Eli Lilly Hints That It May Pursue "Branded Biosimilars" of Its Own Products

The comment period has recently closed for the FDA’s proposed approach to the transition of insulins and other products that have historically been regulated as drugs and follow-ons to regulation as biologics and biosimilars, and among the comments from stakeholders is a suggestion that one drug maker may be interested in selling biosimilars of its own products.

In its comments, Eli Lilly and Company voiced its support of the FDA’s proposed approach to the transition of products that are currently addressed under the Federal Food, Drug, and Cosmetic Act to regulation under the Public Health Service Act in 2020. Notably, however, the company called on the FDA to clarify whether drug product developers can introduce “second versions” of their innovator biologics, calling these potential products “branded biosimilars” or “authorized biologics.”

“Clarity regarding the appropriate regulatory mechanisms for launch of these products as well as applicable naming and interchangeability policies will provide stakeholders with greater certainty, help all sponsors plan their development programs and, ultimately, help to give patients more therapeutic options,” wrote Salvador Manuel Garcia de Quevedo Pérez, senior regulatory director of the company, in his comment letter.

The comment calls on the FDA to explain whether a branded biosimilar would need to have a different 4-letter suffix than the reference product, and whether any special naming considerations could be applied to such product (for example, whether the products could have the same or different proprietary names as their references).

“Sponsors of innovative biological products already are endeavoring to market second versions of their products in ways that allow them to increase patient access,” wrote Pérez, adding, “Clear direction from FDA on marketing these second versions of innovative products will help all sponsors plan their product development programs and, ultimately, benefit patients.”

Lilly’s comments suggest that the company may be interested in selling its drugs under brand names as well as under a structure similar to that used for authorized generic drugs; authorized generics are the same products as brand-name small-molecules with respect to active ingredients, conditions of use, dosage, strength, and route of administration, but may have minor differences (such as different inactive ingredients or different colors or markings) and are not sold under the branded drug’s name.

Examples of such authorized generics are versions of Gilead’s hepatitis C treatments Harvoni and Epclusa that carry list prices of approximately one-third of the originator drugs.

Lilly’s products that will be affected by the transition, and which may be subject to Lilly’s interest in branded biosimilar development, are insulin glargine (Basaglar, a follow-on insulin referencing Lantus), human insulin (Humalin), insulin lispro (Humalog, which already faces follow-on competition form Sanofi’s Admelog), and the growth hormone somatropin (Humatrope).