It’s FiercePharma’s final issue of 2016, and as is our tradition, we’ve devoted it to the trends and issues we expect to drive the industry—and related debate—in the coming year. The broad themes aren’t tough to identify. But predicting the specifics, some of them quite important, is, this year, less like reading a crystal ball and more like picking up a Magic 8 Ball. Without a doubt, it says one minute. My reply is no, the next.
As always, drugmakers will rely on M&A of one sort or another to fuel growth and augment pipelines. As has been pharma’s practice recently, sales and spinoffs will also play a role, with Biogen’s hemophilia business Bioverativ being one example. But just how much cash buyers have to play with depends on an as-yet-unmade decision: Whether U.S. companies can bring home their offshore cash tax-free. Outlook good, which means billions more dollars for U.S. deals and, probably, higher prices as that cash chases a limited number of solid acquisition targets.
Or take biosimilars, the threat to biologic drug prices and monopolies that’s been on its way for years. The U.S. had its first launch in 2016 in Novartis’ Zarxio, rolled out by its Sandoz unit to compete with Amgen’s originator drug Neupogen. But that drug couldn’t tell us much in isolation. Now that Pfizer has launched its Remicade biosim Inflectra, and Eli Lilly and Boehringer Ingelheim their Lantus rival Basaglar, we’ll have more data to apply to future launches. How quickly will doctors and patients ride the new wave of products? Remicade maker Johnson & Johnson maintains that brand loyalty and smart pricing will keep its blockbuster on solid ground. But Merck, which sells Remicade in Europe, might have hoped the same once biosims won E.U. approval, and it didn’t quite turn out that way. Will the European experience follow in the U.S.? Reply hazy, try again.
Manufacturing brought a round of surprises in 2016 as the FDA rejected a series of new drugs because of questions about—or criticisms of—the plants where they’d be produced. Sanofi and Regeneron’s sarilumab, for instance, was held up by issues at a fill-finish plant in France. Roche’s new multiple sclerosis drug Ocrevus (ocrelizumab) was delayed after the Swiss drugmaker handed U.S. regulators more data about its manufacturing of that med. Will the FDA continue its close focus on manufacturing of new meds? That likely depends—at least after January 20—on whom President-elect Trump appoints to lead the agency. If libertarian Jim O’Neill, well, My sources say no.
In marketing, pharma’s shift to specialty drugs from mass-market blockbusters hasn’t put a dent in DTC budgets, despite the fact that their target populations are far smaller. Drugmakers have stubbornly clung to old-school marketing that focuses on mass media, and while that might be good for TV networks and AARP magazine, it may not be so good for pharma marketing. Drugmakers, for instance, might actually save some money on promotions if they adopted digital and social media on a broader basis. Will pharma stay stuck in TV mode in 2017? Signs point to yes.
Signs point to definitely when it comes to the drug pricing debate continuing into 2017, but it’s far from definite where that debate will go next. Even more indefinite is what sort of action the talk might yield. The real world offers a lot of possibilities, but with a presidential administration that’s an unknown quantity, other “outlier” price-hike examples ready and waiting for protestors to pounce on—and the industry’s own initiatives brewing, plenty of it behind the scenes—even the Magic 8 Ball would have trouble handicapping them all. Medicare price negotiation? Speedier generic approvals? An industrywide self-policing document? Better not tell you now, it says. Then, Concentrate and ask again.
Ask whether we’ll be covering all these trends and more, and the answer is unequivocal: It is certain, says the Magic 8 Ball, and all of us here at FiercePharma. You, our readers, can help us with that, too. Have story ideas or tips to share? Please get in touch. And in the meantime, have a safe and happy holiday season. See you next year.