In order to pass this test - and demonstrate biosimilars can have a strong, healthy future in the U.S. If biosimilars come up short again, Wosińska and others worry about the chilling effect that could have on future biosimilar investments, leading to less competition and a future where people pay higher drug prices, steeper insurance premiums and bigger tax bills for programs like Medicare. "Tons of money on the table eight companies ready to jump in." "All of the pieces seem to be there," Wosińska said. Humira offers by far the best opportunity this beleaguered market has had to succeed. Experts debate whether those unique challenges have doomed this market or if biosimilars simply need more time to establish themselves. In contrast, because biologic drugs are grown in living cells, they are harder to mimic, making biosimilars more difficult and expensive to manufacture. Conventional drugs can be replicated like a recipe in a cookbook using chemical processes. Unlike generics, biosimilars face a unique set of regulatory, manufacturing and business challenges. How biosimilars are different from generics patients and insurers $300 billion a year. in 2015, biosimilars have struggled to match the market-devouring, price-plummeting impact of generic drugs, which save U.S. drug spending despite comprising less than 3% of prescriptions. Biologics account for nearly half of U.S. While biologics are driving many of medicine's most exciting new advances - shrinking tumors, controlling diabetes, even delaying dementia - they are also consuming more of our money. Shots - Health News FDA-Approved Knock-Offs Of Biotech Drugs Could Safely Save Big Bucks A golden opportunity for a beleaguered biosimilars marketīiosimilars are highly similar versions of a rapidly growing class of drugs called biologics, a broad range of treatments or preventatives that include immunotherapies, insulins and certain vaccines made from living cells. It's a market critical to containing drug costs in the U.S., which relies primarily on competition rather than regulation to rein in spending. Humira losing its monopoly creates the biggest test the fledgling U.S. "I am pretty anxious," said Marta Wosińska, an economist and fellow at the Brookings Institution. Other groups representing insurers, patients or employers are also eager for these biosimilars to usher in more competition - in hopes that will enable them to slash their spending on the popular treatment.īut among industry watchers, the prevailing sentiment is uncertainty over whether competition alone will bring the price down. Awsare, associate executive director for the Permanente Medical Group, advises national insurer Kaiser Permanente on its prescription drug policies. "It's about time!" said Sameer Awsare with a laugh and a smile. At least seven more Humira copycats, known as biosimilars, are expected to debut later this year. Early Tuesday morning, California-based biotech firm Amgen released Amjevita, the first close copy of the best selling drug of all time. Some patients spend $70,000 a year on Humira.Īfter 20 years and $200 billion in revenue, Humira - an injectable treatment for rheumatoid arthritis and several other autoimmune conditions - has lost its monopoly. Humira, the injectable biologic treatment for rheumatoid arthritis, now faces its first competition from one of several copycat "biosimilar" drugs expected to come to market this year.
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