It’s been more than 4 years since the first biosimilar Zarxio was approved in the U.S. Zarxio, developed by Sandoz, a Novartis division, is a biosimilar version of Amgen Inc.’s (AMGN) Neupogen, and it received the regulatory nod in the U.S. in March 2015.
Biosimilars are biological products, i.e., medicines made from living organisms, that are similar to already-approved biological drugs, referred to as reference biologic medicines.
Although biosimilars and generics are launched only after the patents on the reference biologics/brand drug expire, and both are less expensive, biosimilars shouldn’t be confused with generics. While biosimilars are made from living organisms, generic medicines are chemically synthesized. A biosimilar is only “highly similar” to the reference biologic while generics are identical or bioequivalent to a brand drug.
In the U.S., as of this writing, only 25 biosimilars have been approved by the FDA, while Europe has approved over 60 biosimilars.
Biosimilars have been approved for Avastin, Enbrel, Epogen, Herceptin, Humira, Neulasta, Neupogen, Remicade, and Rituxan.
Let’s take a look at the FDA approved biosimilars, starting with the latest.
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