Hospira CEO and Chairman Christopher Begley urged lawmakers yesterday to pass legislation enabling the FDA to create an abbreviated regulatory pathway for "safe, pure and effective biogenerics." In a keynote address at the Generic Pharmaceutical Association's (GPhA) Annual Policy Conference, Begley explained that the continual lack of an approval process is a critical policy issue.
What I found interesting was the tact Begley used to try and convince people that these biogenerics need to be fast-tracked - these biosimilars will save the American people money. According to the press release, "Begley underscored the generic industry's eagerness and readiness to bring additional financial relief to the American people in the form of safe, effective, quality-driven biogenerics."
Something sounds fishy to me. The reason they want to make these biosimilars is to save people money - sure. I have seen reports stating that these drugs are not going to be that much cheaper for Joe Consumer. Begley did not provide any specifics to the pricing of his six biogenerics in the pipeline compared to the current costs of the non-generic biologics. He just railed on the current costs. "When life-saving drugs are not affordable -- regardless of their safety and efficacy -- they are irrelevant," Begley said. What about 14 generic drugs doing the same thing - is that irrelevant? That is exactly what is happening for the drug Coreg (read the story). This is not a biologic drug but nonetheless.
Begley also drew a comparison between these same issues back in the "˜80s regarding the idea of approving traditional or small-molecule generic pharmaceuticals. "Safety and savings were questioned, and the specter of stifled innovation was raised. None of these fears were realized."
It might have taken 20 years, but the pharma pipelines are getting pretty bare. This might not be the direct result of generic competition but I'm sure it is a contributing factor. Besides the fact that pharma companies are spending a lot of time reformulating old drugs to retain patents.
I'm all for saving money. Somebody I know is taking these biologics and luckily she has very good insurance that is picking up the tab.
But, is fast-tracking biosimilars the answer? I might be wrong, but it seems to me that biogeneric manufacturers just want to get their share of the pie that much faster. Therefore, the "save more money" approach is interesting to say the least. The jury is still out.
BS
