Dems to Deal with Biotech Generics?

The Hill.com:

Senior Democratic lawmakers are close to introducing legislation to create a pathway for the approval of generic biological drugs in the hopes that the cheaper medicines will create billions of dollars in budget savings, which could be used to offset some of the cost of expanding federal health programs.

Here's some background on this.

So what steps will generic drug makers need to take in order to market biologic therapies, which fall in a different category? Biotech companies argue that protein-based medicines are more complicated than chemical entities: They are larger, not as well characterized, and are manufactured by cultured cells under closely guarded proprietary processes.

Insulin and human growth hormone may be simple, easily characterized proteins, but most biotech therapeutics are considerably more complex. For instance, it's well known that a vial of a protein-based therapy such as Epogen actually contains a heterogeneous mixture of recombinant proteins, with different sugar groups or glycoforms, for instance – making it all the more difficult to duplicate.

According to this logic, espoused by biotech firms and the Biotechnology Industry Organization (BIO), generic manufacturers would have to test their products in clinical trials anyway, which would probably erode the price differential between a branded drug and a generic one.

What are they proposing? Fund the FDA more? Allow biologics to be approved without trials? The article doesn't really say. From the Hill.com article:

The Biotechnology Industry Organization (BIO) rejected PCMA's analysis, in part by arguing that PCMA underestimates the cost of manufacturing biologic drugs, especially for those companies that have never done it before.

The Food and Drug Administration (FDA) long has had a process in place to approve of generic versions of drugs made of chemical compounds, of which exact copies can be made.

This is clearly not true. This IS true, however... ahem To date there is one biogeneric which was the exception according to the FDA:

The FDA, however, made it quite clear that Omnitrope was not therapeutically equivalent to Genotropin (in the manner of a generic version of a chemically-based drug), and that its decision to approve the product does not "establish a pathway" for the approval of other follow-on biologics. Moreover, the FDA stated that Congress must enact new legislation before it will be able to approve almost any other so-called copies of recombinant biotech therapies.

Err.

"There's a great deal of savings that can be achieved," Waxman said. Although he would not name a specific amount or range of savings in dollars, he said, "There are some pretty dramatic figures." New York Democratic Sens. Charles Schumer and Hillary Rodham Clinton will introduce a companion to his bill, Waxman said.

My guess is the legislature is being told by generics lobbyists that the outrageous cost of biotech drugs can potentially be brought down to the generic pharmaceuticals range. Unlikely as of now (nonetheless, be careful what you wish for).

So just what will this bill do? If it is to work, it needs to increase funding to the FDA and provide authority to the FDA to approve generic biologics. To do the latter, it must make the inevitable trade off.

- Dare you skip clinical trials for biologic generics you need to deal with the obvious consumer backlash/lawsuits/cost increase when it's discovered they double the chance of heart attack, etc, but never underwent clinical trials!

- Or, the cost of generics is nearly as expensive after they fund clinical trials and FDA approval.

We shall see...