Mylan and Biocon launch Herceptin biosimilar in US

Mylan and Biocon have launched their Herceptin biosimilar Ogivri in the US, the second challenger to Roche’s breast and stomach cancer blockbuster.

The companies said that they launched Ogivri at a “competitive advantage” compared with Herceptin (trastuzumab) but gave no further details about the price for the drug available in 420 mg and 150 mg vials.

Roche’s Herceptin first encountered competition from biosimilars after Amgen launched its first near-copy in July, along with a biosimilar of the Swiss pharma’s other big cancer drug Avastin.

The price charged for these earlier drugs gives an indication of the discount that Mylan and Biocon are likely to apply.

Unlike generics, biosimilars are approved with a more in-depth and costly dossier of clinical and analytical data as they are complex biologic drugs that are grown in cells.

This means that biosimilars are usually available at a substantial discount compared with the originator but not at the rock-bottom prices associated with generics.

For example, Amgen’s Avastin biosimilar was launched at a wholesale discount price of around 15%.

Roche’s third big-selling cancer drug Rituxan is also in trouble with biosimilar competition after years of dominance and patent expiry last year.

The good news for Roche is that sales erosion in the US has been nowhere near as extreme as that in Europe, where biosimilars have caused sales to tumble rapidly.

Quarterly sales figures show that in Q3, which corresponded with the launch of the first Herceptin biosimilar, sales were down around 6%.

Sales of Avastin were up 1% in Q3 despite the biosimilar competition – but the consensus is that in the long term Roche will be looking for a strong performance from newly launched drugs to make up for lost sales from its 'big three' cancer drugs.

From the Swiss pharma’s point of view things are going well in this regard – the launch of its multiple sclerosis drug Ocrevus (ocrelizumab) is regarded as one of the most successful ever in the pharma industry.

After a first approval in 2017 Ocrevus is already a blockbuster, and its haemophilia drug Hemlibra (emicizumab) is gaining traction quickly after approval in 2018.