Alvotech and JAMP Pharma announce receipt of marketing authorization for PrJamtekiTM (AVT04), the first biosimilar of Stelara® (...

REYKJAVIK, Iceland and BOUCHERVILLE, QC, Nov. 14, 2023 /CNW/ - Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and JAMP Pharma Group ("JAMP Pharma"), a Canadian owned pharmaceutical organization headquartered in the Greater Montreal area, announced today that Health Canada has granted JAMP Pharma marketing authorization for AVT04, a biosimilar to Stelara® (ustekinumab) developed by Alvotech. AVT04 will be marketed under the brand name Jamteki^TM.

The currently approved presentations of Jamteki^TM are a 45mg/0.5mL pre-filled syringe with passive safety device for subcutaneous injection (PFS-SD) and the 90mg/mL PFS-SD. This is the second biosimilar to receive marketing authorization, developed under an exclusive commercialization partnership between Alvotech and JAMP Pharma. Last year, the partners launched Simlandi®, a biosimilar to Humira® (adalimumab).

"The introduction of Jamteki^TM is in line with our current biosimilar product offering and showcases JAMP Pharma's commitment to evolve in this market," said Louis Pilon, President and CEO at JAMP Pharma. "Alvotech is an innovative and strategic partner, enabling Canadian patients to benefit from ustekinumab at a lower cost. Patients will also benefit from the expertise of our Patient Support Program – JAMP Care^TM – for an optimal and seamless transition."

"We are very pleased to receive marketing authorization for our second biosimilar in Canada with JAMP Pharma," said Robert Wessman, Chairman and CEO of Alvotech. "Strong demand for biosimilars in Canada indicates that there is a need for affordable quality biologics in the Canadian market. This is an important step for us and for our joint objective to offer broader access to more affordable healthcare."

In February 2022, JAMP Pharma announced the creation of BioJAMP^TM as part of its goal to establish itself as a leader in the Canadian biosimilars market. BioJAMP^TM and the JAMP Care^TM patient support programs are both designed to simplify the transition process to biosimilar medicines for patients and caregivers.

JAMP Pharma and Alvotech announced their exclusive partnership for the commercialization of biosimilars in Canada in January 2022 then expanded the agreement in October 2022. In addition to Simlandi® (adalimumab), which was launched in Canada in April 2022, and Jamteki^TM (ustekinumab), the partnership also includes four biosimilar candidates in clinical development, as well as two biosimilar candidates in pre-clinical development.

About AVT04 (ustekinumab)

AVT04 is a monoclonal antibody and a biosimilar of Stelara® (ustekinumab). Ustekinumab binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses [1]. AVT04 has been approved in Japan, Canada and the European Medicines Agency (EMA) has recommended market authorization in the 27 member states of the European Union, as well as Norway, Iceland and Liechtenstein, pending a final decision by the European Commission.

[1] Product information (canada.ca)

Use of trademarks

Humira® is a registered trademark of AbbVie Biotechnology Ltd. Stelara® is a registered trademark of Johnson & Johnson

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