Biocon Biologics Ltd, the biosimilars arm of Biocon Ltd, launched Nepexto®, a biosimilar to Enbrel® (etanercept), in Australia on July 23, 2025, partnering with Generic Health, a leading local distributor. This move expands affordable treatment options for autoimmune diseases, reinforcing Biocon’s global footprint in biologics.
Nepexto® targets conditions like rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and juvenile idiopathic arthritis by inhibiting tumor necrosis factor (TNF), a key inflammation driver. Enbrel®, developed by Amgen and co-marketed with Pfizer, is a costly blockbuster, often exceeding $50,000 annually, limiting access. Nepexto®, approved by Australia’s Therapeutic Goods Administration in September 2022 and listed on the Pharmaceutical Benefits Scheme (PBS) from July 1, 2025, offers a 30-50% cost reduction, making it the second etanercept biosimilar after Brenzys®.
The 2022 acquisition of Viatris’s biosimilars business for $3.3 billion enabled Biocon Biologics to fully integrate R&D and commercialization, operating in ~120 countries. CEO Shreevatsa called the launch a “milestone in delivering affordable biologics,” aligning with the company’s “Accelerate” phase to become a top global biosimilars player.
Generic Health will promote and distribute Nepexto®, leveraging Australia’s growing biosimilars market (15-20% CAGR). The launch follows Nepexto®’s success in Europe since 2020 and strengthens Biocon’s immunology portfolio, including adalimumab (Hulio®).
This entry comes amid industry tensions, with Pfizer’s 2022 patent suits against etanercept biosimilars in Australia and Sandoz’s 2025 US antitrust case against Amgen for alleged monopolistic tactics. Nepexto® could save Australia’s healthcare system millions, supporting global efforts to make biologics accessible while challenging Big Pharma’s grip.
