Regulatory framework


Since the first approval of a biosimilar medicine in the EU in 2006, more than a decade of international real-world experience and associated post-marketing data has found no difference in the safety or health outcomes of patients using a biosimilar medicine and its reference products.1-3

In Australia, the TGA has adopted the EMA guidelines for the evaluation of biosimilar medicines, and approved its first biosimilar medicine in 2010.1,4-6

The information required in a biosimilar medicine application for Australian regulatory approval often involves case-by-case tailoring, so that product-specific characteristics identified through experience with the reference biological medicine are considered and compared appropriately.4,7

As with all TGA-approved therapies, biosimilar medicines must comply with post-registration pharmacovigilance requirements. This can include a Risk Management Plan (RMP) and Periodic Safety Update Reports (PSURs).4,7,8

These processes ensure safety, effectiveness and immunogenicity characteristics of biosimilar medicines are monitored long after market approval, perpetually expanding data and understanding, including how they compare to their originator products.2,4


  1. Cohen H, Beydoun D, Chien D et al. Adv Ther 2016;33(12):2160-2172.
  2. Dörner T, Strand V, Cornes P et al. Ann Rheum Dis 2016;75(6):974-982.
  3. Krendyukov A, Schiestl M. ESMO Open. 2018;3:e000319. Doi:10.1136/esmoopen-2017-000319. Accessed on: 27 August 2018.
  4. Australian Government – Department of Health. Biosimilar medicines: the basics for health care professionals. P11756. Updated: March 2017. Available at: biosimilar-awareness-initiative/$File/Biosimilar-medicines-the-basics-for-healthcare-professionals-Brochure.pdf Accessed 27 August 2018
  5. Australian Government – Department Health. How have biosimilar medicines been used around the world? Updated 7 December 2016. Available at Accessed 28 August 2018.
  6. Power DA. GaBO J 2013;2(3):152-154.
  7. Therapeutic Goods Administration. Biosimilar medicines regulation, Version 2.2. Accessed from: .au/publication/biosimilar-medicines-regulation. Updated: April 2018. Accessed on: 27 August 2018.
  8. Australian Government – Department of Health. Biovigilance responsibilities of sponsors of biologicals – Australian requirements and recommendations. Version 1.0. Updated: December 2017. Available at: Accessed 16 January 2019.