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.
Industry watchers expect biosimilars for AbbVie's Humira to be the most successful copycat biologics launched in the U.S. and Europe, and that's something Merck and Samsung are trying to get in on.
With biosimilars makers eager to grab a piece of Humira's $12.5 billion-plus revenue, copies of AbbVie's blockbuster are on their way. What analysts disagree on, though, is when they'll arrive and how long it'll take them to make their presence known--and a pair of UBS analysts, for one, thinks the Illinois pharma has some marketing maneuvers up its sleeve to minimize their impact.
Drug companies in India's leading industrial state of Gujarat, the base of Prime Minister Narendra Modi, are stepping up efforts to crack the domestic market for biosimilars as well as abroad, Business Standard reports.
The cost-effectiveness watchdogs at the National Institute for Health and Care Excellence have put their money behind biosimilars. Remicade biosimilars, to be exact, in new guidance for treating rheumatoid arthritis.
A move by Australia to be the first country to allow pharmacies in some cases to substitute biosimilars for originator drugs has drawn a rebuke by the U.S.-based Alliance for Safe Biologic Medicines, which includes members such as Amgen and the Biotechnology Industry Organization.