Biosimilars take a big step toward the marketplace

FDA's draft documents on biosimilar regulation move the prospect one step closer


 

On Feb. 9, FDA released a batch of some of the most important documents in recent memory: how it plans to regulate biosimilars. The three documents—which will have been examined an criticized in detail by the time you read this editorial—represent years of industry and agency deliberation, which started years before the Patient Protection and Access to Care Act of 2010 (PPACA), the Obama Administration's much-maligned law to open up access to healthcare. And since it took two more years inside FDA to generate merely the draft guidance, we can expect more debate in the months to come. Whether February 9, 2012 will be the red-letter date that people refer to in the future as the beginning of the biosimilar era, or whether it just becomes a footnote to later announcements, remains very much to be seen.

One thing we can all stop talking about, though, are all the concepts floating around the biosimilar topic—"biogenerics," "biobetters" and the like. The one message that comes through most clearly on a summary reading of the documents is the stance that "FDA intends to consider the totality of the evidence provided by the sponsor to support a demonstration of biosimilarity, and recommends that sponsors use a stepwise approach in their development of biosimilar products [original FDA emphasis]." One industry commentator nearly-instantly misread this, in our opinion, to mean that FDA was opening a "Pandora's box" of biologics that might be radically different from a branded drug, but had the same therapeutic effect, and were therefore "biosimilar." We think FDA has taken the right step with the totality-of-the-evidence approach, but now the discussion will move to how much evidence is necessary.

Even as industry examines these documents, there's one aspect of their arrival that is troubling. FDA chose to roll this out merely by posting the documents; no press conference, no speech. In Washington, these days, how you announce something is almost as important as what you announce. Picture, for a moment, a press conference led by FDA Commissioner Margaret Hamburg, with BIO's president, Jim Greenwood, on one side, and GPhA's Ralph Neas on the other (and, what the heck, PhRMA's John Castellani at the podium, too.) What would that say about industry's and government's common efforts to resolve the knotty technical issues around biosimilars? Instead (clearly indicating that the documents were in effect dropping from the sky), GPhA could only say that "will carefully review the documents in coming days" and BIO looks forward "to reviewing the drafts to ensure that they agree with our key principles." Which sounds like the drug-review ping-pong game, with FDA being batted back and forth in the middle, is about to recommence.

We'll be following the biosimilar topic on occasion in the future, in keeping with Pharmaceutical Commerce's focus on drugs in, or about to enter, the marketplace. (And we hope that biosimilars arrive sooner rather than later.) One critical element of the change we see coming, derived from some reporting in the Wall Street Journal the day after the announcement, is within this comment: "Manufacturers expect they will have to do more than sell the [biosimilar] therapies based on price, as companies do with traditional generics. They will have to promote biosimilars to doctors, as they do for brand-name drugs."

It's a new world.