What biologics are available in India for the treatment of Inflammatory Bowel Disease (IBD)?

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Last updated: August 22, 2025 • View editorial policy

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Biologics Available in India for Inflammatory Bowel Disease (IBD)

Several biologics are available in India for the treatment of IBD, including anti-TNF agents (infliximab, adalimumab, golimumab), anti-integrin agents (vedolizumab), and interleukin inhibitors (ustekinumab).

Available Biologic Agents for IBD in India

Anti-TNF Agents

  1. Infliximab

    • Chimeric monoclonal antibody against TNF-alpha
    • Administration: Intravenous infusion
    • Indications: Both Crohn's disease (CD) and ulcerative colitis (UC)
    • Biosimilars are available in India, which may offer cost advantages 1

  2. Adalimumab

    • Fully human monoclonal antibody against TNF-alpha
    • Administration: Subcutaneous injection
    • Indications: Both CD and UC
    • Biosimilars are available in India 1, 2

  3. Golimumab

    • Fully human monoclonal antibody against TNF-alpha
    • Administration: Subcutaneous injection
    • Indication: UC (not approved for CD)

Anti-Integrin Agents

  1. Vedolizumab
    • Humanized monoclonal antibody targeting α4β7 integrin
    • Administration: Intravenous infusion
    • Indications: Both CD and UC
    • Gut-selective mechanism with favorable safety profile 1

Interleukin Inhibitors

  1. Ustekinumab
    • Monoclonal antibody targeting IL-12/IL-23
    • Administration: Initial IV infusion followed by SC maintenance
    • Indications: Primarily for CD, also approved for UC
    • Good safety profile based on long-term data 1

Clinical Positioning of Biologics

For Ulcerative Colitis

  • First-line biologics: Infliximab or vedolizumab are preferred first-line options for moderate-to-severe UC 1
  • Vedolizumab has shown superiority to adalimumab in the VARSITY trial 1
  • Infliximab has demonstrated superior efficacy compared to vedolizumab, adalimumab, ustekinumab, and ozanimod in network meta-analyses 1

For Crohn's Disease

  • For penetrating disease or multiple extraintestinal manifestations: Infliximab or adalimumab are preferred first-line agents 3
  • For inflammatory phenotype: Anti-TNF agents, vedolizumab, and ustekinumab are all reasonable options 3

Practical Considerations for Biologic Selection in India

Safety Profiles

  • Vedolizumab: Gut-selective mechanism with lower systemic immunosuppression; favorable safety profile with minimal risk of opportunistic infections 1
  • Ustekinumab: Lower risk of serious infections compared to anti-TNF agents 1
  • Anti-TNF agents: Higher risk of opportunistic infections and potential for immunogenicity 1, 2

Monitoring Requirements

  • Annual review of patients on biologics therapy is recommended 1
  • Pre-treatment screening for tuberculosis and other infections is essential before starting any biologic therapy, particularly important in India where TB prevalence is high 1
  • Monitor for adverse effects and therapeutic response

Biosimilars in India

  • Biosimilars of infliximab and adalimumab are available in India, offering more cost-effective options 1, 4
  • Important to note that biosimilars are not identical to reference products and may have subtle differences in manufacturing processes 1

Special Considerations

Infections

  • Screen for tuberculosis before starting any biologic therapy
  • Consider C. difficile testing in patients with IBD flares, especially those on immunosuppressive therapy 1
  • Vedolizumab may be preferred in patients with history of infections due to its gut-selective mechanism 1

Cost Considerations

  • Biosimilars offer a more cost-effective alternative to original biologics
  • The availability of biosimilars has improved access to biologic therapy in India 4

Emerging Biologics and Future Perspectives

Several newer agents are being developed or may become available in India in the future:

  • JAK inhibitors (tofacitinib) - oral small molecule for UC 5
  • Additional IL inhibitors - targeting various inflammatory pathways 6

While the range of biologics available in India continues to expand, providing more treatment options for IBD patients, the selection should be based on disease phenotype, safety profile, cost considerations, and patient preferences regarding administration route.

References

1
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

5
Research

Emerging biologics in inflammatory bowel disease.

Journal of gastroenterology, 2017

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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