As the world's best-selling drug, AbbVie's Humira has a biosimilar target painted on its back--and Baxalta is the latest to take aim.
Right now, Novartis' Sandoz has the only biosimilar on the U.S. market. And it's looking to make it two.
Roche has been facing pricing pushback for its breast cancer drug Kadcyla in the U.K., with the country's cost watchdog nixing the med last year and the Cancer Drugs Fund recently rejecting it from its covered list. Now, patients are voicing their discontent, calling on Britain's health minister to override the company's Kadcyla patents and open the door for lower-priced copies.
A rope-a-dope strategy of sorts on biosimilars is in play for India's Dr. Reddy's as it shifts from a strategy of racing to the domestic market with products in favor of a coiled approach that will let it strike out in several markets in a burst.
Two weeks ago, Novartis launched a copy of Amgen's Neupogen (filgrastim), its first in what it expects to be a thriving business in biosimilars, in the U.S. In anticipation of big sales, its Sandoz unit has now opened a plant in Austria to make the autoinjectors that will dispense the drugs.
The industry has been wrestling for years now over naming the first wave of biosimilars building on the coast of the American drug industry. The FDA's suggested solution: Take the generic name and add four random letters to make it a unique identifier.
After much industry lobbying and public debate, the FDA has proposed a system for naming biosimilar drugs. It's a sort of hybrid of the generic name on one hand and the unique brand name on the other. And it would allow the FDA to make some biosims easy to substitute for the brand-name original--and others not so easy.
South Korea-based Samsung Bioepis has hired lead managers for a U.S. listing next year as the joint venture between Samsung Group and Biogen looks to raise as much as $1 billion to fund development of biosimilars that will compete with some of the world's best-selling drugs, Reuters reports.
Drugmakers are well aware of the biosimilars threatening to steal sales and market share from some of the world's best-selling biologics. Doctors, though? Not so much, a new report suggests.
Biosimilar competition may take a bigger bite out of branded sales than we think. The top 10 biologics facing biosimilar competition will see sales fall to $49 billion by 2020, consensus estimates say. That's down from $62 billion last year. But according to Morningstar analysts, that 2020 sales number is too high.