• by: |
  • 02/27/2015

The FDA has decided to postpone the March 17th meeting of the Arthritis Advisory Committee. The adcomm was supposed to discuss Celltrion’s infliximab biosimilar application. The Pink Sheet proclaimed this a “Biosimilar Bummer.”

What does the cancellation mean? Lots of potential tea leaves to read and no shortage of regulatory mediums. Bottom line – not a good thing for Celltrion. As to why, one thing to consider is the recent revelation that Hospira’s EMA-approved infliximab biosimilar (Inflectra) has shown some significant clinical differences from innovator and reference product Remicade.

For more on this issue see, “Interchangeability: When Irish Eyes Aren’t Smiling.”

A bummer for Celltrion to be sure, but the lesson to be learned is that the filgrastim adcomm, viewed by many as a FDA love-fest should not be viewed as a broader predictive regulatory response to every biosimilar application. Many saw it as such because they wanted it to be true.

(Infliximib is considerably more difficult to characterize than filgrastim – and characterization data was very important at the filgrastim adcomm.)

Bummer? Not if you understand that the decision tree for biosimilars is quite different from the Hatch-Waxman pathway. And that for the foreseeable future, each biosimilar application is going to be an important learning experience for FDA reviewers and senior division staff.

Repeat after me – there are no such things as generic biologics.

But it’s human nature to believe what you want to be true. No doubt those who are disappointed out will “blame the FDA.” A “bummer” is in the eyes of the beholder.

As Oscar Wilde said, “The truth is rarely pure and never simple.”

On a related note, yesterday I was honored to share my thoughts on the issue of biosimilar naming at the World Congress on Biosimilars Market Access. An important part of the discussion focused on the fact that biosimilar approvals are based on similarity – but in the real world success will be measured by patient outcomes. Real world data capture will be crucial to understanding the true clinical impact of biosimilars and for 21st century pharmacovigilance – which is why differential nomenclature is so important

Focusing on issues such as price and market share are important. But minus a concentrated strategy to measure patient outcomes and address pharmacovigilance issues as they arise -- it’s putting profits before patients.

And that’s not the spirit of the Biologics Price Competition and Innovation Act.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
Better Health
Biotech Blog
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog