Australia's GBMA Launches Hub for Biosimilar Education

The Generic Biosimilar Medicines Association (GBMA), which represents generic and biosimilar drug developers in Australia, has launched an educational portal aimed providing information on biosimilars to prescribers, pharmacists, and patients.

In 2018, GBMA was awarded the Biosimilar Education Grant by the Australian government to develop an educational program for Australian stakeholders with the aim of increasing confidence in biosimilars that are listed on the nation’s public drug benefit plan, the Pharmaceutical Benefits Scheme (PBS).

The prescriber section of the educational portal includes a comprehensive brochure that explains the development process for biosimilars; pharmacovigilance for these products; and "a-flagging" of medicines, which is a determination of therapeutic equivalence that allows a biosimilar to be substituted at the pharmacy level for its reference following patient consultation. It also provides samples of letters that can be sent to patients to notify them that they may be switched to a biosimilar.

The pharmacist section describes how a-flagged biosimilars may be substituted at the point of dispensing, and explains that pharmacists should discuss brand substitution with prescribers to maintain and improve professional relationships and avoid any misunderstandings.

Pharmacists should also educate their patients, said GBMA, saying that patients may be encouraged to keep or photograph their drug’s packaging to enable them to keep track of brand and batch numbers for their future healthcare interactions.

Patient and caregiver information provided in the portal includes details about about the kinds of diseases that biosimilars are approved to treat, and explains the difference between biosimilars and generics. It provides an outline of the regulatory process for biosimilars, and contains a question-and-answer section that discusses safety, efficacy, and quality of these therapies.

Among the key communications of the portal is the fact that Australia’s statutory price reduction of 25% applies to all brands of a medicine after the first generic or biosimilar product is listed on the PBS. Savings generated through the use of biosimilars, driven in part by this mandatory discount, can be reinvested into other aspects of the healthcare system, explains GBMA, leading to expanded access, funding for new treatments, and a larger range of subsidized therapies available through the PBS’ national system.

The portal also includes quarterly literature reviews that contain abstracts of studies related to biosimilars, specifically in reference to substitution and the extrapolation of indications. Other studies covered include those related to health outcomes, current perceptions, and uptake initiatives. A repository of videos with thought leaders in various medical specialties, an interactive educational section with quizzes, and a listing of events are also provided.

This educational effort marks another step in Australia’s concerted effort to realize biosimilars’ savings potential. Among its efforts has been the implementation of what it terms “uptake drivers” as a matter of national policy: encouraging prescribing of biosimilars over branded drugs for new patients, and providing a faster and simpler preapproval process for patients to receive a biosimilar drug than a branded drug. The drivers, says the government, are expected to be time-limited initiatives that will support the acceptance these products and positively impact market behavior.

The first product to become subject to the uptake drivers was etanercept in December 2017, followed by follitropin alfa in 2018 and infliximab in 2019. The government also published fact sheets on the biosimilars, with separate documents made available to prescribers, pharmacists, and patients or their caregivers, as part of the initiative.