Health

The FDA authorizes automatic replacement of generic insulin with branded insulin.

On Wednesday, US regulators took steps to make it easier to get a cheaper, nearly complete copy of branded insulin from the pharmacy.

Doctors now have to specifically prescribe a so-called biosimilar drug, or OC, replacing it with more expensive branded insulin.

The FDA’s decision on Wednesday will allow pharmacists to automatically replace the cheaper version, just like they make regular pills for other types of drugs.

This is the first FDA approval of a “interchangeable” biosimilar, almost a copy of an injected biological drug that is produced inside living cells. This could save diabetics and insurance companies millions of dollars annually and encourage other drug manufacturers to create more biosimilar drugs. Health data firm IQVIA predicts US savings from increased 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 fast acting insulin.

The approval of the second such interchangeable biosimilar long-acting insulin is inevitable from the same developers, generics giant Viatris from Pittsburgh and its partner, the Indian company Biocon.

Mylan NV, one of two companies that teamed up to create Viatris last December, launched Semglee in the US last summer.

Due to bureaucracy, long-term patenting and opposition from well-known drug manufacturers, sales of biosimilars in the United States turned out to be much lower than European ones.

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

According to him, only 20 of the 29 FDA-approved biosimilar drugs for the treatment of cancer and immune disorders such as rheumatoid arthritis are sold in the United States.

Depending on the pharmacy, Semglee injection pens cost between $ 150 and $ 190 without insurance for a typical monthly supply, compared to $ 340-520 for the same stock of branded Lantus.


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