Trade association names generally fall into two categories: a simple description of who belongs to it; or a prominent stance for (or against) some broad social or business policy issue. With its renaming, announced at its annual meeting on Feb. 14, GPhA is shifting from the first category to the second. And an outsider might well wonder, who could be against access to medicine, such that a trade association needs to actively promote the concept? And, why now?
The ostensible rationale for the name change, as stated by Chip Davis, AAM president, is to emphasize that “Our medicines drive savings, not costs, and we stand ready to work with the President, Congress, patient groups and others to create real and lasting health cost solutions.” There’s no question that the entire pharma industry (indeed, all businesses involved with healthcare) are anxiously watching the swirling activity in the White House and Congress, with the Affordable Care Act on the ropes and President Trump making vague threats about too-high drug prices. On the other hand—as recognized by AAM’s own rebranding announcement, generic drugs now represent 89% of filled prescriptions. Subtract drugs still on patent, and a relatively small number of cases where a patient cannot tolerate the generic version of a branded drug, and the realization is (and has been for several years now) that there’s very little remaining headspace for additional generic substitution. That battle is long over, and generics have resoundingly won.
Nevertheless, AAM is launching a publicity campaign touting the savings and value that generic drugs provide; could be a little bit of rival envy since PhRMA, the home of the branded drugmakers, has a high-profile (and high-cost) “GoBoldly.com” campaign running on network television and elsewhere.
Another part of the story, however, is a word that kept popping up in the AAM renaming announcement: biosimilars. While noting that today’s generics are 80-85% less expensive, on average, than branded products, AAM also asserted that “biosimilars, alternatives to costly brand biologic medicines, could save our health care system up to $250 billion in the next ten years.” Given that specialty products (which are mostly biologics) represent around a third of today’s drug spending, and will represent 50% by 2020 (by some estimates), biologics and biosimilars represent the future direction of the industry.
The AAM rebranding could thus be a certain degree of resetting GPhA’s mission around biosimilar manufacturers, while not abandoning its core constituency of small-molecule generics makers. The regulatory structure around biosimilars is significantly different from that of generic drugs (one obvious example: the concept of “biogeneric” was abandoned several years ago). And there is something of a lobbying-group vacuum around biosimilars: GPhA has had a Biosimilars Council (which is mostly composed of GPhA members who also have ambitions in biosimilars); and there is a Biosimilars Forum, mostly composed of PhRMA or BIO members who are engaged in biosimilar development. For sure, there are a host of lively debates around biosimilar regulation and practices, starting with something as simple as how a biosimilar product should be named.
Another certainty—a sign of the times—is that advances in medicine will be occurring as frequently in Washington Beltway circles as they do in biopharma labs for the foreseeable future.