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Alvotech enters supply agreement with Advanz for five biosimilars including golimumab and vedolizumab in EU, UK and CH following Stada termination

May 22, 2023

Alvotech announced that it has entered into a master license and supply agreement with Advanz to commercialise and supply in Europe AVT05 (biosimilar to Janssen’s Simponi® and Simponi Aria® (golimumab)), AVT16 (biosimilar to Takeda’s Entyvio® (vedolizumab)), and three additional early-stage, undisclosed biosimilar candidates.

Under this agreement:

  • Alvotech will develop the products and provide the dossiers.
  • Advanz has an exclusive right to obtain and maintain regulatory approvals for the products and to commercialize them in the European Economic Area, the United Kingdom and Switzerland
  • Advanz will make upfront payments of €56M
  • Advanz will make additional milestone payments for an aggregate amount of up to €264
  • Alvotech will manufacture, supply and deliver the product to Advanz
  • Advanz will exclusively buy the relevant biosimilar candidate from Alvotech at a royalty of approximately 40% of the estimated net selling price or an agreed-upon floor price

On 19 May 2023, Alvotech and STADA entered into three termination agreements to terminate the license and supply agreements between Alvotech and STADA pertaining to Alvotech’s product candidates AVT03 (biosimilar candidate to Prolia®/Xgeva® (denosumab)), AVT05 and AVT16.  Alvotech will repay €17.4M it received from STADA under the (now terminated) agreement.

On 19 May 2023, Alvotech also disclosed the reference products for two product candidates in its pipeline: AVT16 (above) and the reference product for AVT33 is Merck’s Keytruda® (pembrolizumab).

This comes after Alvotech announced in February 2023 that it entered an exclusive agreement with Advanz Pharma regarding   for EU, UK CA, CH and ANZ.