Nothing generic about this issue.

I knew our cover story about biogenerics was going to be a gutsy pick. Hands down, it’s the most visceral topic in the industry. Established manufacturers rightly argue there is no such thing as an exact copy of a protein-based therapy, while third-party payers, patient advocates, and a long line of generics manufacturers — many of them overseas — lean on Congress to pressure the U.S. Food and Drug Administration to find a way to make it happen anyway. MICHAEL D. DALZELL If anything, I was reminded just how dug in both sides are when I heard from a representative of the generic drug industry as we were preparing this article for publication. She objected to our use of the term follow-on biologics, with an air that suggested “You’re one of them, not one of us.” We’re not one of anyone, thank you. We’re here to report on developments in the industry and let payers and clinicians draw their own conclusions. In the sincere interest of learning, I asked her — twice — what term the generics industry prefers to describe bio-similars, biogenerics, copycats, you name it. She never responded. Senior Contributing Editor John Carroll does some fine reporting in describing how generics manufacturers are preparing for the inevitable day when biosimilars can be marketed in the United States. He notes which products are likely to be the first follow-ons, with the implication that some of biotech’s big boys could be belted. When that day comes, the market will develop quickly. The FDA has more than just a regulatory pathway to worry about. China makes more than 20 biopharmaceuticals, many of them generics, and ships raw materials for drugs to U.S. generics manufacturers. Against a background of tainted Chinese products entering the United States, poor regulatory oversight in China, and an understaffed FDA, the real worry about biowhatchamacallits may come from the Pacific Rim. (China says it is cracking down. It recently sentenced the former head of its FDA-equivalent agency to death for actions that contributed to this mess, so China must really mean it now. But I digress....) Another must read is Contributing Editor Lola Butcher’s piece on prior authorization giving way to other utilization management techniques for some biologics. For too long, payers have applied old-world cost controls to the new world of biologics, without much to show for it. Now, some innovative health plans are engaging in out-of-the-mold thinking that could lead to a new and refreshing collaboration between payers and providers. There’s something here for everyone. Enjoy the issue — and the rest of this glorious summer.