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biosimilars

Latest Headlines

Latest Headlines

To substitute or not to substitute? Biotechs and biosim makers compromise on legislation

Biotech companies and biosimilars makers have been squabbling for years about the way the lower-cost copies will be prescribed and distributed. Brand makers wanted to raise hurdles to replacing their meds with biosimilar versions. But now, with biosimilars nearing their U.S. debut, the two sides have reached a compromise.

Pfizer believes a dose of confidence will help it sell biosimilars

As drug prices climb and expensive newcomers inspire payers to get creative to contain costs, a window is widening for meds that can drive efficiency for healthcare systems and address consumers' needs. That's where biosimilars come in--or so Pfizer figures.

Pfizer believes a dose of confidence will help it sell biosimilars

Biosimilars are in high demand, and Pfizer is looking to cash in on the trend with copycat meds that drive efficiency for healthcare systems and address consumers' needs, Diem Nguyen, general manager of Pfizer's Biosimilars, told FiercePharmaMarketing.

Epirus and Ranbaxy launch a Remicade biosimilar in India

The biosimilar bonanza is underway, and Johnson & Johnson's rheumatoid arthritis drug Remicade is at the center of the copycat action. Boston-based biosimilar maker Epirus Biopharmaceuticals is rolling out a knockoff of the monoclonal antibody (mAb) in India with partner Ranbaxy Laboratories, a year after Hospira got its Remicade version approved in Europe.

Amgen-Sandoz squabble over Neupogen copy could reshape biosim marketing

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.  

Can Amgen's marketing muscle vault its Humira biosim ahead of rivals?

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 declares a head-to-head PhIII win for Humira biosimilar

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. 

Just how big is the biosimilars business going to be in 5 years?

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.

Novartis CEO Jimenez shrugs off biosimilars in the short term

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 CEO predicts a looming biosimilars boom

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.