Alvotech Broadens Access to HUMIRA (adalimumab) Biosimilars

Alvotech announced yesterday the launch of HUKYNDRA, a high-concentration, low-volume, citrate-free biosimilar to HUMIRA (adalimumab), in Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania, and Slovenia.  Through a strategic partnership with STADA, Alvotech supplies HUKYNDRA (adalimumab) autoinjectors and pre-filled syringes with drug product and drug substance manufactured in its vertically integrated European facility in Reykjavik, Iceland.  According to the press release, STADA is “supporting adalimumab launches in individual national markets through tailored educational materials and dedicated patient-support programs.”  This latest launch follows the prior introduction of HUKYNDRA in nine other European countries.

Anil Okay, Chief Commercial Officer of Alvotech, remarked: “We are very pleased with the reception of HUKYNDRA in the European market, and believe the patient-friendly autoinjector design we have introduced supports commercial success. The partnership with STADA continues to broaden access to cost-effective biologics across Europe in line with our shared vision.”

Last month Alvotech announced that the Therapeutic Goods Administration of Australia has granted marketing authorization to Cipla Australia Pty Ltd. (“Cipla”) for Alvotech’s high-concentration low-volume biosimilar to HUMIRA (adalimumab).  The announcement states that in Australia, the biosimilar will be marketed as CIPTUNEC/ARDALICIP and that “[t]his is the first approved biosimilar from an exclusive commercialization partnership between Alvotech and Cipla.”