The Medical Letter on Drugs and Therapeutics
FROM
ISSUE
1513
Inflectra - An Infliximab Biosimilar
The full article is available to subscribers Subscriber Login   

The FDA has approved infliximab-dyyb (Inflectra – Pfizer; marketed as Remsima in some countries), as a biosimilar of the TNF inhibitor infliximab (Remicade). Infliximab-dyyb was approved in the European Union (EU) in 2013 and in Canada in 2014. It is the second biosimilar to be approved by the FDA. Filgastrim-sndz (Zarxio), a recombinant human granulocyte colony-stimulating factor, was the first.1

BIOSIMILARS — US law defines a biosimilar as a biologic product that is highly similar to an approved biologic product (reference product) with no clinically meaningful differences in safety, purity, or potency; minor differences in clinically inactive components are allowed. An approved biosimilar product must have the same mechanism of action, route of administration, dosage form, and strength as the reference product.

Bioanalytical ... more      

The Medical Letter is a subscriber-funded nonprofit organization that publishes critical appraisals of new prescription drugs and comparative reviews of drugs for common diseases.

Would you like to read the rest of this article?  Gain access below.

Subscribe
Subscriptions to The Medical Letter on Drugs and Therapeutics include:
  • Print version published and mailed biweekly (26 issues/year)
  • Immediate Online access to current issue and archives from 1988 to the present
  • Mobile access to our mobile site and free apps for iOS, Android and Kindle
  • FREE online per issue CME/CE
Free trial offer
3 Free Issues of The Medical Letter on Drugs and Therapeutics mailed to your home or office PLUS online access.
Try a Free Trial Subscription
Purchase this article:
Title: Inflectra - An Infliximab Biosimilar
Article code: 1513c
 Electronic, downloadable article - $25