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Ensuring Effective U.S. Biogenerics Legislation: Avoid Inappropriate Marketing Monopolies (Data Exclusivity)
Providing timely access to affordable, safe and effective products should be the central purpose of U.S. legislation that introduces a regulatory pathway for the approval of generic substitutes for biologic pharmaceuticals (also known as “biotech drugs”). Provisions that extend the monopoly protection period of brand-name companies, making it unreasonably difficult to sell affordable biogenerics to patients as soon as possible after patent expiration, would defeat the purpose of the new rules.
What is Data Exclusivity?
When a generic company seeks approval from the Food and Drug Administration (FDA) for a generic drug, it shows that its product is the same as, or essentially similar to, a brand-name product. It then relies on, but does not repeat, the clinical tests performed by the brand-name maker. Data exclusivity prohibits the generic firm from relying on the brand-name test data, effectively barring the generic competitor from the market for a set period of time and extending the monopoly period. Data exclusivity can delay the introduction of generic competition — keeping prices high longer — for drugs that are not able to obtain patent protection, or for which the patent term has expired.
The Legislative Landscape and Data Exclusivity
All but one of the legislative proposals introduced by Congress to amend the Public Health Services Act (PHSA) over the past two years call for significant and unprecedented periods of data exclusivity prior to marketing approval of biogenerics (for periods ranging between 8 to 15 years, plus extensions in some cases). Essential Action believes that data exclusivity provisions should not be included in U.S. biogenerics legislation.
Click here to download a .pdf version of a fact sheet on this topic: Biogenerics_and_Data_Exclusivity.pdf
Click here to download a .doc version of a fact sheet on this topic: Biogenerics_and_Data_Exclusivity.doc