I know I complain on a fairly regular basis about the cost of biologics (like Enbrel, which I am currently on, and Remicade, which I used to be on). However, I have to admit that I haven't spent a lot of time looking into the safety issues associated with biologics. To be perfectly honest, this is mostly because it freaks me out, and my desire to feel better has been at a point where I'm willing to trust my doctors about the issue.
In any event, APL found this interesting article about biologics in the Huffington Post. I thought the article did a really good job of explaining how biologics are different from other types of prescription drugs and highlighting some of the safety issues involved with attempts to reduce costs:
Biologics are different from typical chemical prescription drugs in important ways. Generic drug companies can make virtually identical copies of non-biologics like Lipitor and Prozac. Once the original drug maker's exclusivity period expires, generic drug makers can apply for FDA approval, piggybacking on the original company's safety and effectiveness studies, rather than spend millions to develop their own. As a result, the company can offer generic drugs at a fraction of the original cost, allowing patients to save dramatically for medicines of equivalent safety and efficacy.Yet biologics are different: just as no two living things are precisely identical, it isn't possible to create a truly identical "generic" version of a biologic drug. At most, a second-generation drug maker can create a version that is similar to, but not the same as the original -- thus the term "biosimilar." But depending on how similar it is, a "biosimilar" may or may not be equally as safe and effective as the original biologic.
The article then goes on to criticize pharmaceutical companies that are arguing for less stringent safety standards in the FDA approval of "biosimilar" drugs, with the justification that it will save on costs. I have to say that I tend to agree with the author. While I'm not thrilled about the high cost I have to pay to get the benefits of these drugs, I'm already a little bit wary about their safety and efficacy. And, as much as I want to feel better, I don't think I'm willing to risk my body any more to save a few bucks.
Although I have to admit, the idea of using vampire bat saliva is pretty cool....