Australia's PBAC Recommends 2 Adalimumab Biosimilars for Pharmacy-Level Substitution

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that 2 adalimumab biosimilars be treated as equivalent to the reference adalimumab, Humira, and be subject to substitution at the pharmacy level.

The products, Amgen’s Amgevita and Samsung Bioepis’ Hadlima, will be “a-flagged,” or given a listing that allows them to be substituted for Humira—or for one another—by a pharmacist for the indications that they share, although the prescribing physician retains the right to prevent substitution by requiring a prescription to be dispensed as written.

Read more about biosimilars in Australia.

In the case of Amgevita, which is approved for all indications of the reference product, a pharmacist could substitute Amgevita for Humira or Hadlima. In the case of Hadlima, which is only approved to treat rheumatoid arthritis (RA), Hadlima could be substituted by the pharmacist for either Humira or Amgevita to treat RA only.

Furthermore, the PBAC recommended that Australia’s “uptake drivers” be applied to adalimumab in the same way that they have been applied to etanercept and infliximab. The uptake drivers are policies that encouraging prescribing of biosimilars over branded drugs for new patients and that provide a faster and simpler preapproval process for patients to receive a biosimilar drug than a branded drug.

As part of the uptake driver process, the Australian government publishes fact sheets on the biosimilars, with separate documents made available to prescribers, pharmacists, and patients or their caregivers.

Australia’s approach to promoting biosimilar uptake through “a-flagging” biosimilars for substitution stands in contrast to the strategies used in the United States and Europe. In the United States, pharmacy-level substitution will only be permissible by law for products that gain the FDA’s designation of interchangeability (final guidance on which is yet to be published), and rules governing substitution will vary among US states according to local laws. In Europe, pharmacy-level substitution is, for the most part, forbidden; Estonia, France, Latvia, Poland, and Russia are notable exceptions.