How India Exports Bevacizumab to the World

In the United States, bevacizumab is approved under the brand name Avastin, with the original approval granted to Genentech, Inc. The FDA has also approved biosimilar versions, such as Mvasi (approved in September 2017) and Zirabev (approved in June 2019). These approvals are documented in the FDA's Orange Book. The regulatory pathway for biosimilars involves demonstrating high similarity to the reference product without significant clinical differences. Given the substantial number of Indian exporters (196) involved in bevacizumab exports, compliance with FDA regulations, including adherence to Good Manufacturing Practices (GMP) and successful completion of the Biologics License Application (BLA) process, is imperative for market entry into the U.S.

In the European Union, the European Medicines Agency (EMA) oversees the approval of medicinal products. Bevacizumab is marketed under various names, including Avastin. Biosimilar approvals have been granted, such as Onbevzi, which received marketing authorization on January 11, 2021. However, Onbevzi's authorization was withdrawn on December 11, 2023, at the request of the marketing authorization holder for commercial reasons. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) aligns closely with EMA standards, requiring comprehensive data on quality, safety, and efficacy for marketing authorization. Manufacturers must comply with EU Good Manufacturing Practice (GMP) guidelines to ensure product quality and safety.

Bevacizumab is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its significance in treating various cancers. The WHO Prequalification Programme evaluates medicines to ensure they meet global standards of quality, safety, and efficacy, facilitating procurement by international agencies. Bevacizumab formulations are expected to comply with pharmacopoeial standards such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring consistency and quality across different markets.

In India, bevacizumab is classified under Schedule H of the Drugs and Cosmetics Rules, indicating it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) regulates the pricing of essential medicines; however, as of the latest data, bevacizumab is not listed under the Drug Price Control Order (DPCO), allowing manufacturers to set prices based on market dynamics. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure compliance with national regulations and to monitor the quality of pharmaceutical products leaving the country.

The primary patents for bevacizumab have expired, leading to increased generic competition and the development of biosimilars. This has resulted in more affordable options for patients and expanded market opportunities for manufacturers. However, companies must navigate complex patent landscapes and ensure their products do not infringe on existing intellectual property rights.

In May 2025, the FDA approved a new biosimilar version of bevacizumab, further increasing competition in the U.S. market. In July 2025, the EMA updated its guidelines on biosimilar development, emphasizing the need for robust analytical and clinical data to demonstrate similarity to reference products. In September 2025, the NPPA conducted a review of anti-cancer drug prices, including bevacizumab, to assess affordability and accessibility for patients in India. In November 2025, the WHO added a new formulation of bevacizumab to its Model List of Essential Medicines, recognizing its importance in treating additional cancer types. In January 2026, the DGFT implemented stricter export controls on biological products, including bevacizumab, to ensure quality standards are maintained in international markets.

These developments reflect the dynamic nature of the pharmaceutical industry and the importance of regulatory compliance in maintaining market access and ensuring patient safety.

Bevacizumab, a monoclonal antibody used in various cancer treatments, requires complex manufacturing processes involving specific active pharmaceutical ingredients (APIs) and key starting materials (KSMs). India, a major producer of generic pharmaceuticals, often relies on China for a significant portion of these KSMs. China controls approximately 70–80% of the global KSM supply and 60–70% of intermediate supplies, making it a dominant player in the pharmaceutical raw material market.

This dependency poses a risk to the supply chain, as any disruptions in China's production or export activities can directly impact India's ability to manufacture Bevacizumab. For instance, geopolitical tensions, environmental regulations, or logistical challenges in China can lead to delays or shortages in KSM availability, thereby affecting the production timelines and costs for Indian pharmaceutical companies.

Our proprietary trade data from 2022 to 2026 indicates a high concentration among Bevacizumab exporters in India. The top five exporters account for 83.9% of the total export value, with DR. REDDY'S LABORATORIES LTD alone contributing 47.2% ($22.1 million USD). This significant concentration increases the risk of supply chain disruptions, as any operational issues within these key companies could substantially impact global availability.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to boost domestic manufacturing of critical APIs and reduce reliance on imports. While this initiative is a positive step towards enhancing supply chain resilience, its effectiveness in diversifying the supplier base for Bevacizumab remains to be fully realized.

Recent geopolitical events have further strained the pharmaceutical supply chain. In February 2026, the closure of the Strait of Hormuz due to escalating conflicts disrupted global shipping routes, leading to delays and increased transportation costs for pharmaceutical products. Additionally, tensions in the Red Sea region have compelled shipping companies to reroute vessels around the Cape of Good Hope, adding approximately 10 to 14 days to transit times.

These disruptions have prompted regulatory bodies like the FDA to monitor potential drug shortages closely. The FDA actively works with industry partners to identify and address supply chain vulnerabilities, ensuring continued access to essential medicines.

• Diversify Supplier Base: Encourage the development of alternative suppliers for Bevacizumab and its raw materials to reduce dependency on a limited number of exporters.

• Enhance Domestic Production: Support initiatives like the PLI scheme to strengthen domestic manufacturing capabilities for critical APIs and KSMs.

• Strengthen Logistics Infrastructure: Invest in resilient logistics networks to mitigate the impact of geopolitical disruptions on shipping routes.

• Monitor Regulatory Developments: Stay informed about international regulatory changes and potential trade restrictions that could affect the supply chain.

• Develop Contingency Plans: Establish comprehensive risk management strategies, including maintaining buffer stocks and identifying alternative transportation routes.

RISK_LEVEL: HIGH