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.
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.
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.
Merck KGaA has long said it's not affraid to spend big on bolstering its pipeline, and part of the German drugmaker's value-creation plan is a sizable investment in biosimilars.