FDA Approval of First Golimumab Biosimilars Accelerates Global Market Growth

Biosimilars Market Size to Hit USD 86.28 Billion by 2030 as FDA Clears First Golimumab Biosimilars

The global biosimilars market is witnessing accelerated regulatory and commercialization momentum after the U.S. Food and Drug Administration approved the first golimumab biosimilars for rheumatoid arthritis and ulcerative colitis, while Switzerland-based Polpharma Biologics entered a strategic Latin American licensing partnership with Tuteur to expand autoimmune biosimilar access across the region. 

The developments come as latest NMSC proprietary analysis projects the global Biosimilars Market will reach USD 86.28 billion by 2030, growing at a CAGR of 15.8% from 2024 to 2030.

The FDA approvals and cross-border commercialization agreement reflect a broader structural shift across the biologics industry, where healthcare systems, pharmaceutical manufacturers, and insurers are increasingly prioritizing lower-cost biologic alternatives to manage rising chronic disease treatment expenditures.

According to the latest NMSC proprietary dataset, biosimilar adoption has accelerated sharply during the last two quarters due to patent expirations, expanding physician confidence, and increased regulatory support across autoimmune and oncology therapeutic categories.

FDA Approval Marks Turning Point for Autoimmune Biosimilars

The U.S. FDA approved golimumab-sldi biosimilars, marketed as Immgolis and Immgolis Intri, as interchangeable alternatives to Simponi and Simponi Aria for rheumatoid arthritis and ulcerative colitis treatments. The approval represents the first biosimilar authorization for these reference biologics and is expected to intensify pricing competition within the TNF inhibitor segment.

The newly approved biosimilars will be commercialized in the United States through a partnership between Bio-Thera Solutions and Accord BioPharma. Regulatory authorities stated that the biosimilars demonstrated no meaningful clinical differences compared to the reference biologics in terms of efficacy, safety, and immunogenicity.

The FDA also noted that pharmacies may substitute the products for branded golimumab therapies where state laws permit interchangeable biosimilar dispensing.

Jayanta Das, Senior Research Analyst at Next Move Strategy Consulting, stated that recent FDA biosimilar approvals are reshaping competitive dynamics across autoimmune therapeutics.

“According to the latest NMSC proprietary dataset, healthcare providers and insurers are significantly expanding biosimilar integration strategies as interchangeability approvals improve physician confidence and reimbursement flexibility,” Das noted.

The regulatory decision also arrives amid ongoing patent litigation involving Janssen Biotech over additional indications tied to psoriatic arthritis and ankylosing spondylitis therapies.

Polpharma-Tuteur Partnership Expands LATAM Biosimilar Race

Separately, Polpharma Biologics signed a licensing agreement with Tuteur granting Tuteur exclusive commercialization rights for an autoimmune disease biosimilar across Latin America excluding Brazil.

Under the agreement, Polpharma Biologics will oversee product development and manufacturing, while Tuteur will manage regional marketing, distribution, and commercialization operations. The biosimilar candidate is currently under development, with regulatory submission expected within the next three years.

Industry analysts view the agreement as part of a growing wave of regional biosimilar alliances designed to improve biologic accessibility in emerging healthcare markets where treatment affordability remains a major concern.

NMSC researchers identified a notable increase in licensing and distribution partnerships during the past six months as manufacturers prepare for multiple high-value biologic patent expirations through 2028.

Market Momentum Accelerates Across Key Therapeutic Segments

The biosimilars market has experienced rapid transformation during 2025 and early 2026, driven by several structural developments:

• Increasing patent expirations of blockbuster biologic drugs 

• Expanding payer support for lower-cost biologic alternatives 

• Rising incidence of autoimmune diseases and cancer globally 

• Improvements in biologics manufacturing capabilities 

• Faster regulatory review pathways in developed markets 

According to NMSC analysis, oncology and immunology remain the highest-growth biosimilar categories due to rising specialty drug expenditures and strong payer-driven substitution strategies.

Competitive Pressure Intensifies Among Biopharma Companies

Leading biosimilar developers are accelerating investment into:

• Monoclonal antibody biosimilar pipelines 

• AI-assisted biologics manufacturing optimization 

• Regional licensing agreements 

• Advanced cell-line development technologies 

• Autoimmune and oncology-focused biologics portfolios 

NMSC analysts observed increased competition among multinational pharmaceutical firms and emerging biosimilar specialists seeking early positioning in post-patent biologics markets.

Key Strategic Trends in the Biosimilars Industry

Healthcare Systems Push for Cost Optimization

Healthcare providers globally continue facing mounting pressure to control specialty pharmaceutical expenditures. Biosimilars are increasingly viewed as a key mechanism for improving patient access while reducing long-term treatment costs.

According to NMSC proprietary research, hospital procurement agencies and pharmacy benefit managers have accelerated biosimilar inclusion programs following recent interchangeable approval decisions in the United States and Europe.

The latest market activity also indicates stronger investor interest in companies with scalable biologics manufacturing capabilities and established regulatory expertise.

What CEOs and Investors Should Do Next

• Expand regional licensing agreements ahead of upcoming biologic patent cliffs 

• Increase investment in autoimmune and oncology biosimilar pipelines 

• Strengthen regulatory strategy teams focused on interchangeable approvals 

• Scale biologics manufacturing infrastructure to meet future demand 

• Develop payer-focused commercialization strategies centered on affordability and accessibility 

About Next Move Strategy Consulting:

Next Move Strategy Consulting is a premier market research and management consulting firm that has been committed to provide strategically analysed well documented latest research reports to its clients. The research industry is flooded with many firms to choose from, what makes NMSC different from the rest is its top-quality research and the obsession of turning data into knowledge by dissecting every bit of it and providing fact-based research recommendation that is supported by information collected from over 500 million websites, paid databases, industry journals and one on one consultations with industry experts across a diverse range of industry sectors. The high-quality customized research reports with actionable insights and excellent end-to-end customer service help our clients to take critical business decisions that enables them to move beyond time and have competitive edge in the industry.

We have been servicing over 1000 customers globally that includes 90% of the Fortune 500 companies over a decade. Our analysts are constantly tracking various high growth markets and identifying hidden opportunities in each sector or the industry. We provide one of the industry’s best quality syndicate as well as custom research reports across 10 different industry verticals. We are committed to deliver high quality research solutions in accordance to your business needs. Our industry standard delivery solutions that ranges from the pre consultation to after-sales services, provide an excellent client experience and ensure right strategic decision making for businesses.

For more information, please contact:

Next Move Strategy Consulting

5th Floor 867

Boylston St, STE 500,

Boston, MA 02116, U.S.

E-Mail: [email protected]

Direct: +1-217-650-7991

Website: www.nextmsc.com