Biosimilars, FDA

Senators seek changes to FDA guidance to speed entry of insulin biosimilars

As Eli Lilly announced Monday that it would introduce an authorized generic version of its Humalog insulin at half the original price, four senators on both sides of the aisle are seeking tweaks to recent FDA guidance to speed up the marketing of new biosimilar insulin products.

The guidance is part of FDA’s work to begin, starting in March 2020, transitioning approved marketing applications for a subset of products, including insulin and human growth hormone — previously approved as drugs under section 505 of the FD&C Act — to be biologics.

But questions remain on whether this transition period will briefly halt companies from seeking to bring insulin competition to market.

Sens. Dick Durbin (D-IL), Kevin Cramer (R-ND), Tina Smith (D-MN) and Bill Cassidy (R-LA) wrote in a letter sent Friday to FDA Commissioner Scott Gottlieb that although this FDA guidance will facilitate the submission of biosimilar insulin products for the first time, “the current regulatory framework still introduces perverse incentives that could delay the introduction of low-cost insulin products into the market in the short-term, when they are needed most.”

“Our first concern is that approved insulin ‘follow-ons’ under the FD&C will not transition to biosimilar licenses, meaning they cannot be substituted for brand name versions by pharmacists,” they wrote.

They also take issue, as several others have, with the fact that companies with follow-on insulin applications pending or tentatively approved on 23 March 2020 will be rejected by FDA and have to be re-submitted by the companies.

“If FDA has the ability to offer flexibility in one domain, recognizing the cumbersome requirement to withdraw and re-submit an application, then FDA should offer similar flexibility for pending and/or tentatively approved” insulin applications, the senators write. “No potential applicant who is otherwise prepared to file today would sensibly do so in the face of the looming March 23, 2020 cut-off date—such applicants would instead wait over a year until they would submit under the biosimilar application pathway.”

The senators also seek explanations from FDA, by 15 March, on three issues: “(1) the steps FDA is taking the expedite the approval of insulin follow-on applications prior to the March 23, 2020 deadline, (2) how many applications are currently pending, and (3) whether FDA anticipates approving any insulin follow-on applications prior to the March 23, 2020 deadline.”

In closing, the senators said they “remain concerned the Agency’s 2018 guidance has flaws in the context of insulin products that must be quickly remedied.”

The letter comes as both the House and Senate’s focus on the price of insulin has intensified recently.

Late last month, the Senate Finance Committee began a bipartisan investigation into insulin prices. That move followed similar questions from the House Committee on Energy and Commerce in January seeking more information on the root causes of the rising cost of insulin from the three US insulin manufacturers: Eli Lilly, Novo Nordisk and Sanofi.

In addition, Rep. Peter Welch (D-VT) recently introduced a bill to allow for the importation of insulin from Canada, and later on as FDA sees fit, other similar countries.

Letter to Gottlieb


First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.


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