FDA Approves First Cancer Biosimilar – but That Doesn’t Mean It Will Be Available to Patients Anytime Soon

29th September 2017 (Last Updated September 29th, 2017 14:56)

The FDA has approved the first biosimilar to blockbuster cancer therapy Avastin (bevacizumab). But with only three out of the current seven FDA-approved biosimilars available for sale, patients may be waiting a long time for this cost-saving therapy.

In September 2017, the FDA created an historical moment by approving Amgen’s Mvasi (bevacizumab-awwb), a biosimilar to Roche’s Avastin and the first cancer biosimilar to be approved for use in the US. Mvasi will be indicated for adult patients affected by certain colorectal, lung, brain, kidney, and cervical cancers. The potential patient population for Mvasi is therefore considerable and with the high cost of Avastin being a barrier to many patients, uptake is likely to be impressive—if the drug launches on the market.

With Avastin generating a staggering $3.1 billion in sales in 2016 according to GlobalData, the threat of biosimilar entry is not one Roche will take lightly. Roche has been fighting the eventuality of biosimilars with many complaints; however, as the patent expiry date looms closer, the company is likely to face more of the same as other companies look to steal a piece of Avastin’s sizeable pie.

Avastin is currently protected by patents until 2019, but patients should not hope for the launch of Mvasi upon its expiration.

Of the seven biosimilars deemed bioequivalent by the FDA since the approval of the first biosimilar in 2015, only three are currently available for sale. The rest are tied up lengthy legal disputes, delaying the entry of cheaper treatments into the market. Given the substantial resources behind these branded biosimilars and the multitude of patents protecting them, manufacturers are able to tie biosimilar companies up in patent battles for many years. Amgen should be prepared for Roche to follow this example.

Even if Mvasi is to launch in the market, exclusive deals between Roche and drug plans or payers is likely to hamper competition from its cheaper counterpart. Johnson & Johnson adopted this approach upon the launch of Pfizer’s biosimilar to Remicade became available.

Amgen is yet to comment on the launch date or price of Mvasi.

The horizon does not look good for Roche as it faces the edge of yet another patent cliff, with the FDA set to review Mylan and Biocon’s Herceptin biosimilar in December this year. According to GlobalData, Herceptin generated $2.6 billion in 2016 sales for this pharmaceutical giant in the US.