Why Most Biosimilars don’t get Approved?

The global biosimilars market is expected to surpass $44.55 billion in 2025, driven by expiring biologic patents, rising demand for affordable therapies, and increased regulatory activity in the U.S., EU, and Asia. Yet, despite the momentum, regulatory bottlenecks continue to slow innovation. Unlike generic drugs, biosimilars face a far more complex and fragmented approval landscape.

Each region—be it the FDA in the U.S., EMA in Europe, or DCGI in India—demands distinct filing pathways, bridging studies, and often duplicative clinical trials. Even post-approval, launch delays from patent litigation, lack of interchangeability status, and poor dossier quality can stall commercial entry by years.

In some cases, a biosimilar approved in Europe or India still awaits U.S. clearance due to differing data standards or manufacturing compliance issues.
That gap isn't just regulatory, it’s a lost revenue window.

Top Reasons Biosimilar Applications Fail

Approvals don’t always mean market access. The real bottlenecks often lie outside the regulator’s office—in courtrooms and corporate boardrooms.

1. Patent Litigation Delays Entry

Even after biosimilars receive regulatory clearance, patent lawsuits can block launch for years. Take adalimumab (Humira), for example.

AbbVie sued nearly every biosimilar manufacturer—Amgen, Pfizer, Samsung Bioepis, Mylan, Sandoz, Boehringer Ingelheim—claiming patent infringement.

Most didn’t fight. They settled, agreeing to delay launch in exchange for future licensing. That’s why biosimilar versions of adalimumab didn’t reach U.S. shelves until January 2023, despite its main patent expiring in 2016.

2. Patent Thickets: Legal Wall Building

AbbVie filed over 100 patents around Humira. Not just on the molecule—but on manufacturing, formulation, and delivery methods. This tactic is called a “patent thicket.”

Here’s how it works:

• 89% of patents were filed after Humira entered the market.
• 49% came after the first patent expired in 2014.

These overlapping patents made legal clearance costly and slow, even for biosimilars with FDA approval.

3. Settlements That Come at a Cost

Many biosimilar manufacturers agreed to pay royalties and delay entry. The reward? Eventual market access. The cost? Years of lost revenue, and billions in extended brand-name sales. Adalimumab sales still top $10 billion annually, keeping costs high for payers and patients.

Even perfect dossiers can fail at launch. Regulatory approval is only part of the equation. Failing to prepare for litigation risk and patent strategy can destroy timelines.

Want to avoid this? Benchmark patent expiry, litigation trends, and licensing timelines—before you file.

Biosimilar Approvals in 2025

Biosimilar approvals haven’t surged. But they are moving—cautiously. In 2025, the FDA cleared six new biosimilars through the 351(k) pathway (as of mid-year).

Most are for oncology and autoimmune conditions—the two highest-value biologic markets.

Read our detailed article on Biosimilar Approvals in 2025 and Key FDA around the Industry

Top Biosimilar approvals by region

Global Biosimilar market vary significantly by region—each shaped by regulatory frameworks, market demand, and development pipelines.

United States

• The U.S. is experiencing a surge in FDA approval across therapy areas like oncology, immunology, endocrinology, and metabolic disorders
• As of mid-2025, FDA cleared several high-value monoclonal antibody and hormone-related biosimilars—such as ustekinumab (Starjemza), bevacizumab (Jobevne), and denosumab variants
• The US biosimilar market size is estimated to be $22.59 billion in 2025 and is expected to exceed $93.52 billion by 2034.

Europe

• Europe holds sustained leadership with a clear regulatory path and early adoption trends, supporting over 90 biosimilar approvals by 2024.
• The European market size is estimated at USD 15.3?billion in 2025, growing at ~16% CAGR through 2032.

Asia?Pacific

• The fastest-growing region: Asia?Pacific’s biosimilar market is projected to reach USD 2.86?B in 2025, expanding at roughly 31.6% CAGR through 2033.
• This growth is driven by local industry scale-up, supportive policies, and cost-sensitive healthcare demand in countries like India, China, and South Korea.

Rest of the World

• “Rest of the World” regions (Latin America, Middle East, Africa) are gradually integrating biosimilars.
• Expected market size is USD 3.8?B in 2025, with ~17.8% CAGR through 2034

Biosimilars vs. Generics

Confusing biosimilars with generics is a costly mistake. They follow different rules, require different data, and move through entirely different approval pathways.

Deep Dive into Key Differences between Biosimilars and Generic Drugs

1. Active Ingredient & Manufacturing: Generics use a strictly identical active ingredient. Biosimilars are made in living cells, so minor variability is expected—and regulated accordingly

2. Regulatory Approval Process: Generics rely on ANDA (505(j)), requiring bioequivalence. Biosimilars file under 351(k) BLA, proving high similarity and no clinically meaningful differences—a tougher bar

3. Clinical Data Requirements: Generics generally need pharmacokinetic bioequivalence trials only. Biosimilars must add patient or healthy volunteer trials, focusing on immunogenicity and PK/PD comparability .

4. Interchangeability & Substitution Rules: Most generics can be automatically substituted at pharmacies. Biosimilars need a separate “interchangeable” designation from the FDA. Without it, prescriber must explicitly allow substitution

Summary: Why the Gap Exists?

• Generics are simple molecules; biosimilars are large, living-cell-derived proteins.
• Regulatory agencies enforce stricter controls on biosimilars due to complexity and immunogenicity risk.
• For manufacturers, this means higher costs, longer timelines, and more data for approvals.

Conclusion

The biosimilar market in 2025 is worth over $44 billion globally. But capturing that value requires more than regulatory approval—it demands regulatory strategy.

Biosimilar developers face one of the toughest market-entry challenges in pharma.
Unlike generics, the biosimilar journey is slowed by:

• Patent thickets and litigation traps
• Fragmented regulatory pathways (FDA vs. EMA vs. DCGI)
• Long, expensive clinical requirements
• Interchangeability hurdles that limit substitution

And yet, those who navigate these challenges well—Biocon, Amgen, Samsung Bioepis—have carved multi-billion dollar wins from the complexity.

The difference? They use data. They don’t guess timelines, fail submission audits, or hope the FDA ignores gaps.

They benchmark everything:

• Time to approval by molecule and region
• CDMO/CRO partnerships per therapeutic area
• Litigation outcomes, market launch delays, and exclusivity cliffs

, If your biosimilar pipeline includes high-value biologics adalimumab, trastuzumab, ustekinumab—you can’t afford to move 

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