjoy for the research, time and expertise they put into developing the drug. Biologic drugs are a great deal more expensive to manufacture" than traditional systemic drugs, says Dr. Menter, who is chairman, division of dermatology, Baylor University Medical Center, Houston.

But Noah Scheinfeld, M.D., contends, "The bottom line is that $16,000 a year for a medication is far more than the cost of manufacture."

Still, he says, "We don't have enough experience in other cases of biologics and generics to see where the price point is going to come out." He is assistant clinical professor of dermatology at Columbia University, New York.

Safety concerns

Some physicians raise safety questions.

If biosimilars and their predecessors are at all different, "The efficacy and safety might be dramatically different," says Mark Lebwohl, M.D., professor and chairman, department of dermatology, Mount Sinai School of Medicine, New York.

BIO spokeswoman Ms. Dennis says, "It's most important that the physician be involved" in any decision to substitute one drug for another, given that a follow-on version is not exactly the same as the original drug. "Bills we support wouldn't allow substitution without doctor involvement."