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Biosimilars

A biosimilar medicine is a version of a biologic drug that is already authorised for sale. A biologic is also known as a reference or an originator drug. Biosimilars have no clinical difference with a reference drug, meaning that they are the same in terms of their quality, safety, and efficacy.  

Biosimilars have been treatment options in a variety of diseases for more than 10 years. In oncology, including in lymphoma treatment, patients may have received biosimilars that increase production of certain blood cells. These supportive care drugs do not treat the cancer itself but treat side effects. Relatively new to the market are rituximab biosimilars, that treat the lymphoma directly.

Even though biosimilars have been approved and used in treatment in some parts of the world, they are still not available widely or consistently to patients everywhere. It is anticipated that in the coming years, the use of biosimilars to treat lymphoma will expand considerably.


Biosimilars help address the barriers that patients can experience by increasing their access to treatment. The biosimilar version of an approved biologic drug provides an affordable treatment option, especially for those countries who have a high burden of disease and barriers that affect how patients access treatment.  

Biosimilar medicines are genetically engineered proteins that are manufactured from a living source and although they are not identical to the reference product, they still offer the same benefits. Since biosimilars are large complex molecules that are produced using live organisms, they are sensitive to manufacturing changes.  

There are cost advantages to using biosimilars to treat diseases. For instance, biosimilar drugs may be sold at lower prices. This helps to lower the cost to health systems and can help more people access treatment for their disease, including cancer, at a lower cost to healthcare. Despite evidence that biosimilars provide clinical benefit to patients, challenges in uptake persist. These are due, in part, to persistent barriers to access, lack of availability and concerns about the affordably of biosimilar medicines. 

Increasing understanding of biosimilars in a clinical setting is strengthen by the availability of data, including patient experience and real-world evidence. Patient experience data and updated registry data can increase understanding about biosimilars amongst clinicians and patients. It can also provide information to help address and dispel misconceptions, encourage good communication and support shared decision-making. 

As biosimilars become more prominent in prescribing practices, building patient confidence and trust in biosimilars is crucial. This helps avoid confusion and support shared decision-making between clinicians and patients.   

Building confidence in biosimilars can help dispel any common misconceptions that people may have, including the mistaken belief that biosimilars are of lower quality or that they have reduced efficacy in comparison to the reference biologic drug.    

Biosimilar medicines bring costs savings to health systems. Early adoption of biosimilar medicines is expanding patient access to treatment. 

Health systems that prioritise patient access can support biosimilar uptake, improve medicine availability, and address issues around affordability.  

In a clinical setting, it is important that clinicians and patients are aware of biosimilars as a possible treatment option. Also, if patients are switched from a drug to a biosimilar medicine, it should be done in consultation to help ensure that

patients understand biosimilar safety and efficacy.   Using plain language information about biosimilars supports good communication between patients and healthcare professionals. It helps increase biosimilar awareness and support informed choices or decision-making

Biosimilars can improve change the treatment landscape for patients by increasing awareness of biosimilar medicines in clinical settings. 

Patient experience data and updated registry data helps inform policy decision-makers, as well as increase understanding about biosimilars amongst clinicians. 

Access to medicines and the cost of therapies are further deepening global inequities. Biosimilar medicines increase access and treatment options, bring cost savings to health systems, and provide evidence-based clinical benefit to patients.

This resource provides a concise overview of biosimilar medicines and their role in transforming treatment options for patients. It outlines how biosimilars can improve equitable access to medicines, support affordability within health systems, and expand therapeutic options without clinical difference in quality, safety, or efficacy compared to a reference drug.


Whether used to inform policy discussions, support shared decision-making, or strengthen advocacy efforts, this document offers a clear and practical reference to guide conversations around access, availability and affordability of oncology medicines.