A biosimilar is a biological medicine produced using living systems that demonstrate to be highly similar to an approved reference biologic, with no clinically meaningful differences in safety, purity, or potency. Developed through an abbreviated regulatory pathway that leverages existing clinical data, biosimilars reach the market faster and at lower cost compared with originator biologics — delivering meaningful savings to patients and payers.

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.