Insulin designated biologic in ‘landmark moment’

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Prostock-Studio)
(Image: Getty/Prostock-Studio)

Related tags: Insulin, Biosimilars

Manufacturers can now apply to the US FDA for the approval of biosimilars to insulin products.

Yesterday, the US Food and Drug Administration (FDA) welcomed a ‘new era’ of biosimilar interchangeable insulin products as a result of a designation change including insulin products as biologics, which arrived after being announced a decade ago.

Due to the designation change, the FDA stated that the cost of insulin could be ‘potentially reduced’ and patients would provide greater access to products, with more choice.

The cost of insulin products has become a major point of contention, to the point where multiple FDA commissioners, from Scott Gottlieb​ to Ned Sharpless​, have stated that the price burden of the products is a problem – one which biologic designation could help with.

It is estimated that the US healthcare system spends $330bn (€291bn) on insulin products annually.

In its latest release, the FDA stated, “Today’s transition opens a new pathway for manufacturers to seek FDA approval of and bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition.”

The agency’s own analysis suggested that biosimilar competitors to biologic products introduced onto the US market were launched with list prices 15% to 35% lower.

Further than this, the agency explained that it “stand[s] ready to review incoming applications from industry.”

The only problem is whether there are products in the pipeline ready to pursue the application process immediately.

When BioPharma-Reporter spoke to Sandoz about its plans to launch an insulin biosimilar in the US, it could only confirm that it had one compound going into Phase II trials​, this time last year.

In the meantime, the manufacturers of existing products have moved to reduce the price, ahead of biosimilar competition and in the face of growing criticism from the US Senate​.

Once there are biosimilar competitors on the market, there will be the additional hurdle to face in seeing widespread adoption and achieving the full potential savings. A recent report​ analyzed the current biosimilar market in the US and noted that the country was currently missing out on annual savings on currently approved biosimilars to the sum of $7.2bn.

Related topics: Markets & Regulations, Biosimilars

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