Want Generic Biotech? You Might Wait 14 More Years
Posted by Heather Won Tesoriero
March 14, 2008, 4:38 pm
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.)
eshoo.house.gov
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 variously as biogenerics, biosimilars or follow-on biologics. Unlike pills and syrups, which are relatively simple to copy, biologics are derived from living cells and are trickier to manufacture. Almost everyone seems to agree that a smoother regulatory pathway is needed to make available cheaper yet safe equivalents to brand-name biotech blockbuster. But the details are almost as hard to come by as a good line of Chinese hamster ovary cells, workhorses of biotech drug manufacturing.
The latest House bill was introduced by Reps. Anna Eshoo (D-Calif.) and Joe Barton (R-Tx.). Besides extending patent protection for branded drugs, the bill would require generics manufacturers to get guidance from FDA on manufacturing and testing before applying to make a biotech drug. A Senate bill on biogenerics passed through the Health, Education, Labor and Pensions Committee last June.
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