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.
Not only is April Financial Literacy Month, it’s also the kickoff of the spring homebuying season. So now is the time to make sure you have a financial plan in place – and why it might not be wise for that to include buying your first home.
While the U.S. may slowly be on the path to lowering inflation (and therefore interest rates), Europe has thoroughly trounced America, putting it on the path to lower rates by this summer.
April's release of the monthly Housing Starts and Building Permits reports by the Census Bureau provides crucial insights into the construction activity in the housing market. These reports are an economic indicator, shedding light on the current state of the housing market and its broader economic impact.
Caitlin Clark is heading to the Indiana Fever, the number one draft pick and the highest-scoring college basketball player of all time. And while she may not be getting millions from the WNBA, there's a few ways she'll net compensation for her generational talents.
Author of 'Clean Meat,' Paul Shapiro joins Cheddar to discuss how the cellular agricultural revolution helps lower rates of foodborne illness and greatly improves environmental sustainability. Plus, how his company The Better Meat Co. is bringing healthier food options to the table.
Recent headlines might make it sound like World War III is imminent, but when it comes to your finances, it's not the time to panic. The market is coming off its longest winning streak since 2011.
You may have noticed fewer new venture capital-backed startups (like Airbnb or Uber) lately. The market slowed to a crawl after 2021, but things are expected to take off again in 2025.
Corporate earnings season is underway, that time when companies share their billions in sales or double-digit profits. But the data shows even companies are struggling with high inflation and interest rates.
Boeing continues their terrifying trend of having their planes fall apart mid-flight, inflation — checks notes — is still up and the future of AI looks terrifying. Cheery!
Food waste – uneaten scraps or leftovers sent to landfills – is responsible for 10% of global emissions. Mill, a new product from the co-founder of Nest, thinks technology can play a role in eliminating it.
