Biosimilars

Drug Shortages and You: Who's At Risk, What's the Fix?

John Horton | Posted 05.09.2012

John Horton

Drug shortages are a complex problem with multiple causes, not least of all manufacturing issues that can affect the safety of injectable medicines like biologics.

Data Exclusivity: Getting the Balance Right

John Horton | Posted 07.19.2011

John Horton

What's the right length for data exclusivity? The current law says innovator drug makers have twelve years; in the European Union, it's ten; and the 2012 budget proposes seven. Who's right?

Are Unsafes Drugs An 'Acceptable Risk?' FDA Should Say 'No!'

John Horton | Posted 05.25.2011

John Horton

As a matter of common sense, the FDA's process for biosimilars shouldn't sacrifice patient safety.

The 2010 Elections, Reflections, Lessons and Taking Stock

James Love | Posted 05.25.2011

James Love

It's hard to develop a public narrative and a legislative record as a champion of the underdog when you spend so much time pandering to giant corporate interests.

The White House Deal with Big Pharma

James Love | Posted 05.25.2011

James Love

The White House has abandoned any real effort to control costs in the pharma sector and Democrats have taken this hands-off approach as a green light to side with Big Pharma.

Eshoo and Barton Team Up to Block Generic Biologic Medicines

James Love | Posted 05.25.2011

James Love

The Eshoo/Barton amendment, which has the support of many newly pro-PhRMA democrats, will extend the period of monopolies for biologic medicines.

Howard Dean Claims He Is "Actually Not a Shill For the BIO." Then Stop Acting Like One

James Love | Posted 05.25.2011

James Love

I have always liked Howard Dean, but nothing excuses what he is doing now.

Howard Dean -- Now a Shill for BIO

James Love | Posted 05.25.2011

James Love

What exactly would it take to make Howard Dean a lobbyist? A special badge from the Wizard of Oz?

Joe Trippi Admits He Works for BIO, While He Plugs BIO Bill in HuffPo

James Love | Posted 05.25.2011

James Love

Trippi posted the lame assertion that "I have never been paid by anyone to post or blog anything by anyone." Well, what is BIO paying Joe to do?

Key Democrats Back BIO Industry Against Consumers to Delay Generic Medicines (Biosimilars)

James Love | Posted 05.25.2011

James Love

Unlike for pharmaceutical drugs, there is no easy way to get FDA approval for a generic biologic product. Congress is considering an FDA reform to fix this, but it is being derailed by the BIO.