Drugs prescription may cost a lot and it has always been an issue. However, now we can observe quite a big market of cheaper biopharmaceutical products called biosimilars. This market is constantly growing leading to more competition and choices for patients.
Biosimilars are terms used to describe officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Biosimilars can possibly decrease the price for patients by making price competition for products that previously had no or only few market competitors. The aim of FDA is to ensure that doctors have all relevant information needed for considering prescribing biosimilars if they are available.
As it has been mentioned before an FDA-approved biosimilar is highly similar to the original already approved by FDA biological product, so-called the “reference product.” Biosimilars and reference products do not differ in safety, effectiveness and purity patterns. Overall, biological products are very complex compounds which are often used to treat patients with severe and life-threatening diseases.
By now the FDA’s Center for Drug Evaluation and Research (CDER) has approved seven biosimilars. FDA’s directors say that just as more biosimilars are approved by FDA, they want doctors to be fully informed of what these drugs are, and how they can potentially help patients. That’s why FDA has recently launched a special educational campaign.
Before starting this campaign, they have made a research to find out what exactly health care providers want to know in this area. It turned out that most of all the doctors want to get the information regarding the information FDA reviewed and the aspects which FDA considered while making decisions to approve a new biosimilar. Based on these findings they have corrected the educational materials and the course content.