Biosimilars: Empty Threats?

The Jan. 10 announcement by Novartis' Sandoz division of the start of Phase II trials of a biosimilar version of Roche's rituximab (Rituxan) is beginning to look a bit like posturing. After all, when was the last time a biosimilars firm gave away anything about its pipeline, let alone details of a specific compound?

Granted, we knew Sandoz has biosimilar antibodies in the works; they'd told us as much. And it's no real surprise that it's rituximab: big seller ($5.6 billion in 2009), not that many years of patent life remaining (not, at least, if you remember that this is only the start of Phase II...). But why make a song and dance about it if you then don't give away any details?

To scare Roche, of course. CFO Erich Hunziker was reported as having dismissively told investors at JP Morgan last week that "people who want to eat into this [biosimilars] market make announcements every day....", and to have hinted at a super-duper defense strategy which it would be "stupid" to reveal. Maybe it wasn't so super after all: he appears, over the weekend, to have fled (ok, so that's more to do with being spurned for the top-job than with Sandoz's activities.)

But seriously, given that Europe has recently issued guidelines on biosimilar antibodies, we tried to find out more about how Sandoz might be interpreting these. (Ok, so we're a bit naive sometimes.) Like, are you assuming you may be able to get away without clinical efficacy trials? What end-points might you use if there are trials?

Sandoz does, in general terms, "understand the guidelines as requiring clinical development if biosimilarity cannot be demonstrated with valid PK and PD studies," the company said in an email, but "we don't comment in greater detail at this stage on our rituximab development program." Same goes for endpoints, which will be "negotiated on a case by case basis with regulatory agencies," and for whether or not the company will do more trials than strictly necessary in order to provide a convincing body of data for doctors (though Sandoz does concede that "a quality data package" will be required "to convince stakeholders of quality, safety and efficacy").

Ok, so on to the advertised 'robust, high-yield in-house production process' at Sandoz. Could this be used for other antibodies in the pipeline (a pipe that numbers 8-10 molecules overall)? No comment, just the thing about internal synergies, including across the Novartis group as a whole.

Don't get us wrong, we know/believe that Sandoz is among the best-placed competitors in the biosimilars market. And we respect that the company has learnt from -- and thus will be more successful as a result of -- its commercial experience to date, with products including biosimilar growth hormone Omnitrope.

But it's hard to avoid the suspicion that PR like this is a bit, well, airy. With three products on the market, Sandoz doesn't need to waste paper reinforcing its "commitment to maintain global biosimilar market leadership".

And anyway, we've just done it for them.