Basics of Biosimilars

Drugs vs. Biologics: What’s the Difference

If you ask a layperson about biosimilars, you are likely to hear comparisons to generic drugs, and that would not be completely wrong. Biosimilar products are not drugs and they are not generic, in the sense that they’re not identical to the reference product. They are similar in that they’re intended to offer potentially lower prices when made available for sale.

Drugs are made from chemicals and are smaller molecules compared to biologics, which are made from living organisms and are larger molecules. Oh, and biologics tend to be (much) more expensive than drugs.

Regulatory Landscape

Prior to 1984, generic drugs were required to undergo the same level of scrutiny as the drugs they were intended to substitute. In 1984, Congress passed the Drug Price Competition and Patent Term Restoration Act, more commonly known as the Hatch Waxman Act. As a result, generic drug approval was simplified, and the generic sponsor was required to demonstrate only that the generic version was equivalent to the reference (branded) drug. Branded drug companies received consolation through an extension of their market exclusivity equivalent to approval delays for new drugs from the FDA. Read more >