Biological and biosimilar medicines

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Biological medicines

Biological medicines are a type of medicines that are made from living organisms, such as a yeast, bacteria or animal cell. Biological medicines are an important part of modern health care. They include familiar products like vaccines and insulin to treat diabetes. Biological medicines are used to treat conditions such as:

  • cancer
  • arthritis
  • auto-immune disorders.

What is different about biological medicines?

Biological medicines tend to be large, complex molecules. They cannot be made by a chemical process (like most medicines) but need to be made from a living organism.

Because biological medicines are made from living organisms, they vary naturally. This creates small differences between batches of the same biological medicine.

There are limits set on these differences to make sure they do not change the medicine’s safety or effectiveness.

Patients taking biological medicines often require careful monitoring

All medicines have the potential to cause adverse reactions. However, biological medicines are more likely to cause an allergic-type reaction because they are larger molecules.

People on biological medicines need to be monitored carefully for these types of reactions.

Biosimilar medicines

A biosimilar medicine is a very similar version of a biological medicine (the original medicine is usually called the reference medicine). Small differences occur because the molecules in these medicines are large, complex, and from living organisms. These differences are similar to the differences that can occur between batches of a reference biological medicine.

Despite these small differences, biosimilar medicines are expected to be as safe and effective as the reference biological medicine.

Biosimilars are usually made by a different pharmaceutical company and have a different ‘brand name’ to the reference medicine. A biosimilar medicine can only be marketed once the patent on the reference biological medicine has expired.

How do we know the biosimilar medicine works?

Biosimilar medicines must undergo extensive quality and clinical testing to show they are as safe and effective as the original. However, they don't have to go through quite as many trials as the original.

Biosimilar medicines are manufactured following strict quality requirements, using state-of-the-art methods. Every facility making medicines is audited to ensure it’s following Good Manufacturing Practice.

The value of biosimilar medicines

Biosimilar medicines help Pharmac give patients better access to important treatments. Biosimilars reduce costs for the New Zealand health care system in two main ways:

  • They cost less to make than the reference medicine because they don’t need as many clinical studies. They build on the existing scientific knowledge of the medicine.
  • They compete with the reference medicine. This can help to push down the price of the medicine too.

Medsafe approves biosimilar medicines

Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, approves medicines used in New Zealand.

To ensure the biosimilar works and is safe, Medsafe examines:

  • the information about the quality of the biosimilar
  • evidence of how the biosimilar was developed
  • how patients have responded to the biosimilar.

All data the company provides about safety and effectiveness must meet international standards.

Find out more about the Medsafe evaluation and approval process – Medsafe website(external link)

Medsafe recommends that prescribers make the decision to switch biosimilar medicines. Any decision should be made with agreement from the patient.

Read Medsafe’s position statement on biosimilar medicines – Medsafe website(external link)

Biosimilar medicines are global

Biosimilar medicines have been widely used overseas since 2006. In New Zealand, biosimilar medicines have been funded by Pharmac since 2012.

Over this time, both local and international clinical experience has shown that biosimilar medicines are safe and effective.

More information

Your health care team is a great place to ask for information on your medicine. Talk to your doctor, nurse or pharmacist.

New Zealand specific information about biologics and biosimilars – Health Navigator website(external link)