Australia's PBAC backs Enbrel biosimilar Brenzys

Australia’s Pharmaceutical Benefits Scheme Committee has recommended the listing of Brenzys as a biosimilar of originator brand etanercept (Enbrel) on a cost minimization basis with Enbrel for all adult indications – rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and chronic plaque psoriasis.

The PBAC considered that the evidence presented in the submission supported the claims of comparative safety and effectiveness of Brenzys, from Merck & Co (NYSE: MRK) and South Korea’s Samsung Bioepis, and Enbrel, which is marketed by Pfizer (NYSE: PFE). The Samsung Bioepis biosimilar was approved in Europe in January under the brand name Benepali.

The PBAC advised the Minister that it considered the Enbrel and Brenzys brands of etanercept could be marked as equivalent in the Schedule of Pharmaceutical Benefits (‘a’ flagged), for the purposes of substitution by the pharmacist at the point of dispensing for all the circumstances (restrictions) that both brands are listed against. The PBAC noted that the substitution process allows for patient and prescriber choice and is not automatic. For any individual prescription, a prescriber may choose to not permit brand substitution. If substitution has been permitted by the prescriber, the patient may choose which brand they wish to receive from the pharmacist.