By now, most of us are used to being offered, or just receiving, the generic version of common medications when we head to the pharmacy. These generics are identical to the name brand medications with expired patents, opening them up to duplication. Generics offer patients a cheaper way to get medication and are held up as a way to greatly reduce healthcare costs at the public health level.
But, there is another category of medication that’s become hugely important in the last 15 years. Biologics are medications that are derived through biological processes like purification of blood products or are produced by microorganisms genetically designed to be little drug factories like insulin. Many cancer drugs, vaccines and human growth hormone are all biologics.
These drugs are also much newer than traditional prescription drugs. The first biologics patents are set to expire next year. This means a new market for generic biologics, called biosimilars, is about to open up… and it will be huge.
Ed Silverman at the Wall Street Journal estimated the market for biosimilar drugs would hit $25 billion a year by 2020.
Because these medications are made through biology instead of chemistry like most prescription drugs, they are regulated by a different sector of the FDA. And the FDA has not yet decided on a key factor when it comes to biosimilar drugs. At issue is whether companies that make a biosimilar version of these name brand drugs can call them by the same clinical name Silverman explains:
When a biosimilar version of the Avastin cancer treatment becomes available, what should it be called? The chemical name is bevacizumab, and this is often used by physicians and pharmacists when they discuss the drug. But whether such generic nomenclatures should also become widely used commercial monikers is the subject of an ongoing controversy among drug makers and their major customers.
Obviously, the companies that make the original, name brand drugs want the biosimilars to call themselves something different. They argue that separate names would make it easier to report side effects to the FDA. According to Genetic Engineering and Biotechnology News, Europe uses a standardized naming system for biosimilars and has not had difficulty with reporting drug side effects.
Other groups, including companies that make generic drugs, have asked the FDA to make biosimillars fall under the same nonproprietary name, like generic prescription drugs do. They argue that doctors and pharmacists would have a difficult time if the name of a biologic and all its biosimilars have different names. That could impact patient safety, they say.
One complicating factor that’s important to note is that biosimilars are often not identical to their name brand counterparts, like prescription drugs are. Although the effective part of the drug is the same. That’s because the processes used to make the drugs are so much more complicated Mathew Herper at Forbes notes.
Herper reported on two case studies of biologic drugs that had biosimilar drugs enter the market. In both cases, the drop off in sales of the name brand wasn’t as clear cut as the market would predict because of brand loyalty and lack of knowledge of the biosimilar alternative:
So how quickly will sales erode? It will depend on the disease being treated and whether decisions are being made by physicians and patients or by hospital administrators.
Additional Resources:
- Biopharmaceutical industry consolidation diminishes future drug discovery, John LaMattina, Forbes
- FDA action against 23andMe reveals importance of communication in regulatory process, Jeremy Summers, Genetic Literacy Project
