Want Generic Biotech? You Might Wait 14 More Years
Late last night, a pair of congressmen introduced a bill aimed at creating a pathway for approval of generic biotech drugs.
Finally, you say. But, wait, there’s a catch, and it’s a big one. The legislation would also give brand-name biotech drugs an extra 14 1/2 years of patent protection. (Read a summary of the bill, or the complete text.) That almost defeats the purpose of establishing a route to market for generic biotech drugs, advocates for them say.
Not surprisingly, the Biotech Industry Organization (BIO) is delighted with the bill, which the group says “includes essential elements to ensure that any such pathway follows two critical principles: namely, protecting patient safety and ensuring continued innovation.”
The Generic Pharmaceutical Association is livid. Under the provisions of the bill, “it will be decades before patients have access to affordable biogeneric medicines,” the group said in a statement. “For the countless patients who are choosing between paying for their medicines and putting food on their tables, waiting decades is simply not an option.”
For the past several years, biotech companies and generic drug makers have been engaged in a tug of war over the issue of copycat versions of biotech drugs, known […]
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