Tag:

biosimilars

Latest Headlines

Latest Headlines

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.

Big investors urge drugmakers to stop badmouthing biosimilars

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.

Docs to FDA: Biosimilars should have different names than branded drugs

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.

New era about to dawn: Novartis, and now Celltrion, present biosimilars to the FDA

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.

Celltrion targets J&J's Remicade as biosimilars loom in the U.S.

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.

Biosimilars set to boom as new patent cliff on biologic superstars looms

If you look at the biosimilars market as a global whole, the sum total of revenue generated by the follow-on crowd just barely crossed into blockbuster territory in 2013, according to a new study from Allied Marketing Research. But that $1.3 billion base is expected to swell to $35 billion by 2020 as new products penetrate the market in North America, Europe and Asia.

Glenmark to build $100M plant in North America

Glenmark has more than a dozen manufacturing plants around the world, recently opening a mAb manufacturing facility in Switzerland to feed its pipeline of monoclonal antibodies and biosimilars. But the Indian generics maker does not have a plant in North America and figures it is time.

Serum Institute allies with biotech in bid to cut cost of biosimilar production

The biosimilars market has attracted some big companies with even bigger claims about their ability to drive down manufacturing costs, with Samsung and its ambition to undercut biologic prices by 50% the standout example. Now a small Australian biotech is trumpeting the cost-saving it can realize after marrying its expression technology to the scale of the Serum Institute of India.