Tags » INTERCHANGEABILITY

Methodist - A Movement

This week in the Church of England Synod there will be a discussion relating to this document:

MISSION AND MINISTRY IN COVENANT. It provides some detail in how the Church of England and the Methodist Church may be allowed to grow closer in unity in the years ahead. 900 more words

Redesign by Reimagination: NOAH & MR. Porter Construct Style to Surround the Suit

For quite some time, a suit has been associated with momentous occasions, elegant galas or conservative formality. NOAH and Mr. Porter are determined to dispel these connotations with their sophisticated-casual capsule of tailoring, rugby shirts, hoodies and tees. 130 more words

Sneaker Static

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 As mentioned in yesterday’s blog post, the Food and Drug Administration (FDA) draft guidance… 543 more words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