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The FDA allows automatic “general” swapping of brand name insulin

US regulators took steps on Wednesday to make cheap near-copies of brand-name insulin readily available at drug stores. Doctors need to specifically prescribe what is called a biosimilar. Wednesday’s move by the Food and Drug Administration will allow pharmacists to automatically replace cheaper versions, just like generics of other types of drugs. This is the FDA’s first approval of a “replaceable” biosimilar, an injected biopharmaceutical manufactured in living cells. It could save millions of dollars a year in diabetics and health insurance and encourage other pharmaceutical companies to create more biosimilar medicines. Health data company IQVIA predicts US savings of more than $ 100 billion by increasing biosimilar use between 2020 and 2024. The FDA has agreed that Viatris Inc.’s Semglee is compatible with Lantus, a widely used fast-acting insulin. Biosimilars for long-acting insulin appear to be imminent from the same developer, Pittsburgh-based generic giant Beatrice and its partner, Biocon in India. Mylan NV, one of the two companies that merged to create Beatrice last December, launched Semglee in the United States last summer. “These products are very similar, but much more affordable,” said Sean McGowan, head of biosimilars at Ameri SourceBergen. Wholesaler. Of the 29 FDA-approved biosimilars, only 20 have been sold in the United States to date due to immune disorders such as cancer and rheumatoid arthritis, he said. Compared to $ 340- $ 520 for the same supply of brand name Lantus. The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.

US regulators took action on Wednesday, making cheap near-copies of brand-name insulin readily available at drug stores.

Doctors now need to specifically prescribe what is called a biosimilar. It can be used in place of the more expensive brand name insulin.

Wednesday’s move by the Food and Drug Administration will allow pharmacists to automatically replace cheaper versions, just like generics of other types of drugs.

This is the first FDA approval of an “exchangeable” biosimilar that is close to a copy of an injected biopharmaceutical produced in living cells. It could save millions of dollars a year in diabetics and health insurance and encourage other pharmaceutical companies to create more biosimilar medicines. Health data company IQVIA predicts that increasing biosimilar use between 2020 and 2024 will save more than $ 100 billion in the United States.

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

Approval of a second such compatible biosimilar for long-acting insulin appears to be imminent from co-developer Pittsburgh-based generic giant Viatris and its partner Biocon in India. is.

Beatrice via AP

This July 2021 image provided by Viatris shows Semglee insulin. On Wednesday, July 28, 2021, US regulators took steps to make it easier to obtain cheaper and similar versions of brand-name insulin in drugstores.

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

Due to bureaucracy, long-term patents, and backlash from well-known pharmaceutical companies, biosimilar sales in the United States are well below European levels.

“These products are very similar, but much more affordable,” said Sean McGowan, head of biosimilars at top drug wholesaler AmerisourceBergen.

Of the 29 FDA-approved biosimilars, only 20 have been sold in the United States so far for immune disorders such as cancer and rheumatoid arthritis, he said.

Depending on the pharmacy, the Semglee injector pen costs about $ 150 to $ 190 without insurance on a regular monthly supply, but $ 340 to $ 520 with the same supply of the brand name Lantus.

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

The FDA allows automatic “general” swapping of brand name insulin

Source link The FDA allows automatic “general” swapping of brand name insulin

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