Australia Biosimilar Market

Australia Biosimilar Market Overview:

The Australia biosimilar market size reached USD 741.6 Million in 2024. Looking forward, IMARC Group expects the market to reach USD 5,512.5 Million by 2033, exhibiting a growth rate (CAGR) of 22.20% during 2025-2033. Australia’s market is growing steadily, driven by supportive government policies, PBS listings, and rising demand for affordable biologic treatments. Increasing clinical trial activity and broader acceptance among healthcare providers are also encouraging biosimilar development, competition, and early adoption across key therapeutic areas.

Australia Biosimilar Market Trends:

Policy Backing Expands Treatment Access

Australia’s market is being shaped by regulatory support and national reimbursement strategies. The government’s focus on affordable biologics has enabled broader access to advanced therapies while encouraging competition among biosimilar developers. A key driver has been the Pharmaceutical Benefits Advisory Committee (PBAC), which evaluates medicines for subsidization under the Pharmaceutical Benefits Scheme (PBS). These evaluations are essential to ensure patients receive cost-effective treatments without compromising on quality. In May 2024, PBAC recommended Amgen’s Wezlana, the first ustekinumab biosimilar, for PBS listing. This recommendation followed the product’s approval by the Therapeutic Goods Administration (TGA) in January 2024. Wezlana was approved for Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis—indications previously served only by higher-cost originator products. This move signaled a turning point, encouraging the integration of biosimilars into frontline treatment plans. The market has since seen greater acceptance among healthcare providers and improved availability across healthcare systems. As a result, patients now have more affordable alternatives, and biosimilar developers gain confidence to enter the Australian market. With continued PBAC endorsements and streamlined pathways for PBS listings, market participants are expected to increase, boosting availability and reducing therapy costs in chronic disease care.

Clinical Research Enhances Market Credibility

Australia’s strong clinical research environment is reinforcing its position in the global biosimilar space. The country’s regulatory stability, experienced trial infrastructure, and high standards of data collection attract international developers to base early-phase studies here. These trials not only bring investment but also affirm Australia’s scientific role in biosimilar validation. A key example is the Phase I study of SELARSDI (ustekinumab-taken), conducted in April 2024 by Alvotech and Teva in both Australia and New Zealand. This trial played a pivotal role in securing the U.S. FDA’s approval of SELARSDI. Though the commercial launch targets the U.S. market in 2025, the research base tied to Australia strengthens its global standing in biosimilar development. The country benefits from being seen as a credible site for high-quality early clinical programs. This encourages international collaboration and improves local expertise in biosimilar protocols. As more companies conduct studies in Australia, data generated here will increasingly influence regulatory decisions worldwide. This raises the country’s profile as not just a consumer of biosimilars but as a foundational part of their development. Growing clinical involvement is likely to result in earlier product availability domestically, improved physician trust, and smoother future regulatory approvals.

Australia Biosimilar Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the country level for 2025-2033. Our report has categorized the market based on molecule, manufacturing type, and indication.

Molecule Insights:

• Infliximab
• Insulin Glargine
• Epoetin Alfa
• Etanercept
• Filgrastim
• Somatropin
• Rituximab
• Follitropin Alfa
• Adalimumab
• Pegfilgrastim
• Trastuzumab
• Bevacizumab
• Others

The report has provided a detailed breakup and analysis of the market based on the molecule. This includes infliximab, insulin glargine, epoetin alfa, etanercept, filgrastim, somatropin, rituximab, follitropin alfa, adalimumab, pegfilgrastim, trastuzumab, bevacizumab, and others

Manufacturing Type Insights:

• In-house Manufacturing
• Contract Manufacturing

A detailed breakup and analysis of the market based on the manufacturing type have also been provided in the report. This includes in-house manufacturing and contract manufacturing.

Indication Insights:

• Auto-Immune Diseases
• Blood Disorder
• Diabetes
• Oncology
• Growth Deficiency
• Female Infertility
• Others

A detailed breakup and analysis of the market based on the indication have also been provided in the report. This includes auto-immune diseases, blood disorder, diabetes, oncology, growth deficiency, female infertility, and others.

Regional Insights:

• Australia Capital Territory & New South Wales
• Victoria & Tasmania
• Queensland
• Northern Territory & Southern Australia
• Western Australia Canada

The report has also provided a comprehensive analysis of all the major regional markets, which include Australia Capital Territory & New South Wales, Victoria & Tasmania, Queensland, Northern Territory & Southern Australia, and Western Australia.

Competitive Landscape:

The market research report has also provided a comprehensive analysis of the competitive landscape. Competitive analysis such as market structure, key player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant has been covered in the report. Also, detailed profiles of all major companies have been provided.

Australia Biosimilar Market News:

• November 2024: Australia’s ARTG approved five new denosumab brands by Amgen, signaling anticipation of biosimilar competition. This followed August 2024 approvals of Sandoz’s biosimilars, Jubbonti and Wyost. The development boosted market readiness, increasing competition and paving the way for wider biosimilar access.
• October 2024: Australia’s TGA approved Samsung Bioepis’ Epyztek, a ustekinumab biosimilar, in three formulations. This marked the fourth ustekinumab biosimilar approval, strengthening biosimilar competition. The move expanded treatment options and was expected to reduce costs, supporting broader market acceptance and adoption of biosimilars.

Australia Biosimilar Market Report Coverage:

Key Questions Answered in This Report:

• How has the Australia biosimilar market performed so far and how will it perform in the coming years?
• What is the breakup of the Australia biosimilar market on the basis of molecule?
• What is the breakup of the Australia biosimilar market on the basis of manufacturing type?
• What is the breakup of the Australia biosimilar market on the basis of indication?
• What are the various stages in the value chain of the Australia biosimilar market? 
• What are the key driving factors and challenges in the Australia biosimilar market?
• What is the structure of the Australia biosimilar market and who are the key players?
• What is the degree of competition in the Australia biosimilar market? 

Key Benefits for Stakeholders:

• IMARC’s industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the Australia biosimilar market from 2019-2033.
• The research report provides the latest information on the market drivers, challenges, and opportunities in the Australia biosimilar market.
• Porter's five forces analysis assist stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the Australia biosimilar industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.