Biosimilars: The Future of Biologic Therapy

Abstract

Chronic diseases are continuing to rise globally, emphasizing the need for patients to have access to safe and effective treatments. Biologics represent a unique and powerful class of medications that have significantly changed how doctors manage conditions like cancer, diabetes, and autoimmune diseases. These treatments have led to outstanding patient outcomes—for example, biologics have halved the mortality rate for non-Hodgkin’s lymphoma. Presently, there are over 200 biologics and vaccines available worldwide, most of which are therapeutic proteins—lab-engineered proteins used in medicine, with insulin being the first developed. The field is expanding rapidly, with more than 900 biotechnology medicines and vaccines currently under development.Unlike traditional “small-molecule” drugs such as Aspirin, biologics are much more complex. They are derived from living organisms and cannot be produced solely through chemical synthesis. These drugs go by various terms including biologics, biologic therapies, biologic agents, BRMs (biological response modifiers), or immunotherapies. Biosimilars, also known as follow-on biologics or subsequent entry biologics, are highly similar versions of original biologic medicines that have lost their patent exclusivity. They offer more affordable treatment options and can stimulate competition in the biologic drug market. The original biologic is typically referred to as the reference, originator, or innovator product. A biosimilar must prove it has no clinically significant differences from its reference product in terms of safety, purity, and effectiveness. While they usually share the same primary structure and most molecular traits, slight variations in non-active components mayoccur.It’s important not to confuse biosimilars with generic drugs. Generics are exact chemical copies of brand-name drugs, identical in active ingredients, dosage, strength, route of administration, and performance—they are “bioequivalent.” Biosimilars, on the other hand, are “highly similar,” not identical, due to being made from living cells—this distinction is crucial.Modern biologic drugs have shown they can significantly improve patient health, but access remains limited—mainly due to high costs. As many well-known biologics are approaching the end of their patent and exclusivity periods, biosimilars are becoming a promising alternative. These treatments are especially appealing because they are generally more affordable, which can enhance access and offer broader benefits to patients, healthcare providers, and the healthcare system as a whole.

Introduction

Biosimilars are drugs highly similar to an FDA-approved biologic (reference biologic) in terms of quality, safety, and efficacy, as defined by agencies like CDSCO (India), EMA (Europe), FDA (U.S.), and WHO. They are developed through comparable biotechnological methods and offer similar therapeutic benefits but at a lower cost, improving access to advanced treatments.

Biologics are complex medicines derived from living cells using technologies like recombinant DNA and antibody engineering. They treat serious conditions such as cancer, autoimmune diseases, and hormonal imbalances but are often expensive, limiting accessibility, especially in developing countries.

Unlike simple generic drugs, biosimilars have complex structures and require extensive research and rigorous regulatory approval processes, including clinical trials demonstrating safety and efficacy comparable to the original biologic. India, an early adopter of biosimilar development, has established detailed guidelines through agencies like CDSCO and DBT to regulate this sector, which is growing rapidly due to patent expirations and increasing market demand.

The approval process involves pre-IND meetings, investigational new drug submissions, clinical trials, regulatory reviews, and post-marketing surveillance to ensure ongoing safety and effectiveness. Manufacturing must follow strict quality standards.

Biosimilars face challenges related to safety, substitution, naming, and labeling but play a crucial role in making biologic treatments more affordable and accessible globally.

Therapeutic uses of biologics and biosimilars include managing diabetes (insulin), vaccines, cancer treatment (monoclonal antibodies, immunotherapies), autoimmune diseases, and blood disorders.

In summary, biosimilars represent a critical advancement in biologic drug availability, requiring careful development and regulation to ensure they match the efficacy and safety of their reference products while improving treatment accessibility and reducing costs.

Conclusion

Biosimilars offer significant promise in enhancing patient accessibility to effective treatments for both malignant and nonmalignant conditions by substantially lowering therapy costs. Since the introduction of the first biosimilar, the development and application of these “similar biologics” have expanded rapidly. Regulatory agencies across the globe are increasingly approving biosimilars for a broad spectrum of cancerous and noncancerous diseases each year. India has emerged as a prominent global hub for the development and manufacturing of biosimilars. With a large and growing population, the country also represents a vast market for these cost-effective therapies. However, despite the tremendous potential and high expectations, India faces considerable challenges in sustaining its leadership position. To fully realize this potential and continue as a global leader, Indian biopharmaceutical companies must invest in technological advancements and workforce upskilling. Achieving these goals will require a supportive ecosystem, including proactive engagement and facilitation from government bodies and regulatory authorities.

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Copyright © 2025 Patil Prasad S., Vadnere Asmita G.. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.