BIOGENERICOS: Rectificar es de...12 años

Casi ya estaba aprobado que serian 7 años la protección de que gozaria su patente. Ahora las cosas retroceden al gusto de las empresas investigadoras y disgusto de las compañías de genéricos.

House Energy and Commerce Committee ranking member Joe Barton (R-Texas) and Rep. Jay Inslee (D-Wash.) on Tuesday introduced legislation that would allow FDA to approve generic versions of biologic drugs, CongressDaily reports. The bill would give brand-name biologic drugmakers a 12-year period of exclusivity for their products before generic competition can be introduced. The measure also would require data from generic companies.

The legislation competes with a bill (HR 1427) introduced last week by Energy and Commerce Committee Chair Henry Waxman (D-Calif.) and Health Subcommittee ranking member Nathan Deal (R-Ga.) that would give brand-name companies five years of exclusivity and provide FDA with more flexibility in determining data required for generic approval (CongressDaily, 3/18).

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