Washington Report: Pathways for Proteins

Innovators want exclusivity and clinical studies for follow-on biologics, but visions of billion-dollar savings may short-circuit the scientific debate
May 01, 2007

Jill Wechsler
The push is on to establish an approval pathway for generic versions of biotech therapies. The Hatch-Waxman Act of 1984 established a process whereby generic-drug manufacturers could obtain approval for a product based on the innovator company's data. But Hatch-Waxman doesn't apply to biologics regulated by the Public Health Service Act, and generics makers—as well as some Big Pharma companies and small biotech firms—want Congress to give the Food and Drug Administration authority to set up a similar process for these products as well.

As momentum builds for legalizing follow-on proteins (FDA's preferred term), pharma wants to keep the issue from blocking speedy reauthorization of the Prescription Drug User Fee program. Billy Tauzin, president of PhRMA (Pharmaceutical Research and Manufacturers of America), said at a recent press briefing that "there will be and there should be" follow-ons, but that the legislation should be "done correctly" and not become "a political football."

Cutting Costs

Payers, pharmacy benefit managers (PBMs), and patient advocates see follow-ons as a way to ratchet down the cost of increasingly expensive therapies. Life-saving drugs are not worth much, they argue, if patients can't afford them. Express Scripts, a PBM, unveiled a report in February projecting savings of some $70 billion over 10 years from biogenerics. Another study put the savings at $14 billion for Medicare alone.

Similar, or Equivalent?
On the other hand, consulting firm Avalere Health estimates savings of only $3.6 billion over 10 years. The firm's analysts say it will take years for follow-ons to be developed and approved, and that these products will cost more to test and produce than conventional drugs. Moreover, if follow-ons are not interchangeable with innovator products, physicians will be slow to prescribe them.

Well-known health economist Henry Grabowski of Duke University explained at a hearing before the House Oversight and Government Reform Committee in March that the fairly high cost of developing follow-ons will limit market competition, resulting in discounts of 10 to 25 percent—not the 60-percent price cuts seen in the highly competitive generic-drug market. But payers say that prices even 10 percent lower will save millions on products that in some cases cost more than $100,000. The United States spends more than $3 billion a year on insulin, and state Medicaid agencies are scratching for any savings they can find.

Seeking Exclusivity

Given the political pressures to legalize follow-ons, brand-name firms are focusing on patent protection. The Hatch-Waxman Act provides five years of exclusivity before generics can challenge a new drug's patent. In Europe, drugs and biologics essentially are protected for 11 years—and that looks good to US innovators, especially small biotech companies. The high cost of developing new biologics—which the Tufts Center puts at $1.25 billion fully capitalized—and of manufacturing them warrants stronger patent protection, the industry claims.

The lead biogeneric bill, sponsored by Rep. Henry Waxman (D-CA) and backed by Sen. Hillary Clinton (D-NY), doesn't address exclusivity. But generic-industry leaders appear willing to negotiate the issue in order to move legislation forward.

Stress on Science

The ultimate cost of follow-ons will depend largely on how much pre-clinical and clinical testing sponsors have to conduct to gain FDA approval. Innovators insist that some clinical testing is necessary and that even then follow-ons won't be equivalent to brands. Everyone says that science should determine the scope of follow-on testing, but there's disagreement over where the science stands. The key questions:

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