What is a Biosimilar?

The FDA defines biosimilars as “a type of biological product that is licensed (approved) by the FDA because they are highly similar to an already FDA-approved biological product, known as the biological reference product (reference product) and have been shown to have no clinically meaningful differences from the reference product.” For more information, check out the FDA Biosimilar Information

Biosimilars vs Generics

Biosimilars are not generic drugs.  Generic drugs have the same active ingredient and even share the same dosage form, strength and route of administration as the brand name drug.  Biosimilars, on the other hand, are very similar to the brand name drug but do have slight differences.  However, in terms of safety, purity and potency, there is no clinically meaningful difference between a biosimilar and the reference product.

How are Biosimilars Priced?

Biosimilars average wholesale price (AWP) and wholesale acquisition cost (WAC) are 15% lower than their similar reference products.  From a reimbursement perspective, both Zarxio and Inflectra are priced similarly to single-source generics.  This makes sense because current levels of competition in the market place are low.  When additional manufacturers enter the market the prices should continue to fall.  With that said, commoditization will be a slower process than with typical generic drugs because of the high costs and complexity associated with manufacturing biological products.

How to Identify Biosimilars

1. FDA Purple Book
   • The FDA Purple Book provides a list of biological products licensed by the FDA and the date the biological product was licensed.  Furthermore, it includes whether the product has been licensed as a biosimilar or an interchangeable product.
2. Medi-Span Substitutions Group File
   • A supplemental file available at no cost to organizations with a license to either the Medi-Span Master Drug Database (MDDB) or the Medi-Span Electronic Drug File (MED-File).  The content is based upon the FDA’s Purple Book.

List of FDA Approved Biosimilars (As of 1/9/17)

The following table is a list of FDA approved biosimilars along with their NDC and the reference product.