Will Approval of an Interchangeable Biosimilar Mean that Others Are Inferior?

In terms of the biosimilar market and utilization, the US has been at least one full decade behind Europe in every respect but one. Yes, we have the EU beat in a game they avoided playing: The interchangeability gambit. 448 more words

Interchangeable Biologics: FDA’s Requirements for Approval

By Loan Pham and Vien Lai

Being “biosimilar” does not equal being “interchangeable.” As mentioned in yesterday’s blog post, the Food and Drug Administration (FDA) draft guidance… 543 more words

Current Perspectives

Biosimilar and Interchangeable Biologics: What Is What?

By Loan Pham and Vien Lai

For decades, everybody has become familiar with many brand-name and generic chemically synthesized drugs that are small molecule drug products, such as amoxicillin, Lipitor, and Crestor. 567 more words

Current Perspectives

What Happens When Switching Among Biosimilars?

Late last year, I wrote about a biosimilar challenge that could be on the horizon. With the approval of the second infliximab biosimilar (infliximab-abda by Samsung Bioepis), that horizon is a lot closer. 396 more words

Clinical Pharmacology Studies to Support a Demonstration of Biosimilarity and Interchangeability

By Peijuan (Penny) Zhu, Shrinivas Savale, and Gillian Woollett

Clinical pharmacology studies are critical in demonstrating biosimilarity because they provide clinical pharmacokinetic/pharmacodynamic (PK/PD) similarity data to confirm biosimilarity. 407 more words

AAPS Newsmagazine

Interchangeability Guidance Released, FDA to Require Switching Studies

On January 10, the Food and Drug Administration (FDA) released its long-awaited draft guidance on the interchangeability standard for biosimilar manufacturing.

It’s been quite a while since we have been able to discuss progress on interchangeability, so as a reminder, the practical differentiator between a product designated as biosimilar versus interchangeable is that the latter “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.” 182 more words