Frequently Asked Questions

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Biosimilars are biologic medical products that are highly similar to an already approved reference biologic. They are designed to have no clinically meaningful differences in terms of safety, purity, and effectiveness. Biosimilars offer a cost-effective alternative to existing biologics, making advanced therapies more accessible.

Unlike generics, which are chemically synthesized and identical to their reference products, biosimilars are made from living cells and can only be highly similar, not identical, to their reference biologics due to the natural variability of biological manufacturing processes. Both, however, must meet rigorous regulatory standards to ensure safety and efficacy.

Omexa Biologics primarily focuses on oncology therapeutics, developing biosimilars for key cancer treatments. Our lead product, P-001, is a biosimilar for a blockbuster PD-1 inhibitor, a major immunotherapy drug used to treat several types of cancer. We are also expanding into biosimilars for autoimmune diseases and inflammatory disorders.

At Omexa, we use advanced biotechnological methods and state-of-the-art manufacturing facilities, such as our single-use bioreactors, to ensure consistent product quality. Our biosimilars undergo extensive analytical testing and clinical trials to demonstrate that they are as safe and effective as their reference biologics.

Biosimilars must undergo a rigorous approval process by regulatory agencies like the FDA (U.S.), EMA (Europe), and DCGI (India). This involves demonstrating biosimilarity through comprehensive data, including structural, functional, preclinical, and clinical studies. While the pathway is shorter than for new biologics, it still ensures that biosimilars meet stringent standards.

Biosimilars represent a growing market with the potential for significant cost savings for healthcare systems and patients. As patents for biologic therapies expire, biosimilars offer an opportunity to capture market share in established therapeutic areas. Omexa Biologics is positioned to capitalize on this growth by developing high-quality biosimilars with a focus on oncology, one of the largest sectors in biologics.

By focusing on scalable manufacturing technologies, like single-use bioreactors, Omexa can reduce production costs while maintaining flexibility. Our investment in efficient manufacturing processes ensures that we can produce biosimilars at lower costs, which translates to competitive pricing and higher margins in global markets.

Omexa combines cutting-edge science with strategic partnerships to accelerate the development and commercialization of our biosimilars. We prioritize affordability without compromising quality, ensuring that our biosimilars meet or exceed global regulatory requirements. Additionally, our focus on emerging markets allows us to reach underserved populations while driving sustainable growth.

Our lead biosimilar, Pembrolix, is expected to receive regulatory approval in India by Q1 2027, with plans for subsequent launches in other emerging markets. Our pipeline includes other key biosimilars targeting oncology and autoimmune diseases, with clinical trials and regulatory submissions scheduled over the next few years.

The global biosimilars market is rapidly expanding, driven by the expiration of biologic patents, rising healthcare costs, and increased acceptance of biosimilars among providers and patients. Oncology biosimilars, in particular, are forecasted to see strong demand due to the high cost of cancer treatments. Omexa is well-positioned to capture market share in these growing sectors.