Enbrel® – Etanercept Injection

Enbrel® – Etanercept Injection | U.S.-Manufactured Global Supply TNF-α Inhibitor

Product Overview

Enbrel® (etanercept) is a recombinant human TNF receptor fusion protein (TNF inhibitor) developed by Amgen Inc. and marketed globally in partnership with Pfizer. It is one of the first biologic agents approved for the treatment of several chronic autoimmune inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

The product offered here is manufactured in the United States by the originator company, and supplied through Amgen’s global pharmaceutical distribution chain. While packaging and labeling are adapted to comply with local regulatory and language requirements in each country, the formulation, strength, injection device, and manufacturing standards are identical to the U.S.-marketed version.

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Key Features & Advantages

• ✅ Original Brand by Amgen, U.S. Manufactured
  Produced under FDA and international cGMP standards; not a biosimilar.

• ✅ Proven TNF-α Inhibitor
  Over two decades of clinical use and long-term outcome data across multiple autoimmune indications.

• ✅ Identical to U.S. Product
  Only the external packaging and leaflet are localized; drug content and device are unchanged.

• ✅ Multiple Indications Approved Globally
  Approved in 100+ countries for adult and pediatric inflammatory conditions.

• ✅ Ready for International Supply
  Available to licensed medical institutions, importers, and distributors under global compliance frameworks.

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Product Specifications

• Product Name: Enbrel® (etanercept injection)

• Active Ingredient: Etanercept (recombinant human TNF receptor Fc fusion protein)

• Strength / Form: 25 mg or 50 mg prefilled syringe / SureClick® autoinjector / powder for reconstitution

• Route of Administration: Subcutaneous injection

• Manufacturer: Amgen Inc. (USA)

• Packaging: International version with localized labeling; formulation identical to U.S. version

• Storage: 2°C–8°C (refrigerated); do not freeze

• Shelf Life: Typically 24 months from manufacture

• Distribution Type: Original manufacturer biologic; not a biosimilar

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Mechanism of Action

Enbrel® works by binding to tumor necrosis factor-alpha (TNF-α), a pro-inflammatory cytokine involved in the pathogenesis of chronic autoimmune diseases. By acting as a decoy receptor, etanercept prevents TNF-α from activating its natural receptors on the cell surface, thereby suppressing systemic inflammation and halting disease progression.

This mechanism has proven effective in:

• Reducing joint damage and preserving function in RA and PsA

• Improving spinal mobility and pain control in ankylosing spondylitis

• Clearing psoriatic plaques in moderate-to-severe plaque psoriasis

Reference: NIH – Etanercept Mechanism & Review

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Indications (may vary by market)

• Rheumatoid Arthritis (RA) – adults

• Juvenile Idiopathic Arthritis (JIA) – children aged 2+

• Psoriatic Arthritis (PsA)

• Ankylosing Spondylitis (AS)

• Moderate-to-severe Plaque Psoriasis (PP)

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Compliance Statement

This product is manufactured in the United States by Amgen Inc., and distributed via the global supply chain for international use. The drug formulation, device, and quality standards are identical to the U.S.-market Enbrel®. Labeling and packaging may be adapted to local language and regulatory requirements. Importers, healthcare providers, and authorized distributors are responsible for ensuring compliance with local medical product laws and proper handling guidelines.

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Tags / Keywords

Enbrel, Etanercept Injection, TNF Inhibitor, Amgen Biologic, Rheumatoid Arthritis Treatment, Psoriatic Arthritis Therapy, Autoimmune Biologics, U.S.-Manufactured Etanercept, Global Supply Monoclonal Biologic, Original Brand Enbrel Not Biosimilar