New information on biosimilars from Australia and the US

Biosimilars/General | Posted 04/05/2020 post-comment0 Post your comment

The Generic Biosimilar Medicines Association and the Biologics Prescriber Collaborative have released new information on biosimilars, aimed at physicians and the public, respectively.

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The Generic Biosimilar Medicines Association (GBMA) represents generic and biosimilar medicine manufacturers in Australia. In 2019, the Association launched a new educational programme on biosimilars for healthcare professionals, as well as a ‘Biosimilar Hub’ aimed at patients, prescribers and pharmacists [1].

More recently, the GBMA has released an online course on biosimilars specifically for General Practitioners (GPs). The course is accredited by the Royal Australian College of General Practitioners (RACGP) and has three key elements, summarized below:


  • How biosimilars contribute to the sustainability of the healthcare system
  • The clinical development and regulatory processes involved in approving a biosimilar

Patient care

  • Explaining biosimilars to patients
  • Managing patient concerns about biosimilars


  • Criteria that must be met to substitute a reference biological for a biosimilar

Similarly, the Biologics Prescriber Collaborative (BPC), a project of AfPA (Alliance for Patient Access), which works to ensure that policies are in place to promote the safe use of biologicals and biosimilars in the US, has released a new infographic on the US biosimilars pathway.

The biosimilars pathway is also known as the Biologics Price Competition and Innovation Act of 2019 (BPCI Act), which was passed in 2009 and created an abbreviated pathway for the approval of biosimilars in the US.

Information from the BPC shows that in the 10 years since Congress established the biosimilar pathway:

  • 26 biosimilars have been approved
  • 15 biosimilars are available on the market
  • 1,000 biosimilars are in the pipeline

The infographic also explains the five main treatment groups of approved biosimilars (oncology, haematology, gastroenterology, rheumatology and dermatology) and states that 70% of physicians are confident in the standards for biosimilar interchangeability, according to the 2018 data from the BPC.

Related articles
Biosimilars highlights: 2019

Biosimilars approved in the US

Biosimilars approved in Australia

1. GaBI Online - Generics and Biosimilars Initiative. New biosimilar guide for pharmacists in Australia []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 4]. Available from:

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Source: BPC; GBMA

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