Monday, September 12, 2011

No Biosimilars on The Horizon, Says Sanofi's Viehbacher

He was talking about biosimilar Lantus, of course, which is the company's most important drug.

During a Q&A session following Sanofi's Sept. 6 'strategy and outlook' seminar for investors, Chris Viehbacher said he didn't expect biosimilars to have "a significant impact on our performance" before 2015.

On one level, he may be justified in brushing off biosimilar insulin, given this is a high-volume, (relatively) low -price play that's unattractive to most competitors -- particular those lacking significant production capacity.

What's more, the insulin market is increasingly about pens and peripherals -- precisely what Sanofi is pushing as it shifts "from Lantus brand-management to Lantus-based solutions," as SVP Diabetes Pierre Chancel put it (and described in this 2010 IN VIVO feature). Hence Sanofi's focus on the SoloSTAR pen (which accounts for 40% of new Lantus scrips in the US), the BGStar glucose monitoring devices, and a forthcoming integrated device for Lantus dosing with a patient-driven titration algorithm.

Such strategies show how biopharma companies are evolving to think beyond the drug -- a topic that will be discussed on September 22 on stage at the Millennium Broadway hotel, the first day of Elsevier's 21st annual Pharmaceutical Strategic Alliances meeting. (And Sanofi will be well represented, with Dennis Urbaniak, Chancel's US deputy in diabetes, weighing in.)

Still, it would be wrong to dismiss biosimilar insulin entirely, however. Lilly has two basal insulins (including a copy of Lantus) starting Phase III this year -- and that's a company, like partner Boehringer Ingelheim, with nothing to lose, but a lot to gain, by entering the basal insulin game.

And certainly biosimilars more broadly remain as hot as they were pre-summer; indeed, the season's continuing economic woes make the prospect of cheaper biologics even more relevant. FDA expects to have its biosimilars guidance in place by the end of 2011, thus paving the way for the second-generation wave of biosimilars, including copies of Enbrel and Rituxan. (Better late than never, we say, although who knows where the user-fee debacle will end up)

Will these more complex biosimilars succeed commercially where many of their first-generation brethren thus far haven't? And will they be just cheap copies, or are innovator-cum-biosimilar players like Merck justified in calling them an entirely new 'proposition', representing 'value and quality', and supported by a well-known brand? And just how abbreviated is FDA's new biosimilars pathway anyway?

In case Urbaniak and other Sanofi execs responsible for Lantus are interested in the answers to such questions, they should stick around for the second day of PSA, which kicks off with a panel that's a veritable who's who of biosimilar experts. Not only will the discussion feature the biosimilars chiefs at Merck and Pfizer (Michael Kamarck and Diem Nguyen respectively), but add in Sandoz's Mark McCamish, FDA's Janice Soreth and Momenta's CMO James Roach and there will be insights into every facet of the biosimilar biz.

Indeed, the companies these panelists represent make up a big chunk of the competition that will determine whether the $50 billion biosimilars opportunity becomes a reality -- and whether Viehbacher's right not to be concerned.

See you there!

Image courtesy of flickrer Old Shoe Woman used with permission under a creative commons license.

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