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On January 10, the Food and Drug Administration (FDA) released its long-awaited draft guidance on the interchangeability standard for biosimilar manufacturing.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

Some of the Conflicting Concepts Around Interchangeability

At the Biosimilar Multistakeholder Summit, a closed meeting of 17 executives that was held November 30–December 2 in San Diego, organized by StrategiX, a number of important issues were raised regarding the daunting question of interchangeability. 398 more words

Largest French Hospital System Decides on Infliximab Substitution

Although Celltrion and Pfizer’s Inflectra® was not approved as an interchangeable product to Remicade®, this will generally not matter to US payers when deciding the coverage of the product in patients who have not had anti-TNF treatment in the past. 348 more words