Biosimilars

Boehringer flags PhIII success for another Humira knockoff, setting up a crowded field of cheaper rivals — eventually

You can count one more likely Humira biosimilar in the growing crowd of rivals looking to tackle AbbVie’s $14 billion franchise.

Germany’s Boehringer Ingelheim has lined up positive Phase III data for its copy of the AbbVie blockbuster. BI 695501 looked equivalent in the late-stage rheumatoid arthritis study, investigators say, and that will likely be all it takes to gain an OK for all the indications Humira is approved for.

The data come just a month after Amgen scored an FDA approval for its Humira copycat. The prospect of several cheaper alternatives piling in at the same time would likely trigger some aggressive discounting as the chief contenders look to carve up the market. But AbbVie is promising to spare no lawyer in its legal offensive to bar any new competition for years to come.

AbbVie has plenty to gain or much to lose when it comes to Humira and the biosimilar market. The company earned about $14 billion off the one franchise last year, and the numbers keep headed north. In the second quarter, its flagship drug brought in $4.15 billion. Humira provides roughly two-thirds of its revenue and AbbVie has been fighting for more time — lots more time — to develop new drugs to take its place.

Amgen, meanwhile, will be pushing to get their copycat — named Amjevita — on the market sometime next year, hoping that once the main patent lapses in December they can fight their way out front. And Boehringer can now join that movement. Meanwhile, Merck/Samsung Bioepis, Novartis and Shire (Baxalta)/Momenta also have knockoffs in the clinic, looking to line up for a share of the market as well.


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RAPS Regulatory Convergence 2017