Thursday, June 19, 2014

The Naming of Biosimilars

At the cutting edge of all our progress in personalized medicine is the development of  biologics. These are medicines that are manufactured or extracted from biological rather than chemical sources. Biologic is used to describe the structure in the original or innovator medicine that was developed and biosimilar is used to describe the medicines that are developed that are similar to the original biologic.

Biologics and biosimilars hold great promise for the next generation of personalized medicine but only if we are able to track their effect on individuals. These are powerful new medicines. Consumers should know what they are getting and healthcare providers should be able to track the effects of what their patients get. While it is good to have these new medicines it is essential to be able to track them once they are given to patients.

To make this point we sent a letter to the FDA Commissioner today that was signed by over twenty-one partner organizations reaffirming the importance of giving each product a unique name . The value of what we know about the impact of these products would be substantially diminished if we are unable to track the products once they are approved. 

It is good science, good practice, and common sense that each product should have s prefix or suffix added to its name so it can be tracked. All that is needed is a distinguishable name. That should be an easy call for the FDA to make and one that responsible companies should applaud.

Tuesday, June 3, 2014

Sugar Sweetened Beverages--- Less is More than Enough

And so it continues...The Alliance is the lead signator supporting the NYC Health Department. Tomorrow (June 4) the Court of Appeals for the State of New York will hear oral arguments N.Y. Statewide Coalition of Hisp. Chambers of Comm. v. N.Y.C. Dep’t of Health and Mental Hygiene.  You can watch the debate live—oral arguments will be streamed from the Court of Appeals’ website starting at 2 p.m. E.T. Court’s summary of the case is available here: