Biologics & Biosimilars Position Paper

Biologics are a class of treatments derived from living cells (proteins) that target specific parts of the immune system, and are proven to effectively treat many diseases. Like other medications, the same biologic may be approved for the treatment of psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, lupus, diabetes, some forms of cancer or kidney disease.

What is a biosimilar?

Biosimilars are similar but not identical versions of an existing or original biologic medication. The exact conditions for making biologics are not made public, so while biosimilars are made by the same process as the original biologic, there may be small differences resulting in variances in the product. Differences in techniques may include the type of cells used to produce them, the temperature at which the cells are grown, the pH at which the cells are grown, and the types of nutrition provided to the cells. Unlike generics, where the active ingredient is identical to the brand name drug, biosimilars are the same protein as the originator biologic but may have some small structural changes due to differences in production. Biosimilars and biologics have the same mechanism of action, meaning that they target the same biological pathway, and should result in the same benefits and risks with treatment. Even original biologics have changed over time as small changes have been made to how they are grown from batch to batch.

In patients starting on a biosimilar, current evidence suggests that biologics and biosimilars have comparable clinical effectiveness in patients that have never tried a biologic or biosimilar previously (also known as biologic treatment-naïve). Furthermore, studies on switching have not demonstrated biosimilars to be any less effective or safe than its originator biologic.

It is the Canadian Spondyloarthritis Assocation position that:

• Biosimilars have been demonstrated to be safe and effective;
• Biosimilars play a role in providing additional treatment options for patients living with inflammatory conditions;
• Treatment choice should remain between the patient and the physician based on medical need as well as informed and shared dialogue;
• Biosimilars have a potential to lower health care costs and increase access to treatment;
• Biosimilars must have unique and distinct names, drug identification numbers and specific lot numbers;
• Patient experience on transitioning from original biologic to biosimilar should be captured in a publicly accessible registry.

Considerations for Implementation in the Canadian Healthcare System:

• Optimal patient care and safety must be the priority;
• Education and support materials should be developed, made available and disseminated to ensure patients and healthcare professionals are well informed;
• If public or private payers adopt policy that preferably support biosimilars, the patient and the patient’s rheumatologist should have the final say on choice of treatment;
• Before a patient is switched from an originator biologic to the biosimilar, an informed two-way consultation must take place between physician and patient and appropriate time and resources be provided to allow for the dialogue to occur;
• If a patient is changed to a biosimilar due to payer policy change and experiences a flare-up within a specific period of time after the change, the patient should be able to return to the originator biologic with the same level of coverage as before;
• Patients and their physicians should have access to the equivalent patient and physician support programs as those provided by originator drug programs. Key services provided by such programs include bridge funding, co-payments, needle disposals, infusion clinic accessibility and patient care co-ordinators;
• Post-market surveillance and a registry of real-world data that includes patient reported and medical outcomes should be systematically collected;
• Costs savings from the use of biosimilars should be re-invested into the enhanced care of people with arthritis. Examples include improving access to physical therapy, education, new models of care and providing biologics to more Canadians;
• Patient organizations and healthcare professionals be consulted when healthcare system and policy changes are being considered for implementation.

The Canadian Spondyloarthritis Assocation’s Role:

• The CSA will continue to prioritize patient care, access, needs and outcomes in any discussion pertaining to biologics and biosimilars;
• The CSA will continue to empower the Spondyloarthritis community with information regarding biologics and biosimilars to ensure individuals can engage in an informed discussion with their physician equipped with accurate and evidence-based information when discussing and choosing the best treatment option for the patient.
• The CSA is committed to ensuring decision makers clearly understand the impact on patients of implemented public policies.