Originally published in CQ HEALTHBEAT NEWS on Jan. 9, 2015 – 5:02 a.m.

Path to First U.S. Generic Biotech Drug Still Lined With Uncertainty

By Georgina Gustin, CQ Roll Call

A panel of Food and Drug Administration advisers gave a green light to a generic biotech drug this week, agreeing unanimously that the product was “highly similar” to the original and clearing a path for it to become the first of its kind on the U.S. market.

But challenges and questions still loom, and the expected price breaks usually associated with copycat medicines could be further off than some would hope.

The Food and Drug Administration is reviewing an application by Novartis AG’s Sandoz unit to market a version of Neupogen, a drug made by Amgen Inc. to boost infection-fighting white blood cells during chemotherapy.

Neupogen, with sales of $1.4 billion in 2013, is among a class of complex – and costly – drugs known as biologics. While traditional drugs typically contain one synthesizable chemical molecule, biologics are made from human or animal tissues, usually via biotechnology. The industry has long argued that the products are so complicated they can’t be replicated, and has tried to block any regulatory or legislative efforts that would speed approval, effectively protecting its lock on the market in the process.

But the FDA is now reviewing Sandoz’ bid, as well as at least two other “biosimilar” products using an abbreviated process mandated by the 2010 health care law (PL 111-148, PL 111-152). Its task, according to the law, is to determine whether the drugs are “highly similar” to the original or have any clinically meaningful differences.

Beyond that, the FDA also has to determine what it will allow the new product to be named. The FDA, in approving a drug, sanctions a generic name as well as a trade name. When a drug goes off-patent, generic drugmakers can choose to market their products under their own, new trade name or the generic name. The generic name for Neupogen is filgrastim. The drug is currently sold in Europe and other highly regulated markets under that name.

But some consumer and patient advocacy groups are asking the FDA to give the copycat version a name that distinguishes it from the original. They note that, while a copycat might be highly similar and have no significant clinical differences, slight changes in manufacturing processes or inactive content might have adverse effects.

At this week’s meeting of the FDA’s Oncologic Drug Advisory Committee, several people appealed to the panel to urge FDA to consider a distinguishing name.

“We need to be absolutely clear about the medications I’m taking, and I have the right to make truly informed choices about those medications,” said Donna Cryer, who runs an healthcare consultancy group, is the former head of the Global Liver Institute and a liver transplant patient. “Allowing branded biologics and biosimilars to have the same name violates these principles.”

Deborah Armstrong , the panel’s chair, said however, that “naming is not something that the committee has anything to do with,” leaving the decision to the FDA. The agency has said it’s currently considering the appropriate naming convention, but has not commented beyond that.

The generics industry, meanwhile, has urged the agency to keep the same name. “Importantly, a departure from the currently accepted international nonproprietary naming system could disrupt experts’ ability to track and dispense these medicines, risking provider confusion and elevating the likelihood for mistakes,” said Ralph Neas, head of the Generic Pharmaceutical Association, or GPhA.

The generics industry is also awaiting guidance from the FDA on interchangeability, or the ability to substitute a brand name, or “reference” drug, for a generic. While the pending Sandoz application requests approval on a “non-interchangeable” product, the agency’s guidance will nonetheless steer the fate of future biosimilars.

“This is a positive step toward increasing competition and in turn lowering prescription drug costs for consumers, employers, government programs and others,” said Mark Merritt, chief executive for the Pharmaceutical Care Management Association, in a statement. “To encourage use of biosimilars, the FDA should act to allow interchangeable biosimilars to be substitutable for their reference products.”

It’s also unclear how much of a cost savings the product could represent, though lowered prices in Europe and other markets portend a break on cost. “We can’t say that the price will be less because in some situations the price will be at parity.” said Mark McCamish, head of oncology injectables at Sandoz.

“Price is not as easy as one would expect, and we can’t just say the price is going to be X. But we moved from seven in the marketplace to competing with two or three because the cost of using our product is lower.”

Typically, the FDA renders it decision four to six weeks after an advisory panel makes it recommendations. But it’s unclear how long it will take in this case.

Georgina Gustin can be reached at ggustin@cq.com.

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