On 20 April 2026, PR Newswire reported that Health Canada has approved JAMP Pharma’s Upgolyv™, biosimilar to Janssen’s Simponi® (golimumab), for the treatment of chronic inflammatory autoimmune diseases. Upgolyv™ is the first golimumab biosimilar to be approved in Canada.
Clinical studies relied on by JAMP Pharma in its application for approval of Upgolyv™, AVT05-GL-P01 (NCT05632211) and AVT05-GL-C01 (NCT05842213), were sponsored by Alvotech, and were conducted with the Alvotech-developed golimumab biosimilar, AVT05. It is therefore apparent that Upgolyv™ is being commercialised by JAMP Pharma in Canada via an association with Alvotech. In March 2026, Alvotech confirmed during its Q4/2025 Earnings call that an application for approval of AVT05 had been filed in Canada, with a decision expected in H1 2026, although no commercialisation partner was mentioned at that time.
Alvotech and JAMP Pharma have previously partnered on the Canadian launch of Jamteki® (biosimilar ustekinumab) and announced their exclusive partnership for the commercialisation of five biosimilars in Canada in January 2020, expanded to seven biosimilars in October 2022.
Alvotech’s Gobivaz® (AVT05) was the first golimumab biosimilar approved worldwide in September 2025 in Japan. The launch of Gobivaz® in Japan (commercialised by Fuji Pharma) is planned for May 2026. Gobivaz® received a positive CHMP opinion from the EMA in September 2025, followed by approval in Europe and the UK in November 2025, where it is commercialised by Advanz Pharma. In the US, where AVT05 will be commercialised by Teva, the FDA issued a Complete Response Letter (CRL) for the biosimilar in November 2025.
Bio-Thera’s Gotenfia®/BAT2506 (golimumab ), marketed by STADA in the EU and UK, received a positive CHMP opinion in December 2025 and EU approval in February 2026. Bio-Thera’s BLA for BAT2506 was accepted for review by the FDA in July 2025. However, there is ongoing US litigation relating to BAT2506, with Janssen having filed proceedings against Bio-Thera Solutions/Accord BioPharma, alleging infringement of 17 patents. A preliminary injunction application by Janssen is due to be heard in August or the beginning of September 2026.