An approval process for biogeneric drugs could be formalized as soon as next year--though many issues, ranging from scientific standard to price setting, remain to be settled.
With $10 billion in biotech revenue coming up for grabs over the next five years, the generics industry has already started to make some investments in follow-on biologics, mainly in Europe, where a regulatory process is already in place. If given the green light, these companies will have a ready chest of studies to present to FDA for approval.
In her testimony last month in front of the House Oversight Committee, Janet Woodcock, FDA deputy commissioner and chief medical officer, noted that the agency is already willing to review applications for follow-on proteins on a case-by-case basis.
Generics firm Hospira is a member of the Coalition for a Competitive Pharmaceutical Market, an advocacy group on generic drug policy. The company is currently testing biosimilar erythropoietin in Germany, where it hopes to establish the artificial hormone treatment for anemia before cracking the US market. "We believe this will be a great business opportunity for us," said Thomas Moore, president of global pharmaceuticals at Hospira, the largest producer of generic injectables. "This is a space that meets our corporate mission and provides health-economic benefits."
Rep. Henry Waxman (D-CA) has introduced a biogenerics bill called Access to Life-Saving Medicine Act, cosponsored in the Senate by New York Democrats Hillary Clinton and Charles Schumer--and Jim Li, a former FDA biotech reviewer, believes that Congress may pass an approval process within the next year or two.
Yet regulators still have a long list of concerns--including how manufacturing changes will affect a product's quality, identity, and capacity to trigger immune responses. Because biologics are made from living cells, testing a biogeneric's equivalency to the branded product is more complex--and costly--than the chemical-identity proofs for small-molecule drugs.
Generics companies will have to conduct studies showing that their compound is not only safe and effective but comparable to--if not interchangeable with--the brand-name biologic. "FDA has the flexibility on a product-by-product basis to see what studies are needed," said Li, currently the associate director of global regulatory affairs at Wyeth. "No matter which side you're on, you can see how one size can't fit all."
Given these hurdles, it remains to be seen how much money consumers will actually save. "While you will see price erosion and price savings, it could be a different situation than small molecules," Moore said. "It's one of those things that's going to be determined by the pathway."
Generics companies might also need to build their first sales force, since follow-on biologics are unlikely to have the same "substitutability" at the pharmacy that small molecules enjoy. In other words, for a patient to receive a biogeneric, a doctor would have to expressly prescribe it. "It's been very difficult to predict that price side of the business," Moore said. "Our expectation is that we're going to have a sales organization that is creating demand."