biosimilar

Top-Selling Drugs About to Lose Patent Protection

The pharmaceutical industry is about to fall off a cliff -- a patent cliff. Over the next few years, some of the world's most popular and lucrative medicines will go off patent, and generic competition will siphon an estimated quarter of a trillion dollars from companies' bottom lines. Here's a rundown:

How to Approve 'Biosimilar' Drugs? The FDA Has to Figure That Out

Unlike generics, which are the exact chemical copies of a brand-name drug, biosimilars have large and often complex proteins that are made in living cells, and tiny differences can play havoc with the product. It may take years for the FDA to create an approval process.

Pfizer Pushes into Biotech Generics

Pfizer may be hatching plans to sell "biosimilars," cheaper versions of biotech medicines, of drugs developed by the world's largest independent biotech Amgen. That's causing concern not just at Amgen, but at other biotechs that fear such competition.