Evaluate a list of Biosimilars for Market entry -

Evaluate a list of Biosimilars for Market entry

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Overview

Biosimilars of novel targeted molecules play a crucial role in ensuring desirable treatment outcomes with a major benefit for larger masses, particularly in developing countries like India. They greatly reduce the cost of treatment without compromising the efficacy or safety of the treatment.

As they are increasingly becoming a mainstay in oncology practices, the following case study is about enabling a major American Pharma company to acquire the right biosimilars for the Oncology division in order to provide benefit to Indian patients

Introduction

In the competitive landscape of pharmaceuticals, biosimilars represent a promising avenue for companies to expand their market reach, especially in emerging markets like India. This case study delves into how a large US pharmaceutical company, with the guidance of Atticus Healthcare, evaluated and successfully introduced biosimilars in the Indian oncology market. The goal was not only to establish a strong presence but also to provide cost-effective treatment options for patients suffering from prevalent cancers.

Problem Statement

The primary challenge faced by the US pharma company was to identify and evaluate biosimilars in oncology that would enable them to penetrate the Indian market effectively. Given the high prevalence of certain cancers in India, there was a pressing need to provide affordable and efficacious treatment options. The company’s objective was to establish a significant foothold in India by launching biosimilars that could compete with existing innovator molecules nearing patent expiry.

Approach and Methodology

Identifying Prevalent Cancers in India

The first step was to conduct thorough research to identify the most prevalent cancers in India. Using credible government and nonprofit cancer portals, the following cancers were highlighted due to their high annual incidence and five-year prevalence: Breast Cancer, Ovarian Cancer, Colorectal Cancer, Lung Cancer Cervical Cancer.
Selecting Innovator Molecules

The next phase involved identifying innovator molecules, specifically monoclonal antibodies (MABs), that demonstrated proven safety and efficacy in the Indian population and were nearing their patent expiry. From a pool of five prospective molecules, two MABs were selected based on their potential to offer significant benefits in terms of effectiveness and affordability for patients.
Conducting Desk Research and Validation

Extensive desk research was conducted to gather data on the selected molecules. This research was further validated through surveys with leading oncologists in India. The key areas of focus included: Market trends and growth potential of the molecules. Scope for indication expansion to maximize the therapeutic impact. Identifying credible manufacturers capable of producing high-quality biosimilars.
Due Diligence on Manufacturers

Due diligence was carried out to ensure that the identified manufacturers met the necessary criteria for clinical trials, operations, and site feasibility for scaling production. The clinical trial data generated was rigorously vetted to ensure that the safety and efficacy of the biosimilars were on par with the innovator drugs. All required prerequisites by the Drug Controller General of India (DCGI) were met. Market trends and growth potential of the molecules. Scope for indication expansion to maximize the therapeutic impact. Identifying credible manufacturers capable of producing high-quality biosimilars.
Validation through Advisory Board Meetings

To ensure the reliability of the gathered information, a series of advisory board meetings were conducted with leading oncologists in India. These experts provided valuable insights and validation, reinforcing the credibility of the research findings and the chosen biosimilars.

Outcomes and Results

The strategic and meticulous approach adopted by the US pharma company, guided by Atticus Healthcare, yielded significant positive outcomes:

Successful Launch of Biosimilars

Both identified biosimilars were successfully launched in succession in 2021 and 2022. These launches provided Indian cancer patients with cost-effective, safe, and effective treatment options.
Reduced Therapy Costs

The cost of therapy was significantly reduced by two-thirds compared to the innovator molecules, making treatment more accessible to a larger patient population.
Increased Drug Uptake

The affordability and efficacy of the biosimilars led to increased uptake, helping the company achieve and exceed defined sales targets. This success infused confidence in the organization to further develop its oncology division. Market trends and growth potential of the molecules. Scope for indication expansion to maximize the therapeutic impact. Identifying credible manufacturers capable of producing high-quality biosimilars.

Conclusion

The successful evaluation and launch of biosimilars in the Indian oncology market highlight the immense potential for pharmaceutical companies to make a meaningful impact in emerging markets. By leveraging thorough research, expert validation, and strategic planning, the US pharma company was able to provide affordable treatment options and establish a strong market presence. This case study underscores the critical role of biosimilars in transforming healthcare accessibility and offers a blueprint for other companies aiming to venture into similar markets.

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