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.
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).
AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access
April 24th 2024Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.