Clinical pharmacology studies are critical in demonstrating biosimilarity because they provide clinical pharmacokinetic/pharmacodynamic (PK/PD) similarity data to confirm biosimilarity. 407 more words
Tags » INTERCHANGEABILITY
On January 10, the Food and Drug Administration (FDA) released its long-awaited draft guidance on the interchangeability standard for biosimilar manufacturing.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
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