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).
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
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.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.