The Rise of Biosimilars: Regulatory Pathways and Market Outlook

Biosimilars are changing the way healthcare systems manage the high cost of advanced medicines. These drugs are developed to be very similar to existing biologic treatments, which are often expensive but essential for patients with conditions such as cancer, diabetes, and autoimmune diseases. By offering equally safe and effective alternatives at a lower cost, biosimilars are helping make critical therapies more affordable and accessible.

This article explores what biosimilars are, how they differ from generics, and their significance in modern medicine. It also examines global regulatory pathways, development challenges, market trends, and the prospects of this expanding field.

What Are Biosimilars?

A biosimilar is a biological medicine that is highly similar to an already approved biologic drug. Importantly, an FDA‑approved biosimilar has no clinically meaningful differences in safety, purity, or potency compared to its reference product. In practical terms, patients can expect the same treatment results with a biosimilar as with the original biologic. Biosimilars are made using living cells or organisms (just like their reference biologics) and undergo rigorous comparative studies to ensure they match the reference drug in terms of structure, function, and clinical effect.¹

The introduction of biosimilars offers new therapeutic options, increasing competition, and potentially lowering costs for life‑saving treatments. For example, the World Health Organization notes that biosimilars are often about 60% cheaper than the original biologic products, which can significantly expand patient access to essential medicines, especially for costly conditions like cancer or autoimmune diseases.²

Biosimilars vs. Generics: Key Differences

Biosimilars and generics both aim to provide affordable alternatives to brand‑name drugs, but they are not the same. Generics are small‑molecule medicines made through chemical synthesis and are exact copies of their original drugs. Biosimilars, on the other hand, are large, complex proteins produced in living systems, making it impossible to create an identical copy. Instead, biosimilars must be shown to be highly similar to the reference biologic, with no meaningful differences in safety or effectiveness.

Both are approved through abbreviated regulatory pathways, but the process for biosimilars is more demanding. While generic approval mainly relies on proving chemical equivalence and bioavailability, biosimilar developers must conduct advanced analytical studies and, often, clinical trials to demonstrate similarity. This makes biosimilars more challenging and costly to produce than generics.

Despite these differences, both FDA‑approved generics and biosimilars meet strict safety and quality standards. In the U.S., biosimilars may also receive an “interchangeable” designation, allowing pharmacists to substitute them for the reference biologic without a new prescription, provided additional switching studies confirm safety.

Global Regulatory Pathways for Biosimilars

Around the world, health regulators have created clear frameworks to approve biosimilars, recognizing their role in making advanced therapies more affordable and accessible.

The European Union (EU) was the first to take the lead. In 2003, it set up a legal framework for biosimilars, and by 2006, the European Medicines Agency (EMA) had approved the world’s first biosimilar, a growth hormone called somatropin. Since then, the EMA has built one of the most robust systems for evaluating biosimilarity. By mid‑2025, it had already recommended more than 140 biosimilars for approval across different therapeutic areas. Europe’s experience has shown that biosimilars can be safely introduced into healthcare systems, setting an example for the rest of the world.³

In the United States, the biosimilar approval pathway was created in 2010 through the Biologics Price Competition and Innovation Act (BPCIA). The FDA approved its first biosimilar, Zarxio (filgrastim‑sndz), in 2015. Under the FDA’s framework, biosimilar applications must include detailed laboratory data and, in many cases, clinical study results to confirm there are no meaningful differences from the reference biologic. By May 2025, the FDA had approved about 75 biosimilars, covering treatments such as insulin, growth factors, and monoclonal antibodies. The FDA also goes a step further by granting some products an “interchangeable” designation, which allows pharmacists to substitute them for the original biologic without needing new prescriptions.⁴

Beyond the EU and US, countries like Japan, Canada, and India have also introduced their own biosimilar regulations, often drawing guidance from the World Health Organization (WHO) and the International Council for Harmonisation (ICH). The WHO continues to push for global standards, emphasizing that biosimilars must meet the same levels of safety, quality, and effectiveness as the original biologics. While requirements may differ slightly from country to country, such as the amount of clinical data required, the overall scientific principles remain the same. Regulators also collaborate internationally to share experiences and align their approaches, which is helping to bring greater harmony to biosimilar approvals worldwide.

Challenges in Development and Approval

●       Scientific and manufacturing complexity: Biosimilars are large protein‑based drugs made from living cells, unlike small‑molecule generics. Even minor changes in the production process, such as cell line selection or culture conditions, can alter the final product. To ensure safety and efficacy, developers must use advanced analytical tools and conduct clinical studies like pharmacokinetic (PK) and pharmacodynamic (PD) trials, sometimes extending to efficacy trials. This level of scrutiny makes biosimilar development time‑consuming (often 7–8 years) and extremely costly, with investments running into hundreds of millions of dollars.⁵

●       Evolving regulatory requirements: Although the FDA, EMA, and other regulators have established pathways, guidelines continue to evolve as more biosimilars are introduced. Requirements vary by country, with some agencies demanding extensive clinical data while others may allow streamlined approval if analytical similarity is strong. This lack of uniformity creates additional work for companies, which must adapt submissions to meet the standards of each market, slowing global launches and increasing development costs.

●       Patent and legal barriers: Biologic manufacturers often build dense “patent thickets” around their products, covering not only the active drug but also manufacturing methods and formulations. Navigating these overlapping patents can delay market entry and lead to costly litigation. For example, biosimilars of adalimumab (Humira) were approved in Europe as early as 2017, but U.S. patients only gained access in 2023 due to patent settlements and legal disputes. Under the U.S. Biologics Price Competition and Innovation Act (BPCIA), biosimilar companies must engage in lengthy “patent dance” negotiations and lawsuits, further delaying availability.⁶

●       Adoption and trust challenges: Even after regulatory approval, biosimilars can face hesitation from doctors, patients, and insurers. Concerns about switching from a trusted biologic to a biosimilar are common, especially for life‑threatening conditions like cancer or autoimmune diseases. Uptake depends heavily on education, clinical experience, and supportive policies. Some health systems encourage substitution through reimbursement incentives or by allowing pharmacists to dispense interchangeable biosimilars, while others remain more conservative. Building confidence among stakeholders is essential for widespread adoption.⁷

Market Trends and Impact

Strong market growth: The biosimilars sector has become one of the fastest‑growing areas in pharmaceuticals. Valued at around 25–30 billion USD in 2023, the global market is projected to more than double, reaching nearly 67 billion USD by 2028.⁸ This growth is fueled by two major factors: the expiration of patents on blockbuster biologics used in cancer, diabetes, and autoimmune conditions, and the increasing acceptance of biosimilars among healthcare providers and payers who are under pressure to reduce costs.

Significant cost savings: Competition from biosimilars is already reshaping drug pricing. In Europe, where biosimilars have been in use for over a decade, prices of several biologics have dropped steeply thanks to competitive tenders and pricing policies. The U.S., initially slower to embrace biosimilars, began catching up after 2023 when multiple biosimilars for Humira (adalimumab) launched. Within a year, Humira’s net price fell by about 38 percent compared to 2022, showing the powerful effect of biosimilar competition.⁹ Similar cost benefits are expected as more biosimilars for high‑cost biologics such as bevacizumab and trastuzumab enter the market.

Shift in payer and provider behavior: Insurance companies and healthcare providers are increasingly recognizing the economic advantages of biosimilars. Many formularies now prioritize biosimilars over branded biologics, encouraging their use through lower copays or favorable reimbursement terms. This has created a ripple effect: originator companies are being forced to lower prices or introduce their own competitive strategies. While manufacturers face strong price competition, this dynamic ultimately expands patient access and reduces healthcare spending.¹º

Rapid uptake in global markets: The European Union remains a leader, with some biosimilars capturing the majority of market share within just a few years of launch. In the United States, adoption is accelerating as providers gain confidence and as more products are approved with the FDA’s “interchangeable” designation, allowing pharmacists to substitute them without new prescriptions. This trend is expected to continue worldwide as awareness grows, policies strengthen, and healthcare systems look for sustainable ways to manage drug costs.

Future Outlook

The outlook for biosimilars is highly positive. Over the next decade, many leading biologic drugs will lose patent protection, paving the way for new biosimilars to become a standard part of treatment across oncology, immunology, ophthalmology, and other fields. This expansion is expected to save healthcare systems tens of billions of dollars while improving patient access.

As providers gain more confidence in biosimilars and as more products receive the FDA’s “interchangeable” status, adoption will accelerate globally. Regulators are also exploring streamlined approval processes, such as relying more on advanced analytics and reducing trial requirements when strong similarity is shown.

Global health authorities, including the WHO, continue to promote biosimilar adoption through supportive policies and incentives. Together, these changes position biosimilars as a cornerstone of affordable and sustainable healthcare in the coming years.

Summary

In summary, biosimilars are poised to become as common and as critical as generic drugs are today, only in the realm of complex biologic medicines. Their rise represents a win‑win: maintaining high standards of treatment while making therapy more affordable and accessible. The next decade should solidify the position of biosimilars as a foundation of sustainable and equitable healthcare.

FAQs

Q1: What is a biosimilar in simple terms?
 A: A biosimilar is a medicine very similar to an existing biologic drug. It is not an exact copy but it works the same way and is just as safe and effective.

Q2: How are biosimilars different from generic drugs?
 A: Generics are exact chemical copies of small‑molecule drugs, while biosimilars are made from living cells and can only be highly similar. Approval for biosimilars is more complex, but both are equally safe and effective once approved.

Q3: Are biosimilars as safe and effective as the original biologic?
 A: Yes. Regulators only approve biosimilars if studies prove they match the original drug’s safety and effectiveness.

Q4: How do biosimilars get approved by regulators?
 A: Developers must provide detailed lab and clinical data comparing them to the original. Approval is granted only if the evidence shows strong similarity.

Q5: Why are biosimilars important for healthcare?
 A: They lower the cost of expensive biologic drugs, often by 15–60%, making life‑saving treatments more affordable and accessible.

References

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Research C for DE and. Biosimilars Basics for Patients. FDA. Published online 2024. https://www.fda.gov/drugs/biosimilars/biosimilars-basics-patients

Amgen’s adalimumab biosimilar will only be launched in US in 2023. Gabionline.net. Published 2023. Accessed September 17, 2025. https://www.gabionline.net/biosimilars/news/Amgen-s-adalimumab-biosimilar-will-only-be-launched-in-US-in-2023?utm

FDA approves first biosimilar ZarxioTM (filgrastim-sndz) from Sandoz. Novartis Published 2015. Accessed September 17, 2025. https://www.novartis.com/news/media-releases/fda-approves-first-biosimilar-zarxiotm-filgrastim-sndz-from-sandoz

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ASDReports Market Research. Biosimilars Market - Global Forecast to 2028. Asdreports.com. Published June 23, 2023. Accessed September 17, 2025. https://www.asdreports.com/market-research-report-623044/biosimilars-market-global-forecast

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