The patent provisions of the Hatch-Waxman Act are familiar to both sides of the branded-generic fence by now. Not so when it comes to similar procedures related to biosimilars. In fact, as a lawsuit over Sandoz's knockoff version of the Amgen therapy Neupogen shows, the two sides don't even agree on the rules.
The market for Humira is a large one: the med raked in $11.02 billion last year to top the list of the world's best-selling drugs. So it's no surprise that biosimilar developers are going after a piece of that market--including Amgen, which released some head-to-head data last week that could help it make its regulatory case.
Amgen has taken a big stride toward gaining regulatory approval for its biosimilar of Humira, AbbVie's megablockbuster anti-inflammatory. The Big Biotech reports today that its knockoff of Humira--dubbed ABP 501--hit its marks on equivalency for efficacy and safety for treating plaque psoriasis.
Thomson Reuters BioWorld took a deep dive into the subject and surfaced today with a detailed report outlining a bustling new global business with roughly 700 so-called follow-ons put in the clinic by 245 companies and institutions. Looking ahead to 2020, analysts say, you can anticipate that biosimilars will account for about $25 billion out of $100 billion in sales for off-patent biologics.
Swiss drugmaker Novartis last month became the first drugmaker to present the FDA with an application for a biosimilar, kicking off a new era in the U.S. that many believe will be a game changer for the industry. But from where CEO Joe Jimenez sits, it looks like no big deal for now.
Novartis' big generics operation at Sandoz has been one of the leaders in the field of biosimilar development. So when the chief lays out a timetable on the adoption of these long-awaited knockoffs of some of the industry's biggest biologics, FierceBiotech listens.
As the FDA considers whether it should approve recently filed biosimilar versions of Johnson & Johnson's Remicade and Amgen's Neupogen, a parade of pharma companies, physicians and payers is coming forward to voice their concerns, not the least of which is how these products will be named. Now another group of concerned parties has joined the chorus: investors.
Ever since the FDA drafted a set of rules for biosimilars in 2012, a debate has been raging over whether those drugs should carry the same generic names as the products they emulate. Now, some doctors are weighing in on the issue, urging the FDA to require biosimilars to have different names than branded biotech drugs.
Biosimilars promise huge potential, with estimates for this decade running from $35 billion to $200 billion and growing exponentially from there. And of course the U.S., being the world's largest pharma market, presents the greatest potential, once someone breaks in and acceptance can be judged.
South Korea's Celltrion is aiming to be second in line when biosimilars make their U.S. landfall, filing an FDA application to market a knockoff of Johnson & Johnson's blockbuster Remicade.