Posted 31 May 2017
Biosimilar versions of Roche's Avastin and Herceptin could hit Australia in the next 12 months, threatening $272 million of the company's pre-rebate R/PBS income.
The two blockbusters have so far escaped the biosimilar onslaught experienced by sister therapy Mabthera but biosimilar sponsors such as Spanish company mAbxience are looming with competitors in hand.
In a recent release on a US deal mAbxience revealed it had already "established partnerships in Europe and Australia for its [Avastin] biosimilar".
Meanwhile Amgen has become the first company to have an Avastin biosim, Mvasi, approved in the EU and US. Although the company has made no reference to pursuing a similar approval in Australia, it has already been down the regulatory path here with Humira copy Amgevita, approved last November.
Meanwhile, a statement released last December on the approval of Biocon and Mylan's Herceptin copy in Brazil said the drug was already "under review by regulatory authorities in Australia", suggesting a registration, if successful, may be made by December.
Biocon and Mylan have emerged has big players in the biosimilar space locally after their copy of Lantus biosimilar Semglee was added to the July PBAC agenda a month after its March ARTG registration. The two companies' joint portfolio also has an Avastin copy in the works.
In the 12 months to March, Avastin made $85.7 million in pre-rebate R/PBS benefits, while Herceptin made $186.4 million. Together the two cancer drugs make up almost half of Roche's total pre-rebate R/PBS benefits.
With the addition of Mabthera's $131.6 million in benefits, the company faces a biosimilar wave targeting almost 70 per cent of its total revenue.
However Roche has also made attempts at shoring up its portfolio with innovative therapies, bringing three new major therapies onto the PBS in the first half of this year: Ocrevus, Alecensa, and Tecentriq.
Yajun Ma