PHARMACY

White paper on exclusivity period for biotech drugs prompts criticism

BY Alaric DeArment

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.

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FDA approves generic version of Depakote

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a generic version of Abbott’s Depakote, FDA records show.

The agency approved Dr. Reddy’s Labs divalproex sodium delayed-release capsules in the 125 mg strength. The capsules are used to treat epilepsy, bipolar disorder and migraine headaches.

The branded version of the drug had sales of $1.5 billion in 2007, according to Abbott financial records.

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FDA approves Mylan’s generic epilepsy drug

BY Alaric DeArment

PITTSBURGH The Food and Drug Administration has approved Mylan’s generic version of GlaxoSmithKline’s epilepsy drug Lamictal, Mylan announced Wednesday.

The drug, known generically as lamotrigine, is also used to treat bipolar disorder. Mylan will sell the drug in the 25 mg, 100 mg, 150 mg and 200 mg strengths. The FDA also approved Genpharm?s application for a chewable generic version of Lamictal.

The branded version of the drug had sales of about $91 million in the year ending Sept. 30, according to IMS Health. 

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