June 13, 2024
Immuno-Oncology Drugs

India’s Emerging Role in Immuno-Oncology Drugs

The Rising Immuno-Oncology Landscape in India

Over the past decade, immuno-oncology has revolutionized cancer treatment. While major advances have been led by large multinational pharmaceutical companies, India is now emerging as an important player in the development and production of immuno-oncology drugs. Several Indian pharmaceutical companies are developing low-cost biosimilars as well as conducting clinical trials of novel Immuno-Oncology Drugs therapies. This reflects India’s strengths in pharmaceutical manufacturing and growing expertise in biologics.

India’s biosimilar industry has grown considerably in recent years. Major players like Biocon, Dr. Reddy’s Laboratories and Intas Pharmaceuticals have received regulatory approvals for biosimilars of popular oncology drugs like bevacizumab, trastuzumab and rituximab. These companies are leveraging their experience and World Health Organization-approved manufacturing facilities to develop affordable versions of expensive immuno-oncology drugs. Recently, Biocon launched a biosimilar of pembrolizumab, the first such product to be made available in India. Wider adoption of biosimilars could increase patient access to immunotherapy and generate cost-savings for the healthcare system.

In addition to biosimilars, Indian companies are developing novel immuno-oncology therapies. Mumbai-based Natco Pharma is conducting Phase III trials of its PD-1 inhibitor nivolumab in non-small cell lung cancer and other solid tumors. New Delhi-based Emcure Pharmaceuticals has a CTLA-4 antibody bremelanotide in Phase II trials for various cancers. Dr. Reddy’s Labs too is exploring a CTLA-4 antibody. While these programs are still in early stages, they demonstrate India’s growing research capabilities and ambition to develop differentiated oncology products.

Focus on Combination Therapies

With monotherapy immuno-oncology drug approvals leveling off in major, the future of the field lies in combination regimens. Though combination trials require significant investments, they offer the potential for improved clinical outcomes. Indian companies are rising to this challenge by exploring combination strategies with their drug candidates.

Natco’s Phase III studies of nivolumab include cohorts exploring its use in combination with chemotherapy as well as targeted therapies. Emcure is evaluating bremelanotide in combination with chemotherapy, radiation and other immunotherapies. Dr. Reddy’s is planning combination studies of its CTLA-4 antibody. These combinations aim to leverage the mechanisms of various therapies to elicit stronger and more durable anti-tumor responses.

At the same time, Indian firms are expanding clinical collaborations with global pharma companies to explore innovative combinations. For example, Dr. Reddy’s has partnered with Merck KGaA to test the combination of bintrafusp alfa, an investigational bifunctional fusion protein, with both companies’ immuno-oncology drugs. Natco is working with Five Prime Therapeutics to study FRĪ± antibody fPA544 in combination with nivolumab. Such partnerships allow Indian drug developers to clinically validate promosing combination therapies and establish their scientific capabilities, which can aid further growth.

Government Support Fuels Infrastructure Development

The Government of India has recognized biologics manufacturing and clinical research as priority sectors for the country’s pharmaceutical industry. It is providing funding, land allocations and regulatory guidance to encourage local product development. Major policy initiatives driving the immuno-oncology space in India include:

– The Department of Biotechnology’s support through grants, equity funding and regulatory assistance has enabled companies to establish state-of-the-art manufacturing facilities and significantly expand clinical trial infrastructure.

– The Center has contributed funding to the Phase III studies of nivolumab, which has triggered technology transfers and skills development.

– Regulatory reforms by the Central Drugs Standard Control Organization have accelerated approval timelines for biosimilars to just over 1.5 years on average, among the best globally.

– Policy frameworks like Product Patents and Make in India are attracting global as well as domestic investments with favorable tax structures and incentives.

Such government support has propelled India into a leading position in manufacturing complex biologics like monoclonal antibodies and vaccines. Indian companies are now leveraging these expertise and assets to develop low-cost immunotherapies that could transform cancer care worldwide.

Driving Value Through Innovation

While biosimilars will continue dominating India’s immunotherapy exports, local innovators are striving to develop groundbreaking oncology products. Natco’s nivolumab and Emcure’s bremelanotide showcase this transition towards novel research. Both firms are exploring new immuno-oncology mechanisms beyond PD-1/PD-L1 and CTLA-4 pathways as well.

For example, Natco is advancing a B7-H3 antibody through preclinical stages, targeting an emerging immune checkpoint. Emcure has an experimental intratumoral lactic acid inhibitor being studied for sensitizing tumors to checkpoint blockade. Such indigenous product development aims to differentiate Indian innovators in global in the long run. It also builds diverse scientific capabilities within companies and research institutions alike.

Over the past few years, India has progressively enhanced its position in the Immuno-Oncology Drugs space. Home-grown manufacturers have successfully commercialized affordable versions of blockbuster immunotherapies. At the same time, Indian pharmaceutical firms are maturing into integrated drug developers by establishing innovative early-stage pipelines. With sustained government encouragement and growing R&D investments, India is well-placed to emerge as a leading supplier as well as innovator of next-generation cancer immunotherapies. This promises to usher in a new age of accessible and effective treatments for patients worldwide.

1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it