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It looks like the SC Perjeta/Herceptin fixed dose

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maumar Member Level  Friday, 02/01/19 02:53:08 PM
Re: Fred Kadiddlehopper post# 5577
Post # of 5631 
It looks like the SC Perjeta/Herceptin fixed dose combination may get filed later this year and launched in 2020.

From the Roche earnings call transcript:

"Bill Anderson

And so we're talking about the fixed dose of Herceptin plus PERJETA. And I think this is -- I mean, it's an attractive option, particularly for patients who aren't receiving chemo, which, for example, in the adjuvant setting, they're not getting chemo, and so it's a choice between coming in and getting an infusion of Herceptin and an infusion of PERJETA or coming in with a really simple injection with Halozyme. And we think, over time, it's going to make sense because it's just -- it's better. It's more convenient.

And I think it may be the kind of thing that takes a while to convert if physicians are comfortable with the practice of doing the multiple infusions. But there's a lot of patients getting a lot of infusions there. I mean, Herceptin plus PERJETA is the standard of care in metastatic breast cancer, standard of care in early breast cancer. And it starts to get pretty compelling, even more so than the switch from, say, Herceptin IV to Herceptin SubQ because there, you're just replacing one infusion and now you've got an opportunity to replace two.

...

Mark Purcell

It's Mark Purcell from Morgan Stanley. I was just going to follow up on the same subject there. I guess the life cycle management behind the CD20 franchise is very clear, that hurts your franchise slightly less, that a bispecific earlier in development better. Just in terms of the timing, it doesn't look like you're going to launch a subcut Herceptin in the U.S. You're going to go straight to the combination. And given you have visibility on three of the five players, and the first one, the biosimilar's going to be launched with very limited capacity for the first few years, I just wondered, obviously, you guide on risk rather than likely outcome, but if the decision to go with a 2020 launch on the combination is related to what could be a greater window than currently people are modeling.

...

Bill Anderson

Okay. That's quite a list. Actually, the first answer is there's a relatively straightforward answer. We are launching Herceptin SubQ in the U.S. It -- yes, it was a long journey because it wasn't clear the regulator was going to support it, and then we had to get it -- and then we had a priority on resources in EU because it was an ongoing launch. So basically, we were -- yes, we were delayed on time lines, but we are planning to bring it to market. I don't have an update on the timing, but -- and so there have been no decisions about prioritizing the fixed dose combination over SubQ Herceptin. We're going to bring SubQ Herceptin as fast as we can clear the regulatory process, and then we'll bring the fixed dose also as fast as we can bring it."

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