About Biologic Medicines

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.

 

What Is The Difference Between A Generic And A Biosimilar?

While biosimilars and generics have some conceptual parallels, the complexity of biologic medicines means that the principles relevant to the evaluation and use of generic medicines cannot be simply extrapolated to biosimilars10.

Biosimilars and generics are both alternative versions of branded, originator medicines for whom marketing exclusivity rights have expired. They are also both approved through abbreviated pathways that do not require duplicating full clinical trials11.

However, as generic medicines are comprised of small, chemical molecules, demonstration of bioequivalence between a generic and reference product is generally sufficient to infer therapeutic equivalence between the two12. Due to the complexity and inherent structural variability of reference biologics and biosimilars, the method established for generic medicines is not suitable for the development and evaluation of biosimilars12.

 

 

 

Summary of Similarities and Differences