With J&J settlement, Samsung Bioepis and Sandoz lock down Stelara biosimilar license

30 Nov 2023
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License out/inPatent InfringementDrug Approval
As it stands, Amgen's Stelara biosimilar looks likely to be the first on the scene in early 2025.
As Johnson & JAmgenn’s top moneymaker Stelara nears its patent cliff, biosimilar makers are eager to launch their own versions of the blockbuster immunology med. Now, through a patent settlement, Samsung Bioepis becomes the latest company to score a license to market a Stelara biosim.
PenJohnson & Johnsonval of Samsung Bioepis' biosimilar, the license will allow the company to launch on Feb. 22, 2025, Samsung Bioepis said in a statement.Samsung Bioepis
With the seFDAement, SandozSamsung Bioepisin on the deal too.Samsung Bioepis
The company, which reSandoz completed its split from Novartis, recently struck a deal to commercialize Samsung Bioepis' Stelara biosimilar in the U.S., Canada, Switzerland, the U.K. and countries in Europe.
As for J&J, the drugmaker has inked settlements with Novartisof its potential biosimilar competitors toSamsung Bioepispycats’ market entry dates. So far, only Amgen’s offering has scored FDA approval.
Amgen’sJ&Josimilar, branded as Wezlana, will likely be the first on the scene with a potential launch date of Jan. 1, 2025. Plus, with an FDA interchangeable dAmgenation in hand, the AmgeFDAiosimilar currently boasts an added advantage over other options.
Amgenhile, Teva and Alvotech’s Wezlanad biosimilar was rejected by the FDA last month after a reinspection of Alvotech’s Icelandic manufacFDAing plant revealed shortcomings. Under theAmgenners’ settlement with J&J, their Stelara version can launch no later than Feb. 21, 2025, which in theory gives the two some time to sort through the issues.
Later entriTevaould AlvotechFresenius Kabi and Formycon’s biosimilar, wFDAh has a license date of no later thaAlvotech15, 2025, thanks to another J&J patent settlement.J&J
Stelara is a highly attractiFresenius KabibiosiFormyconkers. The IL-12/23 inhibitor brought in $9.7 billion for J&J last year.J&J
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