FDA Accepts BLA for Alvotech Ustekinumab Biosimilar

The FDA has accepted a biologics license application (BLA) for Alvotech’s ustekinumab biosimilar candidate (AVT04) referencing Stelara, which will be used to treat several autoimmune disorders, according to a statement from the company.

“The progress of AVT04 helps to validate the end-to-end biosimilars development and manufacturing platform that we have built at Alvotech…. Our approach is multi-product, and we look forward to broadening our portfolio as we continue to focus on expanding access to affordable biologic medicines,” said Joseph McClellan, chief scientific officer of Alvotech.

Ustekinumab products are monoclonal antibodies that act as inhibitors for interleukin (IL)-12 and IL-23. Stelara, developed by Janssen Pharmaceuticals, is indicated for the treatment of patients with psoriatic arthritis, plaque psoriasis, and inflammatory bowel disease, which is an umbrella term for ulcerative colitis and Crohn disease.

Alvotech has a commercialization partnership with Teva Pharmaceuticals, which will have exclusive rights to marketing AVT04 in the United States if it is approved. The companies anticipate the FDA’s final decision on AVT04 to come in the second half of 2023.

“We are pleased to be one step closer to making AVT04 available to patients and providers as a biosimilar treatment option to Stelara® for indicated inflammatory conditions…. Teva continues to remain focused on our commitment to lower healthcare costs and expand the availability and access of biosimilars,” commented Christine Baeder, senior vice president and chief operating officer of US Generics at Teva.

Alvotech and Teva’s partnership began in August 2020 and concerns 5 biosimilar candidates, including an adalimumab biosimilar (AVT02) referencing Humira. AVT02 is currently under review with the FDA and is expected to enter the US market in July 2022, along with 6 other adalimumab biosimilars.

In May 2022, Alvotech shared data that confirmed the clinical safety and efficacy of AVT04 compared to the reference product in patients with moderate to severe chronic plaque psoriasis as well as positive results from a phase 1 pharmacokinetic equivalence study.

Other Ustekinumab Biosimilars

The news comes after Janssen, a division of Johnson & Johnson and the owner of Stelara, sued Amgen over its ustekinumab biosimilar candidate. Janssen claimed that Amgen infringed on 2 of its patents when creating the biosimilar.

In addition to Alvotech and Amgen, California-based Rani Therapeutics is in the preclinical development staged for RT-111, a RaniPill Go capsule to administer an ustekinumab biosimilar. The RaniPill capsule would allow for oral delivery of the drug.

Biocon Biologics entered into a licensing agreement with Yoshindo for the commercialization of its ustekinumab biosimilar in Japan in October 2022. Formycon published positive phase 3 bioequivalence data for its ustekinumab biosimilar, for which the company acquired from ATHOS. Bio-Thera and Hikma Pharmaceuticals have also partnered to compete against Stelara with a biosimilar (BAT2206). Hikma would be in charge of US commercialization.