BIOSIMILARS MARKET ANALYSIS

The expiry of patents and data exclusivity protection of major blockbuster biologics can offer significant opportunities for biosimilar manufacturers. As patents expire in therapeutic areas such as oncology, immunology, endocrinology and ophthalmology, biosimilar manufacturers will be able to develop biosimilar versions of top-selling biologics. This will provide more treatment options to patients, as well as potential cost savings to healthcare systems globally. Many biosimilar developers are actively working on expanding into new therapeutic indications beyond just oncology, where most biosimilars are currently concentrated. For example, in 2022, the World Health Organization’s essential medicines list added several newly off-patent biologics used for diabetes and Non-communicable lung diseases. This prioritization highlights growing global burden of diseases that could potentially be treated more affordably with biosimilars. Some manufacturers have also announced pipeline biosimilars in development for auto-immune disorders such as rheumatoid arthritis. Successful approvals and launches in diverse therapeutic areas would provide opportunities to achieve blockbuster revenues for certain biosimilar products.

Market Opportunities: Potential entry of biosimilars into new therapeutic areas

Global biosimilars market has traditionally been dominated by a small number of therapeutic areas such as oncology, hematology and immunology. However, as several blockbuster biologics are nearing patent expiry in disease areas such as diabetes, autoimmune disorders and ophthalmology, this provides a massive opportunity for biosimilar manufacturers to enter new therapeutic segments. As per the World Health Organization, over 422 million people worldwide had diabetes in 2014, showing a significant patient population available for affordable biosimilar treatment options.

As biosimilar companies gain more experience and success in demonstrating interchangeability in areas like oncology through post-marketing studies, it will give them more confidence to invest in biosimilar development for other complex disease classes and expand their portfolio. This will allow more patients access to important biologics that were previously financially out of reach for treatment. For example, the approval of the first interchangeable biosimilar insulin product in the U.S. in 2023, demonstrated that biosimilars can successfully compete even in therapeutic areas like diabetes that require a cold chain and are administered by patients themselves. The entry of multiple biosimilar competitors can considerablylower drug prices, providing both healthcare systems and patients with significant savings. These savings could then be redistributed to expand access to other novel therapies. This makes the potential for biosimilars in new disease areas an extremely valuable opportunity to make biologics truly affordable and sustainable for patients as well as governments globally.