Biosimilars are highly similar versions of an existing FDA-approved biologic drug (also known as the ‘reference product’) which have no clinically meaningful differences in terms of quality, clinical efficacy and safety.⁴The introduction of biologics has revolutionized treatment of a variety of chronic and lifethreatening conditions, including cancers and autoimmune diseases.⁵ However, the high cost of their development and manufacture can restrict access to treatment in both developing and developed countries alike.⁵ Fortunately, biosimilars provide a solution: a lower-cost treatment option from which patients can expect the same safety and efficacy as from the reference product.⁶

Unlike generic versions of small molecule drugs, biologics cannot be exactly replicated due to their large size and structural complexity.^4,7 (Even reference products cannot be exactly replicated batch-to-batch.) Instead, a manufacturing process is designed and closely monitored to produce biosimilars which demonstrate high structural and functional similarity to the reference product.^5,6,8

Biosimilars, like their reference products, are used in many different therapy areas including cancer and a number of autoimmune diseases. Fresenius Kabi is currently developing biosimilar medicines for use in oncology and immunology.

Patients can be initiated directly on to a biosimilar drug as the stringent FDA approval process ensures that they pose no additional efficacy or safety concerns compared to the reference product.⁹

Patients who are already receiving a different biologic treatment can also be changed or ‘switched’ to a biosimilar – learn more about this process here.

Biosimilars create a lower-cost treatment option, broadening patient access and potentially
allowing patients to initiate biologic therapy at earlier stages in the treatment cycle.⁶

Through promoting health care cost savings, biosimilars may aid in reallocating resources to other areas of the health care system.⁵ Just 2% of people in the U.S. use biologics, but they still make up 40% of total prescription drug spending.¹⁰ Biosimilars may therefore enable physicians to adhere more closely to clinical treatment guidelines and allow payer reimbursement of innovative medicines.^6,7

The amount of money spent on biologic medicines has been getting higher, with an over 50% increase in U.S. spending between 2014 and 2018.¹¹

Biosimilars introduce market competition, not only with reference biologics but also with other biosimilars, encouraging manufacturers to offer further discounts to capture greater market share.⁵ It is estimated that biosimilars can offer up to 30% price reductions when compared with reference biologics: price reductions of up to 27% for oncology biosimilars have already been observed shortly after market entry.⁶

Thanks to biosimilars, direct spending on biologic drugs in the U.S. is estimated to drop by $54 billion between 2017 and 2026.¹² Through increasing competition in the biologic market, biosimilars may not only reduce health care system costs, but also foster more patient-centered innovations by pharmaceutical companies, such as the development of new formulations or injection devices, more convenient administration routes or approaches to help with adherence.¹³

To obtain FDA regulatory approval, biosimilars must demonstrate high structural and functional similarity to the reference product.⁸ Extensive comparator studies encompassing analytical, non-clinical and clinical studies, assess toxicity, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of both biosimilar and reference product.⁸ Only minor differences in clinically inactive components are tolerated.⁸

Health care providers and patients can therefore expect the same efficacy and safety from a biosimilar as they can from the reference product.⁶ Following approval, the biosimilar must also undergo any additional specific safety monitoring required for the reference product.⁶

To learn more, visit: https://www.fda.gov/drugs/therapeutic-biologics-applicationsbla/biosimilars