FDA Approves First Lower-Cost Biotech Drug
Posted: Sun Jun 07, 2015 5:27 pm
This is an unexpected surprise and a game changer.
[quote=http://www.nytimes.com/aponline/2015/03 ... h-fda.html]In the U.S., pharmacies and insurers cannot automatically switch patients from a brand-name biologic to a biosimilar, which is allowed for generic versions of traditional drugs. But if state law allows, pharmacists could call doctors and ask them to consider such switches, FDA officials said.
And if biosimilar drugmakers apply to the FDA for a designation called "interchangeability," automatic switches to the cheaper biosimilar drug would be allowed. Novartis didn't seek that classification for its drug, but analysts expect other companies will, expanding the market for biosimilars to $20 billion by 2020, according to Leerink Swann analysts.[/quote]
[quote=http://www.nytimes.com/aponline/2015/03 ... h-fda.html]In the U.S., pharmacies and insurers cannot automatically switch patients from a brand-name biologic to a biosimilar, which is allowed for generic versions of traditional drugs. But if state law allows, pharmacists could call doctors and ask them to consider such switches, FDA officials said.
And if biosimilar drugmakers apply to the FDA for a designation called "interchangeability," automatic switches to the cheaper biosimilar drug would be allowed. Novartis didn't seek that classification for its drug, but analysts expect other companies will, expanding the market for biosimilars to $20 billion by 2020, according to Leerink Swann analysts.[/quote]