Topic:

Biosimilars

Latest Headlines

Latest Headlines

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.

FDA opens the door for a Novartis biosimilar of Amgen's Neupogen

The FDA accepted Novartis' application to sell a knockoff of Amgen's biological treatment Neupogen, making the company a pioneer among those looking to capitalize on a soon-to-come U.S. market for biosimilars that is expected to explode.

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.

Sanofi ups the legal ante to block Lilly's Lantus biosimilar

Sanofi has filed another lawsuit against Eli Lilly in hopes of beating back a biosimilar challenge for its top-selling insulin product, claiming its rival's in-development knockoff infringes its intellectual property.

BioOutsource plots a U.S. expansion with eyes on biosimilars

Scottish contractor BioOutsource is planning a deeper dive into the U.S. market for development services, setting sights on a new lab in Massachusetts to serve its American clientele.

Lilly and Boehringer inch closer to challenging Lantus with EU nod

Eli Lilly and Boehringer Ingelheim have convinced European regulators to recommend their biosimilar of Sanofi's Lantus, the world's top-selling insulin, setting the stage for a near-term approval and launch once the reference product comes off patent next year.

InVentiv, Oncobiologics kick off their biosimilar alliance, target Humira

CRO inVentiv Health and biotech partner Oncobiologics have a plot to cash in on the burgeoning market for knockoffs of biotech drugs, and the two have begun development on a biosimilar of the blockbuster Humira.

Boehringer, Lilly creep up on Sanofi with Lantus biosimilar

Eli Lilly and Boehringer Ingelheim say their in-development Lantus biosimilar proved as safe and effective as its reference treatment across 6 clinical trials.

Pfenex eyes a $75M IPO to bankroll its biosimilars

San Diego biotech Pfenex has evolved from helping Big Pharma craft large-molecule therapies to developing biosimilars of its own, and now the company is looking to raise about $74.8 million to cash in on the coming boom in biologic knockoffs.

FDA breaks silence on biosimilars with long-awaited proposal

For years, the FDA has been unveiling its plan for regulating knockoffs of blockbuster biologics in fits and starts, this week outlining just how it wants to define biosimilarity for would-be copycat drugs.