FDA allows automatic “universal” exchange of branded insulins

US regulators took action on Wednesday to make it easier to buy branded insulins that are cheaper and close to generic drugs in pharmacies.

Doctors must now specifically prescribe so-called biosimilars or OK to replace the more expensive branded insulin.

The US Food and Drug Administration’s action on Wednesday will allow pharmacists to automatically substitute cheaper versions, just like their generic drugs for other types of drugs.

This is the first time the FDA has approved “interchangeable” biosimilars, an approximate replica of an injectable biologic drug manufactured in living cells. It can save diabetics and health plans millions of dollars each year, and encourage other drugmakers to develop more biosimilars. Health data company IQVIA predicts that from 2020 to 2024, the United States will save more than US$100 billion by increasing the use of biosimilars.

The FDA agrees that Viatris Inc.’s Semglee is interchangeable with the widely used fast-acting insulin Lantus.

The same developer of Pittsburgh-based generic drug giant Viatris and its partner India Biocon appears to be about to approve a second such interchangeable long-acting insulin biosimilar.

Mylan NV was one of the two companies that merged to create Viatris in December last year, and launched Semglee in the United States last summer.

Red tape, lengthy patents, and resistance from brand-name drugmakers have restricted the sales of biosimilars in the United States far below European levels.

“These products are very similar, but at a much cheaper price,” said Sean McGowan, director of biosimilars at AmerisourceBergen, a top drug wholesaler.

He said that so far, only 20 of the 29 biosimilars approved by the FDA (used to treat immune diseases such as cancer and rheumatoid arthritis) are sold in the United States.

Depending on the pharmacy, the price of the Semglee injection pen is about US$150 to US$190, without insurance, and usually a one-month supply, while the same supply of the brand Lantus is US$340-520.


Follow Linda A. Johnson on Twitter: @LindaJ_on Pharma


The Associated Press Department of Health and Science is supported by the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.

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