A biosimilar is a biologic medicine that has been certified by regulatory bodies such as the US Food and Drug Administration to be highly similar to an already approved biologic known as the reference product. A variety of tests, both in the lab and in clinical research, confirm this similarity.^1,2 Biosimilars must meet the FDA’s strict approval criteria.

Biosimilars are used for treating many illnesses, including cancer. They are made with the same types of natural sources as the original or reference biologic they were compared to (in this case, NEULASTA^® (pegfilgrastim)) and provide similar treatment benefits. This means patients and healthcare professionals will be able to rely upon the safety and effectiveness of the biosimilar, just as they would the original product (also known as the "Reference Product").