Fresh from writing off one of its top late-stage programs, Merck KGaA stepped up with a revised comeback plan today, detailing plans to invest about $500 million in a late-stage effort to develop new biosimilars while scouting for a major-league partner to come in on its PD-L1 immuno-oncology program. And the company pointed to its current lineup of three star players in the pipeline, including one that has already posted a clinical failure.
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.
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.
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.
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 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.
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.
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.
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.
Eli Lilly and Boehringer Ingelheim say their in-development Lantus biosimilar proved as safe and effective as its reference treatment across 6 clinical trials.