FDA clears ‘generic’ auto-trade for branded insulin



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US regulators took action on Wednesday that will make it easier to get a cheaper and closer copy of a brand name insulin at the drugstore.

Doctors must now specifically prescribe what is called a biosimilar or OK by replacing it with a more expensive brand name insulin.

Wednesday’s Food and Drug Administration decision will allow pharmacists to automatically replace the cheaper version, just as they do with generic pills for other types of drugs.

This is the first FDA approval of an “interchangeable” biosimilar, a near-copy of an injected biologic drug that is made inside living cells. This could save diabetics and health plans millions of dollars a year and encourage other drug companies to create more biosimilar drugs. Health data company IQVIA predicts that U.S. savings resulting from the increasing use of biosimilars from 2020 to 2024 will exceed $ 100 billion.

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

Approval of a second interchangeable biosimilar of long-acting insulin appears imminent from the same developers, Pittsburgh-based generic giant Viatris and its partner, India’s Biocon.

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

Red tape, lengthy patents and the decline of brand name drugmakers have limited sales of biosimilars in the United States to well below levels in Europe.

“These products are very similar but much more affordable,” said Sean McGowan, head of biosimilars at AmerisourceBergen, one of the leading drug wholesalers.

To date, only 20 of the 29 biosimilars approved by the FDA – for cancer and immune disorders like rheumatoid arthritis – are sold in the United States, he said.

According to the pharmacy, Semglee injection pens cost around $ 150 to $ 190 without insurance for a typical monthly supply, compared to $ 340 to $ 520 for the same supply of branded Lantus.

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Follow Linda A. Johnson on Twitter: @LindaJ_on Pharma

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

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