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.

 

Changes To The Manufacturing Process

After any product has been approved by the regulatory authorities, it is quite common for further changes to be made in the manufacturing process, such as7:

  • Upscaling the process
  • Yield improvement
  • New purification methods
  • Change of cell line
  • Change of manufacturing site

As these changes are introduced during the life-cycle of the product, the quality, safety and efficacy of the product post-change must be proven to be comparable to that of the product pre-change. As a general scientific principle, comparability does not necessarily require the products pre and post-change to be identical, instead, comparability within certain parameters needs to be verified5.

This same general scientific principle of comparability is used in the development and assessment of biosimilars, which must have comparable quality, efficacy, and safety to the reference biologic medicine8,9.