Biologic to a Biosimilar

Biologic to a Biosimilar

From the  Canadian Digestive Health Foundation

What are biologic drugs?

Biologic drugs are large molecule medications that are manufactured using living organisms or cells. Because of their larger size these molecules tend to be more complex compared to their chemically made counterparts.Examples of biologics are vaccines, insulin, growth hormones, and monoclonal antibodies. They are used to treat a variety of diseases such as diabetes, anemia, hormone deficiencies, cancer, inflammatory bowel diseases and rheumatoid arthritis. As more benefits are found in using biologic drugs, these medications are being used to treat more and more diseases.

What are biosimilars?

Biosimilars are biologic drugs that are highly similar to the originator biologic. However, they are not exactly the same. Due to the complex manufacturing process required to create biologics, it is impossible to create an exact copy of the original product. This is also true between batches of the originator biologic; small differences may be present.

Health Canada has a separate approval process for biosimilar drugs which requires manufactures of biosimilars to demonstrate that despite these small differences there are no expected clinically meaningful differences between biosimilar and originator biologic drugs in terms of efficacy and safety.Unlike traditional small molecule drugs that are chemically created and allow for exact copies to be made, biosimilars cannot be considered generics because they are not the same and cannot be considered bioequivalent. Pharmacists cannot auto substitute a biosimilar for an originator biologic like they do for generics of brand name medications. A new prescription specifying the specific biosimilar to use must be obtained from the prescriber in order to switch to a biosimilar.

Why switch?

Real world evidence shows that switching patients from originator biologics to biosimilars is a safe and effective practice.A peer-reviewed study  found that there have been more than 178 clinical trials worldwide, involving approximately 21,000 switched patients, which confirm that switching from an originator biologic drug to a biosimilar biologic drug is not associated with any major efficacy, safety, or immunogenicity issues.

Biologic medications are expensive with many costing somewhere between $10,000 to $25,000 per patient, per year, or more! Biosimilars present drug plans with significant cost savings which can be reinvested back into the health care system to fund more medications or to provide more services and support. Many Canadian jurisdictions have already implemented biosimilar switching polices. These policies have also existed in many European countries for more than 10 years.

Tips for speaking to patients about switching

As a pharmacist you are a trusted source of patient information. As a trusted expert, you can set the tone for patient expectations and comfort when switching to a biosimilar. Treatment-experienced, stable patients using an originator biologic may need more support to help them through the switching process.

Important information patients need to know about biosimilars:

  • They are safe and effective.
    • They are well researched. The EU has successfully implemented switching programs for more than 10 years, and many provinces in Canada have done so as well with similar successes.
  • They work similarly to the current medication with no increased risk of adverse reactions.
    • Biosimilars undergo a rigorous approval process before receiving Health Canada approval.
  • Switching to biosimilars does not involve any major changes to the patient routine or dosing.
    • They are similarly dosed, however patients may need training on different self-administration devices, if applicable.
  • They are accompanied by patient support programs, if applicable.
    • Though the patient support program company will change, it is expected that patients will receive similar levels of support.

Understanding the Nocebo effect

The nocebo effect is a phenomenon in which a patient’s beliefs, attitudes, and previous experiences create a negative expectation. This often has an adverse impact on treatment success and could lead to treatment failure. It is important as pharmacists to acknowledge the nocebo effect in our patient interactions. 

To help guard against a potential nocebo effect pharmacist should:

  • acknowledge the nocebo effect,
  • be attentive and empathetic,
  • promote a neutral or positive outlook,
  • give balanced information about desired effects and adverse effects, and
  • suggest a plan for follow-up.

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