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Who is the manufacturer of etanercept?

The growth of this market is influenced by the rising prevalence of autoimmune disorders such as psoriasis, spondylitis, rheumatoid arthritis.

In addition, the growing availability of biosimilars, heightened awareness of biologic therapies, and reimbursement structures in developed markets are all accelerating uptake of treatments. Moreover, increasing healthcare infrastructure in emerging economies, continued guidance from clinical trials looking to expand indications, and improvements in protein engineering are all increasing the size of the market.

List of the manufacturer of etanercept

1. Sandoz (Novartis division)

Sandoz markets the first FDA approved etanercept biosimilar, Erelzi® (GP2015), which was launched in 2016 in the EU and in 2019 in the US. It represents a major step in expanding biosimilar access.

2. Hanwha Chemical

Hanwha Chemical, via HD203, has completed Phase I clinical trials on its etanercept biosimilar candidate 

3. Samsung Bioepis (Joint venture of Samsung Biologics & Biogen)

Samsung Bioepis (through Samsung Biologics) developed the biosimilars Benepali® (EU) and Eticovo® (US), based on the etanercept molecule. It has a strong presence in both regions. 

4. Amgen Inc.

Amgen originally developed Enbrel (etanercept), the best-known TNF inhibitor for autoimmune disorders like rheumatoid arthritis. Enbrel remains a blockbuster biologic, generating approximately US $3.3 billion in US sales in 2024.

5. LG Life Sciences (LG Chem subsidiary)

LG Life Sciences has a biosimilar candidate LBEC0101 that targets etanercept. It has been submitted for regulatory review in markets including Japan. 

6. mAbxience (a Fresenius Kabi company)

mAbxience developed an etanercept biosimilar in partnership with Intas for global distribution in over 150 countries, including the EU and US.

7. Intas Pharmaceuticals Ltd.

Intas licensed mAbxience’s etanercept biosimilar for distribution in over 150 countries, bolstering its position in global biosimilar markets.

8. Cipla Ltd.

Cipla markets Etacept® in India, the country's first etanercept biosimilar, co manufactured with China based Shanghai CP Guojian. It offers a more affordable option with ~30% lower pricing than Enbrel. 

9. Celltrion, Inc.

While Celltrion is not primarily known for etanercept, it is a major biosimilar manufacturer (infliximab, trastuzumab) and is emerging as a broader biologics player capable of entering etanercept biosimilar space 

10. Avesthagen (Avgen Pharma)

Avgen Pharma is developing Aventâ„¢, a preclinical-stage etanercept biosimilar. Avent has completed preclinical toxicity and efficacy studies and is advancing toward clinical trials.

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