How India Exports Adalimumab to the World

In the United States, adalimumab is subject to the Biologics License Application (BLA) pathway, as it is a biologic product. The FDA's Orange Book provides comprehensive information on approved drug products, including adalimumab and its biosimilars. As of March 2026, several biosimilar versions of adalimumab have received FDA approval, enhancing market competition and accessibility. Notably, the approval of these biosimilars reflects the FDA's commitment to expanding treatment options for patients with autoimmune diseases.

Given the complexity of biologic products, the FDA imposes stringent requirements for the approval of biosimilars, including demonstrating similarity to the reference product in terms of safety, purity, and potency. The presence of 67 active Indian exporters underscores India's significant role in the global supply chain for adalimumab. However, Indian manufacturers aiming to enter the U.S. market must navigate the rigorous BLA process and adhere to the FDA's stringent regulatory standards.

In the European Union, the European Medicines Agency (EMA) oversees the approval of medicinal products, including biosimilars like adalimumab. The EMA has granted marketing authorizations for several adalimumab biosimilars; however, some, such as Halimatoz, Kromeya, Cyltezo, and Solymbic, had their authorizations withdrawn between 2018 and 2020 at the request of the marketing authorization holders for commercial reasons. Despite these withdrawals, other biosimilars remain authorized and marketed within the EU.

The United Kingdom, following its departure from the EU, has established its own regulatory framework through the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA continues to assess and authorize biosimilars, including adalimumab, ensuring they meet the necessary standards for safety, efficacy, and quality.

Both the EMA and MHRA require compliance with Good Manufacturing Practice (GMP) standards, which are critical for ensuring product quality and patient safety. Indian exporters must demonstrate adherence to these standards to gain and maintain market access in the EU and UK.

The World Health Organization (WHO) includes adalimumab in its Model List of Essential Medicines, recognizing its importance in treating conditions like ankylosing spondylitis, Crohn's disease, juvenile idiopathic arthritis, and rheumatoid arthritis. The 2023 Model List also acknowledges therapeutic alternatives such as certolizumab pegol, etanercept, golimumab, and infliximab. (who.int)

Inclusion in the WHO Model List signifies the global health community's recognition of adalimumab's essential role in managing autoimmune diseases. This designation can influence national formularies and procurement decisions, potentially impacting export opportunities for Indian manufacturers.

In India, adalimumab is classified under Schedule H of the Drugs and Cosmetics Rules, indicating that it is a prescription-only medication. The Central Drugs Standard Control Organization (CDSCO) oversees the regulation of such drugs, ensuring their safety and efficacy.

The National Pharmaceutical Pricing Authority (NPPA) monitors and regulates the prices of essential medicines in India. While specific ceiling prices for adalimumab are subject to periodic revisions, the NPPA's role is crucial in ensuring affordability and accessibility.

For exports, Indian manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with national regulations and facilitating international trade.

The original patents for adalimumab have expired in several jurisdictions, leading to increased generic competition and the introduction of biosimilars. This shift has expanded market opportunities for Indian exporters, allowing them to supply biosimilar versions to various countries.

In February 2025, the WHO highlighted the role of biosimilars in expanding access to essential biologic therapies, emphasizing the importance of regulatory frameworks to ensure their quality and efficacy. (who.int)

In April 2025, the WHO unveiled a global repository for National Essential Medicines Lists (nEMLs), providing a centralized platform for accessing information on essential medicines, including adalimumab. (who.int)

These developments underscore the evolving landscape of biosimilar regulation and the increasing emphasis on ensuring access to essential medicines globally.

India's pharmaceutical industry, including the production of Adalimumab, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 60–70% of India's API and KSM requirements are sourced from China, underscoring a significant dependency on Chinese suppliers. This reliance exposes the supply chain to vulnerabilities stemming from geopolitical tensions, trade disputes, and regulatory changes in China.

Recent disruptions have highlighted these risks. In September 2025, China implemented a price reduction of 40–50% on 41 APIs and KSMs, including critical components for antibiotics, aiming to undercut Indian manufacturers. Such aggressive pricing strategies can destabilize Indian API production, leading to potential shortages and increased costs for Adalimumab manufacturers.

Our proprietary trade data indicates that the top five Indian exporters of Adalimumab account for 41.5% of total exports, with RELIANCE LIFE SCIENCES PRIVATE LIMITED alone contributing 28.3%. This concentration suggests a moderate risk, as disruptions affecting these key suppliers could significantly impact the global supply of Adalimumab.

To mitigate such risks, the Indian government has introduced the Production Linked Incentive (PLI) scheme, aiming to bolster domestic API and KSM production. By November 2024, two greenfield plants were inaugurated under this scheme to manufacture essential molecules like Penicillin G and Clavulanic Acid, reducing import dependence. While these initiatives are promising, their impact on Adalimumab's supply chain remains to be fully realized.

Geopolitical tensions have posed significant threats to pharmaceutical supply chains. In June 2025, Iran's parliament voted to close the Strait of Hormuz in response to U.S. military actions, jeopardizing the transit of 20% of global oil and LNG trade. (pharmasource.global) Such disruptions can lead to increased transportation costs and delays in the delivery of raw materials essential for Adalimumab production.

Additionally, the closure of the Strait of Hormuz in February 2026 disrupted the supply of raw materials to Asia's petrochemical industry, leading to production cutbacks and force majeure declarations. These events underscore the fragility of supply chains reliant on specific shipping routes and geopolitical stability.

• Diversify API and KSM Sources: Encourage the development of alternative suppliers in different regions to reduce dependency on a single country.

• Strengthen Domestic Production: Accelerate the implementation of the PLI scheme to enhance local manufacturing capabilities for critical APIs and KSMs.

• Enhance Supplier Audits: Conduct regular assessments of key suppliers to ensure compliance with quality standards and to identify potential risks early.

• Develop Contingency Plans: Establish robust strategies to address potential disruptions, including alternative shipping routes and emergency stockpiles.

• Monitor Geopolitical Developments: Stay informed about international events that could impact supply chains and adjust procurement strategies accordingly.

RISK_LEVEL: MEDIUM