When will praluent go generic?

Praluent (evolocumab) is a biologic drug, so the “generic” path is actually a biosimilar path. The first biosimilar can only appear after all of the original product’s patents and regulatory exclusivities have expired and the biosimilar has been approved by the FDA.

What we know so far

Bottom line

• No generic (biosimilar) has been approved as of now.
• The earliest a biosimilar could realistically appear is around 2027–2028, once all patents expire and the FDA has cleared the product.
• Even then, it may take a year or more for a manufacturer to file and for the FDA to review and approve it.

Because biologic generics (biosimilars) are still relatively new and each product’s pathway can differ, the exact timing is uncertain. If cost is a concern, it’s a good idea to talk with your prescriber or pharmacist about:

• Any current patient‑assistance programs for Praluent,
• Potential use of a similar PCSK9 inhibitor that may already be available, or
• Whether a biosimilar has entered the market recently (you can check the FDA’s list of approved biosimilars).

Feel free to reach out if you’d like help tracking any updates or exploring alternative therapies.