Obama backs 7-year exclusivity for biologics

The Obama administration is throwing its weight behind a shorter exclusivity period for biologics. These products should be open to generic competition after seven years, the administration said, rather than the 12 to 14 years [1] branded drugmakers have lobbied for, Bloomberg reports. That's a "generous compromise" upward from the five years proposed by at least one Congressional leader.

"Lengthy periods of exclusivity will harm patients by diminishing innovation and unnecessarily delaying access to affordable drugs," Nancy-Ann DeParle, director of the Office of Health Reform, and Peter Orszag, director of the Office of Management and Budget, wrote to Rep. Henry Waxman, who is working on legislation that would allow the copycat biologic meds.

As you know, current law doesn't allow copycat forms of biologic meds, even after their patents have expired. There's long been a movement to open up a so-called "regulatory pathway" for biosimilar meds, but those efforts have gained real traction recently as legislators hunt for any and every way to save money on healthcare. Branded drugmakers, generics firms, insurance plans, politicians and plenty of others have opinions about just how generic biologics should work. The debate has only just begun.

- read the Bloomberg story [2]

ALSO: Japanese regulators approved a human growth hormone from Novartis, the first green light in Japan for a biosimilar or generic version of a biotech drug, the Swiss drugmaker said. Report [3]

Related Articles:
FDA talks biogenerics at DIA 2009
FTC: 12-14 years too much protection for biologics [4]
Biosimilar bill offers 12 years of market exclusivity [1]
Lawmakers propose biogeneric bill [5]
Obama to back biogenerics [6]