A biosimilar is a biological product that is similar to an approved biologic (reference product) and is produced using living systems. While complex to develop, biosimilars follow an abbreviated regulatory pathway, resulting in reduced development time and cost compared to original biologics. Thus, priced lower than the reference product.

Biologic medicines offer important treatment options for life-threatening and disabling diseases. Biosimilars are biologic medicines that have been deemed to be highly similar in quality, safety, and effectiveness to an existing biologic reference product, with no clinically meaningful differences from the original product. By introducing competition into the biologic market, where there are few low-cost alternatives, biosimilars can contribute to increased and more affordable treatment options for patients. [1]

The introduction of biosimilars in Europe has resulted in the increased use of biologic drugs in the EU by as much as 100%. [2] We anticipate increased usage in the U.S. as more biosimilars become commercially available.

Biosimilars offer a more affordable option for health systems, insurers, and patients, allowing greater access to biologics, which often cost over $100,000 per patient per year. Due to their high cost, many people, particularly in low- and middle-income countries, cannot access these advanced treatments. In Brazil and Mexico, about 40% of patients eligible for biologics do not receive them. [3,4] While biologics lead in medical innovation, biosimilars offer a cost-effective path forward for public health budgets and healthcare systems. By reducing treatment costs, biosimilars can make healthcare more sustainable and release funds for other innovative treatments. This approach not only provides wider access to affordable biologics but also supports the ongoing development of new biotechnologies.

Biosimilars are priced at substantial discounts versus the innovator biologic products and are expected to provide cost savings of up to $150 billion in the U.S. alone by 2026. [5,6]

Our R&D approach is predicated on leveraging our unique and highly refined capability set to develop highly complex medicines, regardless of regulatory pathway. While our primary focus is on biosimilars, we selectively utilize the ANDA and 505(b)(2) pathways to best serve unmet patient needs in conjunction with a disciplined approach to risk management and IP strategy.