Biosimilars Market: Transforming Pharma Dynamics

Biosimilars Market driving innovation and competition in pharma

A biosimilar is a type of biological product designed to closely resemble an existing FDA-approved reference product, with no significant differences in safety or effectiveness. With biologics accounting for nearly 40% of global pharmaceutical spending, the introduction of biosimilars offers a strategic opportunity to lower treatment costs while expanding patient access.

Biosimilars V/S Biologics

The Global Biosimilars Market was valued at USD 24.5 billion in 2023 & is projected to reach around USD 74.3 billion by 2030, expanding at a CAGR of 21.1% during the forecast period. As of April 2025, the U.S. FDA has approved a total of 74 biosimilars, with the most recent “Jobevne” receiving approval on April 9, 2025. The United States has firmly positioned itself at the forefront of biosimilar adoption, with the North American market surpassing $10 billion in value in 2024 alone.

As affordability, access, and adoption continue to rise, biosimilars are clearly reshaping the future of biologic treatment in the U.S. and beyond. The biosimilars market is expanding rapidly across all major regions, but adoption rates, regulatory environments, and therapeutic focus vary significantly. The United States is currently the largest biosimilars market projected to surpass $31 billion by 2030.

The following key underpins this dominance

Statistics:

Cost Efficiency of Biosimilars

• In 2023, cost savings from biosimilars surged by over 30%, reaching $12.4 billion. Since their launch, these medications have collectively saved $36 billion.

• Bringing a biosimilar to market typically costs $100 million to $250 million, compared to the $2.6 billion it can take to develop a new branded biologic.

• Biosimilars are projected to be as much as 35% cheaper than their branded counterparts, potentially contributing to a $100 billion reduction in U.S. drug costs between 2020 and 2024.

• Since the FDA approved the first biosimilar in 2015, these therapies have delivered significant cost savings, amounting to $23.6 billion for the U.S. healthcare system, according to a 2023 report by the Association of Accessible Medicines.

A significant cost-saving potential remains unexploited, with 90% of the 118 biologics set to lose exclusivity over the next decade amounting to a total value of $236 billion.

Patent protections and litigation are key factors in shaping the timeline for biosimilar market entry under the Biologics Price Competition and Innovation Act (BPCIA). The pharmaceutical market is currently experiencing "Wave 2" of patent expirations. The initial phase (2010–2020) introduced biosimilars for trastuzumab, infliximab, and rituximab, establishing a foundation for biosimilar adoption in autoimmune treatment and oncology segments. This second wave now encompasses the expiration of key monoclonal antibody patents, creating new market entry points for competitors and driving strategic opportunities for cost efficiencies across the healthcare industry. With over 50 blockbuster biologic drugs expected to lose patent exclusivity by 2032—many of which generate multi-billion-dollar annual revenues—the next decade will unlock immense opportunities for biosimilar developers.

Patent Expiration of Blockbuster Biologics

As part of the Biosimilar User Fee Act reauthorization commitment for fiscal years 2023–2027, the FDA plans to introduce a pilot regulatory science program focused on improving the development of interchangeable products & optimizing the development process of biosimilar products. The increasing availability of interchangeable biosimilars, particularly in the U.S. & Europe is expected to accelerate substitution & prescription flexibility. Enhancing market dynamics through initiatives such as provider education, patient awareness campaigns, and financial incentives has the potential to accelerate biosimilar adoption. The first quarter of 2025 has already seen a surge in biosimilar activity with multiple high-impact approvals.

Recent FDA Approvals:

• Jobevne, a biosimilar to Avastin, was approved on April 9, 2025, targeting various cancers

• Bomyntra and Conexxence were approved in March 2025 as biosimilars to Xgeva and Prolia, expanding competition in the bone health segment

• Omlyclo, a biosimilar to Xolair, received FDA clearance in March 2025, targeting allergic asthma and chronic idiopathic urticaria

• Osenvelt and Stoboclo, biosimilars to Prolia, were approved in February 2025, adding further pressure in the osteoporosis space

• Merilog, referencing NovoLog, was approved in February 2025, signaling continued expansion in diabetes care

Competitive Landscape

The biosimilar market is set to evolve into three distinct categories- emerging, established and smaller players. Leading companies like Samsung Bioepis, Sandoz and Amgen are expanding their portfolios with biosimilars targeting high-value drugs such as Opdivo & Keytruda. Meanwhile, emerging players like Biocad, Mabxience (Insud Pharma), Innovent Biologics & Luye Pharm are making strides with late-stage biosimilars for oncology indications. Additionally, smaller firms like Shanghai Henlius Biotech & Prestige Biopharma are entering the market, focusing on less competitive segments. To navigate this shifting landscape, manufacturers of reference product must assess incoming biosimilar competition, strategize launches for next-generation and monitor patent dynamics.

Market Trends & Opportunities:

• >$36 billion in cumulative U.S. healthcare savings from biosimilars (2015–2023)—with $12 billion saved in 2023 alone.

• U.S. biosimilars now achieve 53% average market share within 5 years of launch; oncology and supportive care products reach as high as 85–89%.

• Biosimilars for adalimumab (Humira) have launched at up to 86% lower WAC vs. originator, yet market share was only 2% as of end-2023, indicating massive room for growth.

• Over $270 billion worth of biologics are expected to lose exclusivity globally by 2032, opening the door for biosimilar entry.

• ASPs (Average Sales Prices) for biosimilars are typically 30–80% lower than their reference biologics, accelerating payer and provider adoption.

• Rising R&D investments in oncology, autoimmune, and endocrinology biosimilars are fueling innovation in highly reimbursed therapeutic areas.

• Over 60 biosimilars approved by the FDA and 700+ globally (approved or in pipeline), with emerging markets driving next-phase volume growth.

Sources:

·  https://www.biospace.com/press-releases/biosimilars-market-size-estimated-to-reach-usd-175-99-billion-by-2034

·  https://www.evaluate.com/press_release/evaluate-releases-2030-forecasts-for-global-pharmaceutical-market/

·  https://accessiblemeds.org/resources/blog/2023-savings-report/

·  https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/biosimilars-in-the-united-states-2023-2027

·  https://www.fda.gov/drugs/biosimilars/biosimilar-product-information

·  https://www.fda.gov/media/152279/download

·  https://www.greyb.com/blog/biologics-patents-expiring/

·  https://www.cardinalhealth.com/en/product-solutions/pharmaceutical-products/biosimilars/biosimilars-report.html

·  https://www.mckinsey.com/industries/life-sciences/our-insights/an-inflection-point-for-biosimilars

·  https://www.iqvia.com/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2023