White paper on exclusivity period for biotech drugs prompts criticism

ARLINGTON, Va. A white paper by the Biotechnology Industry Organization that argues for a 17-year market exclusivity period for biotech drugs has prompted criticism from an organization representing the generic drug industry.

The Generic Pharmaceutical Association, which has pushed heavily for a regulatory pathway for biosimilars, copycat versions of biotech drugs, criticized BIO's white paper as attempting to create a barrier to competition.

"BIO's white paper represents more of the same, as they seek to erect barriers to competition and keep affordable biogeneric medicines out of the hands of consumers," GPhA president and CEO Kathleen Jaeger said in a statement, using GPhA's preferred term for biosimilars. "Numerous reports have shown that biogeneric competition will create tens if not hundreds of billions of dollars in savings for consumers and the government within the first 10 years."

BIO has mostly pushed for a 14-year exclusivity period to allow biotech companies to recoup expenses from innovation before they face competition, though the FDA allows five years of exclusivity for pharmaceutical drugs before they become open to generic competition under the provisions of the Hatch-Waxman Act. GPhA favors a similar model for biologics.

BIO has said it favors a regulatory pathway to allow biosimilars, but insofar as it emphasizes patient safety over savings. Government organizations, BIO and drug makers tend to use the terms "biosimilars" and "follow-on biologics" rather than "biogenerics" because they say the complexity of biologic molecules and manufacturing processes make it possible to create similar molecules, but impossible to create identical molecules, as in the case of generic pharmaceutical drugs. BIO and the FDA have expressed concern that a biosimilar could affect a patient's body differently from its branded counterpart.