Roche's O'Day doesn't see Herceptin biosimilar threat until late 2017

By EJ Lane Jul 24, 2016 7:44pm

Roche’s ($RHBBY) top pharmaceutical executive gave the state of play for what the Swiss-based company said is a likely timeline for a Herceptin biosimilar. He sees about a year of exclusivity remaining.

Dan O'Day, CEO for Roche Pharmaceuticals, did say that demand for Herceptin (trastuzumab)‎ and other existing biosimilars is driving manufacturing expansion and the company also needs to prepare for new products.

"We are looking, of course, at both increasing significantly our manufacturing capacity for all the monoclonal antibodies that are both growing today that we have on the market, but also the new ones to come," O'Day said.

"And that investment is going as planned, and our capacity is increasing as planned, which will be needed for even the early launches."

But at the same time with Herceptin biosimilar threats from South Korea's Celltrion and a partnership from Biocon-Mylan ($MYL), that the companies say may be on the market as soon as next year, O'Day took a longer view.

"We don't really have a Herceptin filing so far," O'Day said on the call. "Celltrion did a bit of a rolling file but, given the data we've seen, we don't expect that in 2017."

"Having said that, we do expect others to be filing with Herceptin between now and the end of the year. We'll see, but we expect that. And, therefore, we expect both Herceptin and MabThera (rituximab) biosimilar entrants between mid-next year to, I would say, the end of the next year at this stage. At least one entrant. And we'll see if there will be multiple, but that will depend, of course, on the filings as well."

"So, I would agree that at this stage the main exposure for our business would certainly be more in 2018 than 2017. But we remain, of course, diligent about how to prepare for that entry."

- here's the earnings release

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