FDA Biosimilar Interchangability Regulations Completed

[lord999]

FDA finalizes guidance to spur biosimilar availability

The guidance will help companies develop biosimilars that can be interchanged at the pharmacy without the need to contact a doctor.

www.modernhealthcare.com

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on policy advancements to help bring interchangeable biosimilars to market

FDA announces final guidance on the pathway for “interchangeable” biologics, which may be substituted without the involvement of the prescriber.

www.fda.gov

That's going to be very interesting for BIO. I wouldn't suggest dumping your Amgen or Genentech yet, but the biologics market is going to be interesting in about five to seven years from now.

 

[BigBoss]

Developing biosimilars for biologics seems like a daunting task since most all of them are monoclonal antibodies.

 

[cgfpharm]

According to this link (https://www.fda.gov/media/89589/download), still in Aug/2019 there are no interchangeable approved drugs?

 

[lord999]

According to this link (https://www.fda.gov/media/89589/download), still in Aug/2019 there are no interchangeable approved drugs?

Yeah, remember how long NDA's take to go through? Still has to get the NDA although not necessarily the IND depending on aspects of the guidance.