Is there a difference in health outcomes between the biosimilar medicine and the reference biological medicine?

Page last updated: 23 March 2017

No. A biosimilar medicine has been tested and shown to be as safe and effective as the reference biological medicine, and either can be used to treat the disease. The minor differences between reference and biosimilar medicines do not affect the safety or effectiveness of the biosimilar medicine.

There is no difference in the quality of biological and biosimilar medicines. The manufacturing process for a biosimilar medicine must comply with the same quality requirements for any biological medicine and must demonstrate that the production process can consistently produce a high-quality product.

In 2016, the School of Pharmacy and Medical Sciences at the University of South Australia looked at the recent research that had been published about biosimilar medicines. The review summarised evidence which proved that biosimilar medicines were as safe and effective, and of the same quality, as the reference biological medicines.

Questions commonly asked about the safety, effectiveness and quality of biosimilar medicines
Question Answer
Is there a higher risk of side effects with biosimilar medicines compared with the reference biological medicines? No. The incidence of side effects (i.e. the number of people who experience side effects) is the same for biosimilar medicines as for biological medicines. For a biosimilar medicine to be approved for use in Australia, it must show that the incidence and severity of side effects are no greater than for the reference biological medicine.
Is there a higher risk of an allergic reaction with a biosimilar medicine compared with the reference biological medicine? (known as immunogenicity) No. The incidence of allergic reactions (i.e. the number of people who experience allergic reactions) for biosimilar medicines is no greater than for the reference biological medicine.  Such reactions are monitored by the Therapeutic Goods Administration (TGA).
Can a biosimilar medicine be used to treat all the same conditions as the reference biological medicine? (known as indication extrapolation)

The TGA decides whether the biosimilar medicine will be registered to treat all the same conditions as the reference biological medicine.

This decision is based on sound scientific principles and guidelines from the European Medicines Agency.
Will switching between reference and biosimilar medicines lead to different health outcomes? No. Biosimilar medicines have been demonstrated to provide the same health outcomes as the reference biological medicine. International research has found no difference in outcomes with switching from reference biological medicines to biosimilar medicines.
Who monitors whether the medicine is still safe and effective once it reaches the market? (known as pharmacovigilance)

The TGA monitors the safety of biosimilar medicines once they reach the market, and also relies on the public, health professionals and industry to report problems with medicines. If the TGA finds that there may be a risk to patients from a medicine, it can require changes to product labelling or use, or take the medicine off the market.

How are the differences in the medicines monitored? The TGA monitors biological and biosimilar medicines to ensure that the variability of the molecules is within the established acceptable ranges.

The number and type of adverse effects and side effects are the same for biosimilar medicines as for the reference biological medicines. In the European Union, no significant problems relating to adverse events have been discovered with biosimilar medicines since their introduction in 2006.[1]


[1]  Pasina L et al . Biological agents and biosimilars: Essential information for the internist. European Journal of Internal Medicine 2016- 33:28-35.

If you are already taking a biological medicine, you and your doctor can choose to switch your treatment to a biosimilar medicine. Recent postmarket research has found no differences in health outcomes between patients who switched medicines and patients who remained on the reference biological medicine.

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