Biosimilars – Information for Consumers

Many of today’s important medications are biological products. Biological products are made from living organisms. The material they are made from can come from many sources, including humans, animals and microorganisms such as bacteria or yeast. Biological products are manufactured through biotechnology, derived from natural sources or, in some cases, produced synthetically. Biological products are among the medications used to treat conditions such as rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, skin conditions such as psoriasis and various forms of cancer. Most biological products are more complex in structure and have larger molecules or mixtures of molecules than conventional drugs (also called small molecule drugs). Conventional drugs are made of pure chemical substances and their structures can be identified. Most biologics, however, are complex mixtures that are more difficult to identify or characterize. The FDA has approved a second biosimilar product—Inflectra (Infliximab-dyyb), a biosimilar to Remicade (infliximab)—and expects to approve other biosimilars in the future. The FDA approved Zarxio (filgrastim-sndz), a biosimilar to Neupogen (filgrastim), in March 2015.