In a significant development for the pharmaceutical industry, Dr. Reddy’s Laboratories Ltd. has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) regarding its proposed biosimilar, DRL_RI, also known as ITUXREDI. This endorsement could pave the way for the launch of this promising biosimilar across European […]
Samsung Bioepis, a South Korean leader in biopharmaceuticals, has struck a deal with private equity firm C-Bridge Capital to develop and commercialize next-generation biosimilars in China. This strategic licensing agreement will see C-Bridge set up a new biopharma venture, AffaMed Therapeutics, to collaborate with Samsung Bioepis on key areas including clinical development, regulatory registration, and […]
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. […]
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 […]