LegitScript’s President, a HuffingtonPost.com contributing blogger, published a blog yesterday entitled “Biologics: Are Unsafe Drugs an ‘Acceptable Risk?’ FDA Should Say No”. The topic is biologics, which are drugs made from living organisms. Examples include Abraxane, a chemical wrapped in human proteins, used as a treatment for breast cancer. (As to the title of this blog, studies are continuing on products such as Desmoteplase, made from vampire bat saliva, for stroke victims.)
To date, most rogue Internet pharmacy activity has been focused on non-biologic drugs, such as Viagra, Propecia or tramadol. But as biologics emerge as increasingly effective and safe medicines, whether rogue Internet drug outlets will attempt to market unapproved versions of these drugs remain to be seen.
One of the key differences between non-biologic drugs and biologics is that technically, there isn’t really any such thing as a “generic biologic.” As explained in the HuffingtonPost blog:
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.
Unlike typical chemical prescription drugs, it isn’t possible to create a truly identical “generic” version of a biologic.
…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.
There are two important principles at stake that must be balanced out. One, of course, is patient access to needed medications. If biosimilars can be marketed more cheaply, thus expanding access, that can save lives. But on the other hand, if safety standards are relaxed so much that some “biosimilar” drugs are held to lesser standards, that increases the likelihood that some “biosimilars” may end up being less safe and/or effective, which can cost lives.
This is likely to be one of the biggest intellectual battlefields on the healthcare front in years to come. On the Internet front, we’ll be watching to see whether as biosimilars become approved and more widely disseminated there is a surge in substandard biologic knock-offs sold over the Internet.