Organon, Samsung Bioepis launch HUMIRA biosimilar HADLIMA in US

Organon, Samsung Bioepis launch HUMIRA biosimilar HADLIMA in US

Organon & Co. and Samsung Bioepis revealed that HADLIMA (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab), is now accessible to patients in the United States. This development ensures a seamless continuity of care as HADLIMA is available in both citrate-free high concentration (100 mg/mL) and citrate-containing low concentration (50 mg/mL), similar to Humira. HADLIMA, a tumor […]

Pfizer, AbbVie settle global IP for Humira biosimilar, paving way for European launch

Pfizer, AbbVie settle global IP for Humira biosimilar, paving way for European launch

In a significant step towards expanding biosimilar access, Pfizer and AbbVie have resolved all global intellectual property disputes concerning Pfizer’s proposed biosimilar to AbbVie’s blockbuster rheumatoid arthritis drug, Humira (adalimumab). This agreement marks a major milestone in Pfizer’s mission to broaden its portfolio of biosimilar medications, as it acquires a non-exclusive patent license to market […]

Mylan launches Hulio, a biosimilar to Humira, across major European markets

Mylan launches Hulio, a biosimilar to Humira, across major European markets

Mylan has officially launched Hulio, its biosimilar to AbbVie’s Humira (adalimumab), across major European markets. This launch follows the European Commission’s recent approval of Hulio for all indications of the reference product. Hulio will be accessible to patients in Europe as soon as possible, thanks to a partnership between Mylan and Fujifilm Kyowa Kirin Biologics. […]

Boehringer Ingelheim’s Cyltezo achieves clinical equivalence to Humira in Phase 3 psoriasis trial

Boehringer Ingelheim’s Cyltezo achieves clinical equivalence to Humira in Phase 3 psoriasis trial

German pharmaceutical giant Boehringer Ingelheim has announced a significant milestone in the treatment of moderate-to-severe chronic plaque psoriasis. Their drug, Cyltezo, a biosimilar to AbbVie’s renowned psoriasis medication Humira (Adalimumab), has demonstrated clinical equivalence in a pivotal phase 3 trial, known as NCT 02850965. The trial successfully met its primary endpoint, which was the proportion […]

Novartis’ Sandoz gains EC approval for biosimilar Hyrimoz across multiple therapeutic areas

Novartis’ Sandoz gains EC approval for biosimilar Hyrimoz across multiple therapeutic areas

In a significant advancement for biopharmaceuticals, Novartis’ division Sandoz has secured approval from the European Commission (EC) for Hyrimoz (adalimumab), a biosimilar to AbbVie’s Humira. This approval encompasses all indications of the reference drug, including treatment for rheumatoid arthritis, Crohn’s disease, plaque psoriasis, uveitis, and ulcerative colitis, marking a pivotal step in broadening access to […]