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Comparison of Access to Novel Drugs for Lymphoma and Chronic Lymphocytic Leukemia Between India and the United States
lymphoma leukemia India United States biosimiliars

Comparison of Access to Novel Drugs for Lymphoma and Chronic Lymphocytic Leukemia Between India and the United States

  • by Vishwanath Sathyanarayanan, MD, DM, Christopher R. Flowers, MD, MSc, and Swaminathan P. Iyer, MD, MBBS
  • Jul 21st 2020
  • 12 mins
  • JCO Global Oncology, Volume 6, 1124-1133

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Summary

  • The review examines the costs and access to novel drugs for treating chronic lymphocytic leukemia (CLL) and lymphoma in the United States and India over the last 5 years.
  • Clinical outcomes for patients with hematologic malignancies have improved significantly due to immunotherapeutic and targeted therapies.
  • These novel drugs, initially approved in the United States, have also become available in India, enhancing patient access.
  • Patent expirations have led to the availability of generic versions, improving accessibility and lowering patient costs.
  • Biosimilars provide an additional pathway for expanding access to biologic compounds, further reducing development and patient costs.
  • Despite differences in cancer care delivery between the United States and India, the introduction of biosimilars and generics has helped align treatment outcomes and quality of life.
  • Compulsory licensing and capping of drug prices, as supported by the Doha Declaration, could further enhance global access to treatments for CLL and lymphoma.

Blood cancers are a significant public health problem worldwide and a leading cause of death in the United States and India. According to GLOBOCAN 2018, the annual incidence of lymphoma is 82,548 in the United States and 37,225 in India. The annual incidence of chronic lymphocytic leukemia (CLL) was 50,149 in the United States and 42,055 in India. Over the past 5 years, the US Food and Drug Administration (FDA) has approved 24 new indications in lymphoma and 11 in CLL. Most clinical trials for these novel drugs are conducted in the United States, and the drugs are available for use soon after, but only in the United States. The approval process for new drugs in India is managed by the Central Drugs Standard Control Organization and generally lags behind approval in the United States by at least 2 years. In addition, a decade can elapse before generics and biosimilars reach clinical practice. Our study aims to increase understanding of the similarities and differences regarding cancer care delivery, accessibility, cost, and the potential impact on survival for patients in the United States and India with the advent of these novel drugs for lymphoma and CLL.

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lymphoma, leukemia, India, United States, biosimiliars

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