Monday, October 24, 2011

So We're Courting Biosimilars After All -- For Market Access

How times change. Once the evil Queen in branded biotechs' hugely profitable fairy-story, biosimilars has turned into, if not the attractive prince, then at least a character worth courting.

"We believe that biosimilars have a role to play, provided they are safe and effective, so we are investigating new ways to serve patients in this rapidly evolving field," declared Amgen's SVP, R&D, Joe Miletich in an emailed statement last week. He wouldn't say much more, and no-one wanted to be interviewed about this new relationship. But Amgen is far from alone in wooing copy-cat biologics.

Biogen Idec's trying to do it as well, albeit with the help of a partner, since it's got too much to do with the Phase III pipeline in-house. Thus although "a bit effort of our own isn't on the cards," according to CEO George Scangos, "I do think there will be a market. So we're in discussions now, with folk who can take it on with us," he told the audience at Elsevier's recent Pharmaceuticals Strategic Alliances conference.

Meanwhile private Boehringer Ingelheim, too, is trying to join this party -- and do so rather earlier than it did in the case of original therapeutic biologics (where it mostly failed to leverage its significant production and manufacturing expertise, missing out on pharma's biologics land-grab of the decade gone by). "It is our objective to be one of the major players in this field," the company told us, by building its own internal pipeline to commercialize in the US and Europe. "We feel confident that we are able to leverage our capabilities in product development, supply and clinical expertise at Boehringer Ingelheim to offer high quality products understanding the patients’ needs."

So there's the secret: patients' needs. Or let's call it payers' needs. Innovators – not just the traditional large molecule players, but Big Pharma such as Merck and Wyeth-ed Pfizer, too – are falling over themselves for a piece of this multi-billion dollar pie, in part as a nice way to solve the in part since it represents spot-on where payers' -- the customers'-- demands are going right now across the sector as a whole: toward cheaper, safe medicines that are good enough, rather than the absolute best.

And as the new biosimilar players jockey for market share (look out for our November issue of IN VIVO for more on how), they'll be forced – at least as long as automatic substitution remains off the cards -- to emphasize precisely those un-sexy peripherals such as route of administration, formulation and compliance support services that are so valuable to payers and patients, in order to compete.

Biosimilars is a useful friend to get to know, in other words – if you aren't already quietly connected. Alongside the grand declarers are players like Lilly, with its biosimilar version of Sanofi's basal insulin Lantus approaching Phase III, and Inspiration, which just filed a biosimilar Factor IX in Europe for hemophilia B. Everyone's hoping that biosimilars will soon generate rather more of that commercial magic that their fairy-tale promised, but has thus far struggled to deliver.

image by flickrer princessashley used under creative commons

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