Under the agreement, Dr. Reddy’s gets exclusive commercialization rights in the United States as well as semi-exclusive rights in Europe and United Kingdom, and Alvotech will be responsible for development and manufacture of the product.
Tag Archive for: Alvotech
Like its branded reference product, Selarsdi is a subcutaneous injection that can be used to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis in pediatric and adult patients. Unlike Stelara, however, Selarsdi is not approved for Crohn’s disease and ulcerative colitis.
The FDA on Friday approved Alvotech and Teva’s Simlandi (adalimumab-ryvk), a biosimilar to AbbVie’s blockbuster antibody therapy Humira (adalimumab), ending a long and difficult regulatory road for the partners.
As the last full month of winter 2024 nears an end, the FDA has two target action dates: one for a Humira biosimilar and another for a schizophrenia treatment.
Alvotech said on Thursday it has reached settlement agreements with Johnson & Johnson for launching a biosimilar of the pharmaceutical giant’s blockbuster psoriasis drug Stelara in Japan, Canada, and Europe this year.
The regulator issued a Complete Response Letter citing “deficiencies” at the company’s Reykjavik plant, this time for its Stelara biosimilar AVT04. It’s the fourth FDA rejection for Alvotech since last year.
Bouncing back from two Complete Response Letters, Alvotech’s BLA for its Humira biosimilar AVT02 has been accepted by the regulator with a target action date of Feb. 24, 2024.
Following two BLA rejections for its Humira biosimilar, Alvotech is expanding its partnership with Teva Pharmaceuticals, which will enable the latter to have greater involvement with quality and control.
Following a May 2023 settlement with Amgen, J&J has also signed an agreement with Teva and Alvotech, allowing their Stelara biosimilar to enter the U.S. no later than February 21, 2025.