Comments on FDA’s plans to transition insulin products

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The US Food and Drug Administration (FDA) held a public meeting on the 13 May 2019 to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products.

Insulin 2 V13E10

Part of these plans include the transition of biologicals currently approved under the Food, Drug, and Cosmetic Act (FD&C Act) of the Public Health Service Act. This, according to the agency, ‘will open the pathway to market new products that are biosimilar to, or interchangeable with, these transitioned products’. The biologicals affected by this transition include insulin products, insulin mix products and insulin analogue products (insulin products).

For historical reasons these products were previously approved under the FD&C Act as drugs, but from March 2020 will be deemed to be biologicals. FDA released guidance describing how it intends to accomplish the transition of these products under the ‘Deemed to be a License’ provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), in December 2018 [1].

According to acting FDA Commissioner, Ned Sharpless, there has been ‘a continuing increase in the prices of insulin products’. He pointed to a study from the Schaefer Center, which ‘documented that the average list price of four insulin categories increased on the order of 16% annually from 2012 to 2016’ and a report released in 2018 by the Congressional Research Service, which ‘noted that the list price of one type of insulin had increased nearly 600% from 2001 to 2015’.

The meeting was therefore held in order to gain input from stakeholders about what factors FDA should consider in evaluating information submitted by applicants for new insulin biosimilars. The agency also wanted input on what scientific standards they should be using for evaluating, within the bounds set by the statutory requirements, whether an insulin product is biosimilar or interchangeable to a reference product. In addition, the agency wanted to discuss whether certain products, like insulin pumps for continuous subcutaneous infusion, raise unique scientific considerations that should be considered when evaluating biosimilar or interchangeable insulin products. Finally, FDA also wanted to know what kinds of information and resources it needs to develop to foster effective communications and promote awareness among patients, clinicians, pharmacists and other stakeholders about biosimilar and interchangeable insulin products.

Several stakeholders explained how patients currently switch between different insulin products, raising the question of why there should be two distinct categories for insulin biosimilars and interchangeable insulins. It was also pointed out that there could be unintended consequences with the two separate designations, which patients might find confusing.

The Association for Accessible Medicines, while applauding FDA’s efforts to bring insulin biosimilars to the market, urged the agency to emphasize that interchangeability does not confer quality but is a statutory standard for automatic substitution. While others, such as Mylan’s head of global clinical research, Abhijit Barve, stressed the need for streamlined approaches to developing interchangeable insulins.

Eli Lilly, on the other hand, which makes the originator insulin product Humalog (insulin lispro), called for switching studies. The company announced in May 2019 that it had launched the lower-priced authorized biosimilar version of its diabetes treatment Humalog (insulin lispro) in the US [2].

Source: AAM, Federal Register, RAPs, US FDA

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FDA to hold public meeting on access to affordable insulin

1. GaBI Online - Generics and Biosimilars Initiative. FDA releases guidances and proposed rule to advance biosimilars policy framework []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 14]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Eli Lilly launches lower-priced insulin lispro []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 14]. Available from:

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