Follow-on biologics (generics) legislation moves forward in Senate

Implications: A Senate committee has approved legislation that would create a pathway for biotech drugs to be sold as generics, despite key differences between traditional pharmaceuticals and biotech drugs.  There is one hint as to whether this bill will pass this year:

Analysis: If the bill that the Senate HELP committee passed is included in PADUFA, the bill that sets funding for a significant portion of FDA fundings, follow on generics will likely be permitted.  If it is not included in PADUFA, and is offered up as a stand-alone bill, it's chances for passage, this year at least, are greatly reduced.

The Senate bill would create a pathway for biotech drugs to be sold as generics, while requiring at least one clinical test of the generic, recognizing that re-creating a biotech drug is not as simple or exact as simply copying a chemical compound, as with traditional generics. FDA will have authority to waive the clinical test requirement.