Generic biologics

Biologic drugs are made by culturing specially engineered organisms, and no approval path for generic versions exists in the U.S.

The producers of these complex generics -- often called biosimilars -- will likely face tough regulatory scrutiny, if a law allowing generic versions of biologics is drafted .

Furthermore, many prominent biotech drugs will remain under patent protection for a number of years.

Under current law, generic drug makers can receive approval of copycat small-molecule drugs,
like cholesterol-fighting statins, after their five years of exclusivity expire.

In applying for approval, small-molecule generics must show they have the same active ingredient and the same action as the brand-name version -- which allows them to rely on the original clinical trial results and avoid having to pay for new trials.

But biologics are large proteins that are sometimes thousands of times bigger than small molecule drugs. Their manufacturing makes them sensitive to minor changes in the process, potentially altering their complicated structures and even how they work in the body.

If generic biologics have their own brands, then pharmacists won't be able to substitute them for the original, which means that generic companies will be forced to market their version of the drugs to physicians. Small-molecule drugs typically see generic substitution as high as 90%, a level not expected with branded generic biologics.

Multiple barriers to entry to sell generic biologics will limit the number of likely participants.

Generic biologics will only be for a few players.