FDA decides in favor of innovator biotechs in biosimilar naming conventions

Among the multiple issues complicating the introduction of biosimilar products into the US market, naming conventions have been a prominent one. The innovator companies have favored a convention that would distinguish their product from subsequent biosimialrs; the biosimilar community (such as it is—some biotechs are busy developing biosimilars themselves), has favored no distinctions, citing the precedent of small-molecule generics, which get listed under the same generic name as the originator product. After years of tussling with the issue internally, FDA has come out with proposed guidance favoring the differentiated approach. All biopharmaceuticals (including the originator product) would have a nonproprietary name (formally, the “International Nonproprietary Name,” or INN) followed by a four-letter suffix. For example, FDA suggests that Amgen’s Neuprogen (filgrastim) would henceforward be named “filgrastim-jcwp,” while Sandoz’ Zarxio product (recently approved by FDA) would be called “filgrastim-bflm.” (The four-letter suffix is intentionally meaningless; FDA had tentatively named Zarxio as “filgrastim-sndz” earlier this year.)

The Biosimilars Council, a group organized under the Generic Pharmaceutical Assn., immediately issued a statement: “The FDA’s proposals today on naming conventions for biosimilars warrant serious scrutiny for their potential to erect barriers to patient access to new, more affordable medicines, and jeopardize their safety,” said Dr. Bertarm Liang, chairman, adding that “. Adding a random collection of letters to the product’s nonproprietary name confers no additional safety benefit, and in fact would require the healthcare professional to be armed at all times with a code-breaking reference.”

Curiously, neither BIO (the main organization of biotechnology companies) nor the Alliance for Safe Biologic Medicines have issued any statement, as of Aug 31 (click here for the ASBM response issued on Sept. 1). The Alliance, in particular, has been actively promoting differentiated naming, going so far as to lobby state pharmacy boards and legislatures to build in methods to differentiate originator from follow-on products. BIO has its own internal cognitive dissonance to deal with; as it also represents agricultural biotech, it has been busy lobbying against distinguishing food products that are “natural” (whatever that means) from foods derived from genetically modified organisms (GMOs). (Just last month, BIO issued a press release in favor of HR 1599, passed in the House of Representatives, which precludes state GMO-labeling rules; GMO opponents call that bill the “Denying Americans the Right To Know” or “DARK” Act.)

The FDA proposed guidance (which will be subject to commentary for the next 60 days, after which a final rule might be issued) also asks whether biosimilars that have been judged to be “interchangeable” (which has a distinct meaning under the evolving FDA framework) should have the same suffix as the originator product—but the interchangeability designation might not happen at the same time as a biosimilar’s approval. The Biosimilars Council notes that several already-approved biosmilars in the EU and elsewhere, without a naming distinction, are being prescribed thousands of times without a major hiccup. Ronald Rader, proprietor of a biotech publishing company (Biotechnology Information Institute, in Rockville, MD) notes that FDA has missed the chance to incorporate naming conventions into a host of related products, including vaccines, cellular therapies and others, which are coming forward.

Payers if not prescribers

Why these naming conventions are important is based on the assumption that a) some prescribers and some patients will insist on receiving the originator product even if a less-expensive biosimilar is available; and b) there will be adverse events with biosimilars that need to be differentiated by which product was being used. Both these points are debatable: the Biosimilars Council notes that “Adverse events and product recalls for small-molecule and biologic drugs already are successfully identified using the national drug code (NDC code), and lot number and company name, and there is no compelling evidence that biosimilars should be handled differently.” (Meanwhile, an issue that has been lurking around the small-molecule generics world is adverse events of those products, which is something that FDA has mostly failed to address.)

On the pricing and substitution front, the trend has been for patients and prescribers tied to the major pharmacy benefit managers (PBMs), to be compelled to using the lowest-cost products across the board, through mechanisms like step edits, copay tiers and the like. Figuratively speaking, while FDA splits hairs with naming conventions, in the commercial world, PBMs use a baseball bat to compel compliance. On the other hand, Peter Pitts, president of the Center for Medicine in the Public Interest (New York), and a strong supporter of distinct naming conventions, noted in a posting after the FDA announcement that CMS is not mandating separate J Codes in its Healthcare Common Procedure Coding System—a decision which, if it stands, subverts the FDA proposed guidance, at least for drugs that are reimbursed under a medical benefit as opposed to a pharmacy benefit.

No one in the biosimilars debate seems to be taking cognizance of what will eventually happen with drug distribution: In the next several years, as the requirements of the Drug Supply Chain Security Act (DSCSA) come into force, it will be possible to track individual prescription packages from point of origin to point of dispensing. If everyone in the supply chain (distributors, dispensers and healthcare organizations) does what it is supposed to, it will be possible to tie a patient outcome or adverse event to the specific drug, and its source. Adding the DSCSA serial data to prescriptions and claims forms is certainly doable, but that might be a bridge too far for healthcare providers.