Tag Archive for: biosimilar

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 Swiss pharma has set up its challenge to AbbVie’s blockbuster immunosuppressive drug Humira with a label expansion for Cosentyx in hidradenitis suppurativa, a painful long-term skin condition.

The agency approved the drug to treat multiple inflammatory diseases.

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.

Boehringer Ingelheim on Monday unveiled lower wholesale pricing for its adalimumab-adbm injection, the company’s interchangeable biosimilar to AbbVie’s blockbuster chronic inflammatory therapy Humira (adalimumab).

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.

For Sandoz, which is due to become an independent company early next month, the transaction means more investment in the growing market of biosimilars, which are lower-cost copies of complex biotech drugs that have lost patent protection.

The FDA on Thursday approved Sandoz’s Tyruko (natalizumab-sztn), a biosimilar of Biogen’s blockbuster treatment Tysabri (natalizumab), a monotherapy for the treatment of adults with relapsing forms of multiple sclerosis.