The Appropriations Bill Alters Insulin Biosimilar Rules

Closing out the week before the holidays, the House and Senate’s Appropriations Bill specified two significant passages that affect the March 22, 2020 transition date for insulins being approved under the 351(k) pathway. Here’s a summary of these two points.


On December 17, 2019, two Food and Drug Administration senior executives released a joint statement to clarify a key point on the upcoming biosimilar insulin transition. In March of 2020, insulins will be among several drug classes that will be transitioned to the 351(k) biosimilar pathway. However, Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs, and Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research, pointed out that this transition currently applies only to protein products that are not chemically synthesized. That is, if the insulin is a synthetic analog and not considered a human insulin, or produced through recombinant RNA technology, it will continue to be subject to the 351(a) pathway.

“Such a product would also not be able to come to market through the generic drug pathway because the originator product will have been classified as a biologic, and will not be available for copying. This exclusion could hurt potential competition because it means that if a developer were to chemically synthesize a copy of a protein product (e.g., an insulin copy), the product would not be able to come to market through the abbreviated biosimilar or interchangeable pathway,” stated Ms. Abram and Dr. Woodcock.

In the latest House and Senate appropriations bill, the notation was made to strike this exclusion from the definition of a biologic: “Section 351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1)) is amended by striking “(except any chemically synthesized polypeptide).” [I needed help to find the relevant passage—on page 1503.]

Dr. Woodcock and Ms. Abram explained, “Removing this exclusion will help patients because it provides the potential for chemically synthesized follow-on insulins and other protein products to come to market through more efficient abbreviated pathways, regardless of how they are manufactured. In addition to expanding access to lower-cost biosimilar and interchangeable protein products, removing this exclusion will help to promote potential innovation in manufacturing methods, which could lead to future efficiencies in manufacturing processes.”


Another clause in the Appropriations Bill helps Mylan and Biocon out of a big jam: The partners, which received a complete response letter in late September for its insulin follow-on agent, were facing a real issue in March 2020. If they did not receive approval by this date (that of the insulin transition to biosimilar status), they would have to resubmit their 505(b)2 new drug application as a 351(k) biosimilar and start from scratch. Instead, the Appropriations Bill includes a clause that spares them and other prospective insulin manufacturers with active applications this fate.

Under the Bill’s language, “With respect to an application for a biological product submitted under subsection (b) or (j) of section 505 of the Federal Food, Drug, and 12 Cosmetic Act (21 U.S.C. 355) that is filed not later than March 23, 2019, and is not approved as of March 23, 2020, the Secretary shall continue to review such application under such section 505 after March 23, 2020.”

In other words, if the application for a new insulin follow-on agent was already underway before March 22, it can continue as such throughout the approval process. This new language does not resolve the problem of a “gap year” as Gillian Woollett of Avalere terms it; it will still take around a year after March 22 for new 351(k) applicants to receive an FDA decision on their insulin biosimilar. However, it does mean that we may see a new follow-on insulin approved during that time.

In Other Biosimilar News…Partners Amgen and Allergan have submitted a 351(k) application for their rituximab biosimilar ABP 798 to the FDA. The clinical studies for this drug were conducted in patients with rheumatoid arthritis and in those with non-Hodgkins lymphoma, which would differentiate the agent somewhat from the other rituximab biosimilar approvals, which focus only on Rituxan’s oncology indications. Based on the submission date, an FDA decision can be expected in Q4 2020.

And with that, we’ll be disconnecting for a couple of weeks. From all of us at BR&R, we wish you a happy and safe holiday season!

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