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Why 2026 is a turning point for Biosimilar Developers?

2025 has been a pivotal year for biosimilars. New regulatory expectations, stronger analytical frameworks, and a renewed emphasis on lifecycle monitoring have pushed developers closer than ever to one key truth:

Biosimilars are no longer approved by similarity alone — they are sustained by consistency.

This insight wasn’t abstract. It echoed through nearly every conversation, panel, and session at the Biosimilars Congregation 2025, organized by Virtue Insight—one of India’s leading platforms for strategic scientific conferences (Virtue Insight).

And in many ways, the discussions this week pointed toward a reality the industry is steadily moving into:

2026 will be the year biosimilar development becomes more demanding, more data-driven and more analytically disciplined than ever before.

1. The Momentum of 2025:

Biosimilar development has matured significantly over the past decade. However, what stood out in 2025 was not the number of approvals — but the depth of scrutiny around comparability, QC robustness, immunogenicity, RWE, and lifecycle management.

Globally, regulators are consistently raising expectations:

  • The FDA’s biosimilar guidance emphasizes “substantial analytical similarity supported by robust data.”
    (FDA Guidance)
  • EMA continues to expand its requirement for immunogenicity monitoring and long-term consistency.
    (EMA Biosimilars)
  • Markets like Brazil, South Korea and Saudi Arabia are aligning with higher comparability standards.

The takeaway:
Analytical evidence now shapes regulatory and commercial success more than ever.

But at the congregation, a deeper theme emerged, one that directly affects 2026:

Regulators trust data that is reproducible, traceable, and generated with rigour, not just data that meets “minimum” similarity thresholds.

2. Lessons from Biosimilars Congregation 2025

Virtue Insight’s event brought together experts from Pfizer, GSK, Sandoz, Hetero, Cipla, and more creating a space where science, policy, and industry realities converged.

Across panels and discussions, five insights stood out.

1: Real-World Evidence (RWE) is becoming the New Benchmark

The panel “Beyond the Trial: RWE as the New Benchmark for Biosimilar Approval” highlighted a major shift:

Clinical trial success is no longer enough. RWE drives long-term acceptance.

RWE helps answer:

  • Does the biosimilar maintain effectiveness across diverse populations?
  • Are immunogenicity patterns stable during real-world switching?
  • Do QC and manufacturing controls hold up at scale?

2026 will see regulators place more weight on RWE during both approval and post-marketing surveillance, especially in immunology and oncology.

2: QC weaknesses are still a Major Bottleneck

Developers repeatedly cited challenges with:

  • Host Cell Protein (HCP) variability
  • Host cell DNA fluctuations
  • ADA assay sensitivity
  • Lot-to-lot drift in reagents
  • TMB backgrounds impacting LOD/LOQ
  • Recombinant protein instability
  • Workflow reproducibility

Surprisingly, more than 50% of analytical delays in biosimilar programs arise from QC variability, according to multiple industry reports (Nature).

2026 will magnify this problem unless teams modernize their QC systems.

3: Immunogenicity is now the Gatekeeper

ADA assays are under heavier scrutiny than ever.

Regulators expect:

  • Higher sensitivity
  • Lower background
  • Better-neutralizing antibody detection
  • Traceability
  • Lifecycle monitoring, not one-time assessments

This directly affects market acceptance and switching confidence.

4: Comparability is moving from Event to Lifecycle

Comparability is no longer a “stage.”
It is a continuous discipline that spans:

  • analytical characterization
  • manufacturing scale-up
  • process changes
  • site transfers
  • regulatory re-evaluations
  • post-market monitoring

2026 biosimilars must prove stability not just at launch—but across years of manufacturing.

5: Better Tools are becoming Non-Negotiable

One message echoed loudly:

Strong biosimilars come from strong analytics.
Strong analytics come from strong reagents.

Teams can no longer afford:

  • inconsistent antibodies
  • unstable recombinant proteins
  • unpredictable substrates
  • cell media with batch drift
  • low-grade QC standards
  • poorly optimized ELISA kits

The margin for error is collapsing.

3. Why 2026 will be a turning point for Biosimilars

Based on regulatory trends, global competition, and insights from the congregation — 2026 is shaping up to be a transformative year.

1. Regulatory expectations will intensify

More emphasis on:

  • RWE
  • ADA sensitivity
  • QC traceability
  • analytical similarity depth
  • stability and stress characterization

2. Price competition will force data-driven differentiation

Cheaper biosimilars won’t win — reliable ones will.

3. Scale-up will demand better process analytics

Manufacturing consistency will become a competitive advantage, not a compliance checkbox.

4. Lifecycle monitoring will define market trust

From hospitals to payers, long-term consistency will matter more than initial similarity.

5. Global market expansion will bring stricter harmonization

Developers must prepare for cross-market analytical expectations.

4. The new Non-Negotiables for Biosimilar Teams

• High-sensitivity ADA / PK / immunogenicity assays.

• Better QC tools (HCP, DNA, process impurities)

• Substrates with tighter kinetic profiles

• Cell & protein assays designed for lifecycle reproducibility

• Custom assay development for molecule-specific requirements

5. Where Biosimilar Developers struggle?

The gap between expectations and tools is widening.

Teams reported challenges with:

  • assay variability across sites
  • switching studies impacted by ADA noise
  • reagent drift affecting comparability
  • inconsistent assay performance during scale-up
  • non-reproducible reference standards
  • regulatory pushback on assay design.

6. How deNOVO supports Biosimilar Programs?

deNOVO supports biosimilar developers through high-quality tools engineered for consistency, sensitivity, and reproducibility.

Our key strengths include:

1. Validated PK/ADA ELISA Kits

2. High-Sensitivity TMB Substrates

3. Recombinant Proteins & Antigens

4. QC Assays for HCP, E. coli DNA, CHO DNA

5. Cell Culture Media & Buffers

6. Custom Antibody Development & SPR Characterization

7. Custom Assay Development

7. The Future

2026 will reward teams who:

  • invest in analytical strength
  • view QC as strategic, not operational
  • adopt high-quality reagents
  • build lifecycle-ready assays
  • use RWE proactively

The science is advancing.
Regulations are tightening.
Expectations are rising.

The teams that prioritize consistency will be the teams that succeed.

If your biosimilar program needs support with:

  • ADA/PK assays
  • QC impurity detection
  • recombinant proteins
  • high-performance substrates
  • custom assay development
  • analytical troubleshooting

deNOVO can help strengthen your analytical foundation.

Reach out at denovobiolabs.com or message us directly for a technical discussion.

Let’s build biosimilars that regulators, clinicians and patients can trust.

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