Biosimilars are designed to be highly similar to the originator biologic in terms of efficacy, safety, and quality. Switching from an originator to a biosimilar medicine is common practice and is considered safe and effective.
Substitution and switching will not impact safety and efficacy
- Substitution is recommended by the PBAC only after the TGA has determined that a medicine is comparable to the reference medicine. Both determinations are reliant on the government authorities evaluating a comprehensive portfolio of data and providing a recommendation on whether the biosimilar is similar enough to the original biologic.
- Current reporting has not identified a different rate or type of adverse events (AE) being reported for biosimilars
Australia’s robust regulatory framework supports biosimilar market entry and patient access to life changing medicines
- Australia has a robust policy and regulatory framework, which ensures the quality, safety and efficacy of all medicines, including generic and biosimilar medicines
- Based on the recommendations of the TGA, the PBAC and Minister can recommend listing of biosimilars, utilising the demonstrated and accepted standard of equivalence
There is no evidence that ‘switching’ increases immunogenicity over time or reduces treatment efficacy
- The scientific principles for establishing biosimilarity are the same as those for demonstrating comparability after a change in the manufacturing process of an original biological brand. Such changes occur frequently and must be approved by regulators, so that the product is equally safe and effective.
- Immunogenicity is a known risk for all biologics.
- The evaluation of comparable immunogenicity is a key element for regulators (US, EU, Japan, Australia and Canada) in their assessment of a biosimilar candidate prior to approval.
- Each individual batch of a biologic and biosimilar displays what is called microheterogeneity, which are small variations in the composition of the molecule. As such, patients continuing treatment on an originator biologic have the potential risk of inducing immunogenicity as the products slightly differ from one batch to another.
- The overarching scientific understanding of inter-batch microheterogeneity is that the potential of immunogenicity in switching from an originator to a biosimilar is agreed to be no more or no less than using different batches of the same drug over time.
- In Australia, GCSF and EPO biosimilars have been successfully used since 2011 with over 1.5m patient days experience.
- GCSF is used per cycle for 5-10 days at a time with patients receiving multiple cycles and on-going chemotherapy when 1st line treatment fails. There are over 400 million patient days experience globally with GCSF biosimilars with no immunogenicity safety concerns. Data shows neutralizing antibodies aren’t common and, if detected, do not alter efficacy.
- Dialysis patients receive EPOs for many years and there is a huge amount of data showing this and also showing that immunogenicity does not increase over time. Data, as well as 400 million patient days experience globally with biosimilar EPO shows identical (or slightly less) issues with EPO immunogenicity in terms of PCRA and therefore treatment failure, as well as demonstrating the immunogenicity does not increase over time.