Protect The Promise of ‘Biosimilar’ Drugs

Published June 22, 2009

Congress is exploring legislation that would create a new drug-approval process in the Food and Drug Administration for what are called “biosimilars,” drugs marketed after the patent has expired on an original biologic drug, such as insulin. Due to the complexity of genetically engineered drugs, biosimilars are similar but not identical to the originator drug. This means the approval process for conventional generic drugs isn’t appropriate for biosimilars.

Bills introduced by Rep. Henry Waxman (D-CA) (H.R. 1427) and Rep. Anna Eshoo (D-CA) (H.R. 1548) would create two very different processes for regulating biosimilars. In a new policy brief from The Heartland Institute, Dr. Richard Dolinar, a practicing endocrinologist in Phoenix, Arizona, proposes six principles that ought to guide the creation and implementation of a biosimilars approval process:

* Patient safety is paramount.

* Because these drugs are not identical to the original innovator drug, they are not to be called “generics” but instead are termed biosimilar or follow-on biologics.

* Both clinical and non-clinical testing of biosimilars is required in order to identify potential differences in clinical efficacy, unanticipated immunogenicity, and other adverse events.

* Post-marketing studies must be required of all follow-on biologics.

* Transparency and appropriate naming conventions must be used in order to easily distinguish follow-on biologics from originator drugs.

* Similar biologic products must be prohibited from being designated as interchangeable with (i.e., substitutes for) originator drugs.

Dr. Dolinar finds the Eshoo bill (H.R. 1548) more closely conforms to these principles than does the Waxman bill (H.R. 1427), and he explains why in his policy study at this site:

If you would like a hard copy of the policy study, or if you would like to speak to Dr. Dolinar, please contact Dan Miller, publisher, or Tammy Nash, media specialist, at The Heartland Institute, at (312) 377-4000 or [email protected] or [email protected].