What is the generic version of Enbrel? An overview of biosimilars

October 9, 2025 •

2 min read

Enbrel is a biologic drug, which means it does not have a traditional generic version, but instead has biosimilars. As of September 2025, no biosimilars for Enbrel are available on the market in the U.S. due to patent decisions, though some have received FDA approval. Patients asking "What is the generic version of Enbrel?" must understand this key distinction to navigate their treatment options and manage costs.

Quick Summary

Enbrel (etanercept) is a biologic, not a chemical drug, and therefore has biosimilars rather than a generic version. Two biosimilars have received FDA approval, but neither is currently available on the market in the U.S. due to ongoing patent litigation. Patients should talk to their doctor about alternative treatments.

Key Points

No True Generic: Enbrel is a biologic, not a chemical drug, so it does not have a generic version in the traditional sense.
Biosimilars Exist, but are Unavailable: Two FDA-approved biosimilars, Erelzi (etanercept-szzs) and Eticovo (etanercept-ykro), exist but are not yet on the U.S. market.
Patent Litigation Delays Market Entry: Legal battles over Enbrel's patents have prevented the launch of its biosimilars, with market entry not expected until around 2029.
Generic vs. Biosimilar Distinction: Generic drugs are exact chemical copies, while biosimilars are "highly similar" but not identical to their biologic reference product due to manufacturing complexity.
Active Ingredient is Etanercept: The generic name for Enbrel's active ingredient is etanercept, a TNF blocker that treats inflammatory autoimmune diseases.
Limited Interchangeability: Neither Erelzi nor Eticovo is designated as interchangeable, so automatic substitution by a pharmacist is not possible.

No Generic for Enbrel, Only Biosimilars

Enbrel is a "biologic" medication derived from living sources, unlike traditional chemical-based drugs. This complexity means it cannot be replicated as an identical generic drug. Instead, a similar product is called a "biosimilar". Biosimilars are highly similar to the original biologic and have no meaningful clinical differences in safety, purity, and potency.

The Generic Name: Etanercept

The active ingredient in Enbrel is etanercept, which is its generic name. However, a pharmacist cannot automatically substitute another etanercept product for Enbrel unless it is specifically prescribed or is an FDA-designated "interchangeable" biosimilar.

FDA-Approved Biosimilars: Erelzi and Eticovo

Two biosimilars for Enbrel have been approved by the FDA but are not yet available in the U.S. market:

Erelzi (etanercept-szzs): Approved in August 2016 for conditions like rheumatoid arthritis and plaque psoriasis.
Eticovo (etanercept-ykro): Approved in April 2019 for the same indications as Erelzi.

The FDA requires a four-letter suffix for biosimilar names to distinguish them. Neither Erelzi nor Eticovo has the interchangeable designation.

Why Are Enbrel Biosimilars Unavailable?

Market availability of Enbrel biosimilars has been delayed by patent litigation. The manufacturer's patents are currently protected, preventing competitors from launching their approved biosimilars until at least 2029.

Understanding Biologics and Generic Drugs

The differences between generic drugs and biosimilars are crucial for patients. The table below outlines these distinctions:


Feature	Generic Drugs	Biosimilars
Reference Product	Small-molecule chemical drug	Complex biologic drug (like Enbrel)
Composition	Identical chemical structure	"Highly similar" but not identical
Manufacturing	Standardized chemical synthesis	Complex process using living cells
FDA Approval Process	Abbreviated New Drug Application (ANDA)	Abbreviated Biologics License Application (BLA)
Automatic Substitution	Often permissible by pharmacists	Only permissible with an "interchangeable" FDA designation
Market Availability	Enters when patents expire	Delayed by patents and regulatory hurdles

How Does Etanercept (Enbrel) Work?

Etanercept is a TNF blocker that reduces inflammation in autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis. It works by blocking TNF, a protein that promotes inflammation.

Conclusion

While there is no generic version of Enbrel, the active ingredient is etanercept, and two biosimilars are FDA-approved though not yet available in the U.S. due to legal challenges. Patients seeking to manage costs should discuss alternative treatments and financial assistance programs with their healthcare provider. The future availability of biosimilars is expected to increase competition and potentially lower prices.

Frequently Asked Questions

Enbrel is a biologic medication, made from living organisms, which means it is too complex to have an exact, identical generic version like traditional chemical drugs. Instead, it has highly similar versions called biosimilars.

The generic name for Enbrel's active ingredient is etanercept.

Yes, two biosimilars for Enbrel, Erelzi (etanercept-szzs) and Eticovo (etanercept-ykro), have been approved by the FDA.

Due to ongoing patent litigation and market exclusivity for Enbrel, the FDA-approved biosimilars have not yet been launched in the U.S. and are not expected to be available until at least 2029.

A generic drug is an identical chemical copy of a brand-name drug. A biosimilar is a highly similar, but not identical, version of a biologic drug, with no meaningful clinical differences.

No. For a pharmacist to automatically substitute a biosimilar, it must have an "interchangeable" designation from the FDA. Neither Erelzi nor Eticovo has this designation.

You can investigate patient assistance programs offered by the manufacturer (Amgen Safety Net Foundation), look into discount programs, use a manufacturer copay card, or discuss alternative, potentially more affordable, treatments with your healthcare provider.