2016 was a momentous year for the biosimilar market as the first of these drugs were approved for use in the US. Of the four biosimilars introduced, it’s notable that three of them are RA medications. Inflectra, a Remicade biosimilar, was approved in April; Erelzi, an Enbrel biosimilar was approved in August; and Amjevita, a Humira biosimilar, was approved in September. The fourth biosimilar, Zarxio, is prescribed for cancer patients.
It’s important to understand that these drugs are not identical copies of the original like a manufactured generic drug is. Most medications are chemical compounds that are created through a specific process. Aspirin is a great example and the aspirin compound created in a high school chemistry class is identical in structure to the aspirin you can buy off the shelf at your local store.
Biologic drugs, however, are animal-based proteins that are grown in a lab. This applies to both the original biologic as well as the “similar” drug. While similar, just as two fingerprints are similar, the biosimilar can never be an exact match to the original. To illustrate the complexity, if aspirin (which has about 20 molecules) is a one-room log cabin, then a biologic is the Empire State Building.
Read the full story here: https://rheumatoidarthritis.net/living/biosimilars-not-generics/