Immunogenicity, the ability of a substance to provoke an immune response23, was a key concern of regulators and healthcare professionals when the first biosimilars were approved over a decade ago. Verifying that the proposed biosimilar and reference product have comparable immunogenicity profiles, via a head-to-head comparison, is a critical component in defining the safety profile of the biosimilar and its overall similarity to the reference product1,4. Data collected through both post launch monitoring and clinical trials has not validated these original concerns and the incidence of immunogenicity for biosimilar medicines has been shown to be no higher than for the reference product21,24.
At Juno, our goal is twofold: increase patient access to high quality, lifesaving medicines and increase value within the Australian healthcare system.
Biosimilars and interchangeable biologic products present an opportunity to patients, healthcare professionals and the government, by providing increased patient access to therapies, whilst helping maintain the long-term viability and financial sustainability of the Australian and New Zealand healthcare systems.
We believe that we have the right expertise and strategies to effectively partner with biologic developers whose brands are reaching their patent expiry, plus biosimilar developers with plans to launch in Australia and New Zealand.
Immunogenicity
