This July 2021 image provided by Viatris shows Semglee insulin. On Wednesday, July 28, 2021, U.S. regulators took action that will make it easier to get a cheaper and similar version of a brand-name insulin at the drugstore. The Food and Drug Administration agreed that Viatris Inc.’s Semglee was interchangeable with widely use Lantus, a fast-acting insulin. (Viatris via AP)
By Linda A. Johnson
U.S. regulators took action Wednesday that will make it easier to get a cheaper, near-copy of a brand-name insulin at the drugstore.
Doctors now have to specifically prescribe what’s called a biosimilar or OK substituting it for a more expensive brand-name insulin.
Wednesday’s move by the Food and Drug Administration will allow pharmacists to automatically substitute the cheaper version, just as they do with generic pills for other kinds of drugs.
It’s the FDA’s first approval of an “interchangeable” biosimilar, a near-copy of an injected biologic medicine that’s manufactured inside living cells. It could save diabetics and health plans millions of dollars annually and encourage other drugmakers to create more biosimilar medicines. Health data firm IQVIA projects U.S. savings from increasing use of biosimilars from 2020 through 2024 will top $100 billion.
The FDA agreed that Viatris Inc.’s Semglee was interchangeable with widely used Lantus, a fast-acting insulin.
Approval of a second such interchangeable biosimilar of a long-acting insulin appears imminent from the same developers, Pittsburgh-based generic giant Viatris and its partner, India’s Biocon.
Mylan N.V., one of two companies that merged to create Viatris last December, launched Semglee in the U.S. last summer.
Red tape, lengthy patents and pushback from brand-name drugmakers have limited U.S. sales of biosimilars to far below levels in Europe.
“These products are highly similar but much more affordable,” said Sean McGowan, head of biosimilars at AmerisourceBergen, a top drug wholesaler.
Only 20 of 29 FDA-approved biosimilars — for cancer and immune disorders like rheumatoid arthritis — are sold in the U.S. so far, he said.
Depending on the pharmacy, Semglee injector pens cost about $150 to $190 without insurance for a typical month’s supply, compared to $340 to $520 for the same supply of brand-name Lantus.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
An independent watchdog within the IRS reports that while taxpayer services have vastly improved, the agency is still too slow to resolve identity theft cases. And National Taxpayer Advocate Erin Collins says those delays are “unconscionable.” Erin M. Collins said in the report released Wednesday that overall the 2024 filing season went smoothly, though IRS delays in resolving identity theft victim assistance cases are worsening. It took nearly 19 months to resolve self-reported identity theft cases as of January, and Wednesday's report states that now it takes 22 months to resolve these cases.
Amazon.com Inc. surpassed $2 trillion in market value for the first time in afternoon trading on Wednesday. The push higher for Amazon’s stock market valuation comes a little more than a week after Nvidia hit $3 trillion and briefly became the most valuable company on Wall Street. Nvidia’s chips are used to power many AI application and its valuation has soared as a result. Amazon has also been making big investments in AI as global interest has grown in the technology. Most of the company’s focus has been on business-focused products.
Climate change doesn’t just mean more extreme weather – it also leads to billions of dollars in lost productivity, tourism, and stresses infrastructure.
It’s an annual tradition: the Fed’s banking ‘stress test.’ A year after the regional banking crisis, there are good reasons to make sure they’re prepped.
Summer is upon us, which means weddings, trips overseas, and trips to see Taylor Swift. Avoid a “Cruel Summer” with these budget-friendly tips and tricks.
While Nvidia's meteoric rise led it to briefly dethrone Microsoft as the world's biggest public company, there's a lot more going on in this market than A.I.
