Eye on Pharma: Mylan and Biocon Launch Biosimilar Trastuzumab, Ogivri, in Australia

Mylan and Biocon announced this week that they have launched their biosimilar trastuzumab, Ogivri, in Australia. Ogivri, referencing Herceptin, is the first trastuzumab biosimilar to launch in the Australian marketplace and is listed on the nation’s Pharmaceutical Benefit Scheme (PBS).

Sylvain Vigneault, Mylan’s Australia country manager, said in a statement announcing the launch, “As a global leader in the development of complex products, including biosimilar medicines, we’re pleased to launch our first biosimilar in Australia.” Vigneault added, “Biosimilars increase timely and affordable patient access to the latest treatments and help deliver a sustainable PBS. Mylan’s investment in biosimilars is an exciting evolution in how we can treat Australian patients. We are delighted that Ogivri enables Mylan, with our partner Biocon, to bring this treatment option to Australian patients with HER2-positive breast and gastric cancers.”

While the biosimilar is listed on the PBS and is therefore subsidized by the government, the product is not currently “a-flagged,” or substitutable at the pharmacy level. Australia’s “a-flag” system allows a biosimilar and a reference product to be substituted for one another by a pharmacist for indications that they share, although prescribers retain the right to prevent substitution. To date, only biosimilars that treat inflammatory diseases (2 infliximab biosimilars and an etanercept biosimilar) are “a-flagged.”

Also approved (but not yet launched) in Australia are biosimilar trastuzumab products developed by Celltrion (registered under the names Simbatra, Herzuma, and Hertuzu), Samsung Bioepis (registered under the name Ontruzant), and Amgen (registered under the name Kanjinti).

Ogivri is also approved in the United States, although it has yet to launch. To date, in the US context, only Amgen’s Kanjinti competes with the reference Herceptin.