Behind closed doors a fight has ensued in the pharmaceutical industry between the makers of brand-name medications derived from living organisms—known as biologics—and those who to make and sell copies of those drugs. The fight is over drug protection. Companies like Amgen want state legislatures to require pharmacists to notify doctors (and sometimes patients) when they substitute generics for brand-name biologic drugs. The question is why? Money…. Manufacturers of copies fiercely opposed such a requirement, which they said would put them at a competitive disadvantage.
Biologic Copies Are Coming
Most believe it will be at least two years before any copies of biologics receive approval from the Food and Drug Administration (FDA). But the skirmishes in 18 states this year give a sense of the high stakes involved. Biologics already account for roughly a quarter of the $320 billion spent annually on medications in the U.S., according to IMS Health, and biologic medicines are expected to command ever larger portions of the prescription drug marketplace. Even the government is trying to get into the fight. The Affordable Care Act calls for an abbreviated approval process for the biologic copies, as a means to promote competition and reduce costs.
While the FDA will determine whether particular biosimilars are interchangeable with the originals, it will be up to the states to determine the exact policies regarding substitutions. Companies that make the copies say their products should be treated no differently than generic chemical drugs.
Trying to Copy a Complex Substance
There are big differences between copying chemical drugs and copying biologic drugs. Until the 1970s, virtually all manufactured medicines were derived from chemicals or chemical components. They are sometimes called “small molecule” drugs because they are composed of relatively few atoms and have stable, well-defined chemical structures. This makes it relatively easy to produce exact duplicates. Biologics, which are used to treat patients with cancer, blood irregularities, psoriasis, and auto-immune and neurological disorders, are the result of complicated biological manufacturing and testing processes. They have as many as 20,000 atoms, and they interact with the body in different ways from chemically-derived medicines. The patent on these types of drugs are usually on how its made and not so much what it is made of.
So it is virtually impossible to make exact copies, but you can make something very similar. Hence, the generic versions are often referred to as “biosimilars,” “bioequivalences” “biocomparables,” “me-too biologics” or “biobetters.” The expense and complexity of manufacturing biosimilars also means they won’t be as deeply discounted as generic chemical drugs, which generally cost 50 percent to 90 percent less than the originals. Biologic copies are expected to cost between 10 percent and 20 percent less than the originals.
Have you used Biologic medications?