Hope S. Rugo, MD: The whole concept of generics and having a patent run out on an agent is, of course, old. Once a patent runs out and the company no longer owns single rights to a drug, any company anywhere could make the same chemical. They can show that it’s reasonably pure and doesn’t cause problems in animals and can put it on a shelf and market it. That can happen all over the world, and it’s a huge market.
But when biologics became a part of successful treatment for rheumatologic diseases and cancer, the whole concept that came about was, how could we ever have a generic for a biologic? It’s not a simple chemical, so you could never do anything that was a generic. That’s where the whole concept of biosimilars came into play.
The Biologics Price Competition and Innovation Act tried to address the idea that we have a lot of innovative products. The patent life will eventually expire on these drugs, although that’s a whole other area of controversy—in regard to what defines the patent’s life. When that patent life runs out, how will there ever be any competition unless people have a path to develop agents that are biosimilar? In other words, similar to a biologic agent.
That would result in competition and price lowering and more accessibility throughout the world. This is really important. And so, that was actually developed as an act and was put into law—that you could have these biologic similar agents and have competitive pricing, etc. A lot of organizations, including the United States FDA, European Medicines Agency, and World Health Organization, have a great interest in these biosimilar products, because competition with pricing is really important in order to expand the accessibility of potentially lifesaving agents around the world. That’s what really led to the act and sort of paved the way for the beginning of the field of biosimilars, now some time ago.
Cornelius F. Waller, MD: Each extra substance being developed is being issued a so-called INN [international nonproprietary name] by the World Health Organization. In 2015, the FDA suggested a naming procedure where this INN—for example, for filgrastim—would be followed by 4 lowercase letters, which could be introduced or suggested by the manufacturer. Then the FDA would choose, out of several suggestions, the naming for this particular compound.
This is an important issue, with regard to safety of the patients and pharmacovigilance. If a patient experiences adverse effects during the course of treatment, it is possible to know what kind of compound this particular patient has received. Physicians have to monitor the therapy and then, if such adverse events occur, report them to regulatory agencies. This makes it possible to see, after marketing of the product, whether there are any safety issues. In this regard, this unique naming helps a lot.
For example, if filgrastim was produced by Sandoz, it was named filgrastim-sndz. I suppose this is because of the producer of the drug, but there’s not necessarily a meaning out of these 4 letters.