FDA maps out long-awaited rules for the biosimilars business

The FDA has finally issued its eagerly anticipated draft of rules governing the development of biosimilars, laying out a roadmap for a multibillion-dollar industry that's been rapidly taking shape under the wing of big biopharma companies and a slate of multinational players.

Analysts quickly concluded that the rules largely fit a broad framework that FDA officials have been outlining for months now. Regulators will typically require developers to provide clean animal data on toxicity and compelling PK and PD data from human studies. Additional studies may be required before a developer can win approval for an "interchangeable" therapy, which would allow payers and pharmacists to automatically switch a patient to a less expensive copy.

The rules "reads largely as we expected, although a few points read as slightly more friendly to the generics industry," ISI Group analyst Mark Schoenebaum noted, according to Reuters.

The FDA, though, was very careful to detail a high standard for biosimilars. Faced with the challenge of evaluating copies of complex biologics, which can be altered simply by changing manufacturers, regulators made it clear that these new drugs will typically require expensive late-stage human studies. The science behind the target will be understood, and the discovery and early-stage work largely unnecessary, but they left an exacting hurdle for developers to clear. And each program will have to be tailored to fit the FDA's requirements.

"Instead of starting from scratch, these companies will be starting in the middle of the process," said Rachel Sherman, FDA associate director for medical policy, according to The Wall Street Journal's article. "We're trying to send the signal that it's not one-size-fits-all. It's product-by-product."

The biosimilar industry taking shape, then, is likely to offer new products which are, at least initially, not interchangeable. Due to the heavy cost of development, these new biosimilars will be offered at a discount of around 10% to 20%, but without the drastic markdowns that obliterate a small molecule's retail value in months. And that will be welcome news inside many biopharma companies, which can now look forward to managing more limited competition after a long period of exclusivity on the market.

- here's a copy of the rules
- see the Reuters report
- read the Bloomberg story
- get the article from The Wall Street Journal