Biologics: A Good Thing

Biological products, or biologics, constitute a growing portion of the medical treatment market. In contrast to traditional drugs, which are identified compounds—including an increasing number of synthetic molecules—biologics are complex products the structures of which are not necessarily known. These products can include amino acids, recombinant DNA, tissue, and a variety of other vaguely weird-science [i.e., awesome] substances. You can read more about biologics here.

The Food and Drug Administration (FDA) though its Center for Biologics Evaluation and Research (CBER) regulates the approval of these substances for medical use under the Food, Drug, and Cosmetic Act. (Fun fact: the FD&C Act dates back to 1938, and is a direct descendent of the 1906 Food and Drugs Act, which was in part galvanized by the publication of The Jungle by Upton Sinclair. Moral of the story: sketchy meatpacking in the early 1900s still has an effect today. History lesson over; sorry.)

Anyway, as we all know, the pharmaceutical industry has issues with patents, and now biologics are becoming part of the issue. A variety of parties—many of whom I suspect work for the companies that produce brand-name biologics—have expressed concerns about generic biologics because if you can’t identify a compound precisely, you can’t necessarily make a generic version of it. But let’s be serious—with effective regulation and testing of these products, we can rest assured that the FDA isn’t going to randomly approve something that’s going to make you grow third ear. These “follow-on” biologics have the potential to increase access to the most cutting-edge treatments for a variety of conditions and save Americans billions of dollars.

And who is going to benefit from the increased affordability of biologics? You can watch this video to hear the perspective of this very attractive scientist who works for Insmed, who will tell you that biopharmaceutical companies are working on treatments for conditions including cancer and multiple sclerosis. But if you check out CBER, you will also see that there are a variety of biologics that even healthy people can use. My personal favorite is Gardasil, the vaccine against four types of human papillomavirus (HPV) which cost me way too much and needs to be available to everyone (well, right now every girl and woman, but I am looking forward to the day it gets the approval for use in men as well). Recombinant DNA makes this vaccine safer because it doesn’t depend on attenuated virus, so there’s no chance that the vaccine with give you HPV (as opposed to let’s say… smallpox).

In conclusion, biologics: a good thing. Increasing the opportunities for companies to produce low-cost, highly effective generic(ish) versions of off-patent biologics: an awesome thing. Because if the best treatment is so expensive that no one can afford it, then it isn’t a very good treatment at all.