The US Federal Trade Commission (FTC) has granted conditional approval for Dutch pharma company Mylan’s acquisition of Upjohn, the off-patent branded and generic established medicines business of Pfizer. The deal was announced in July 2019 with an objective to create a new global pharma company through the merger of Mylan and Upjohn, which will be […]
Dutch generic drugmaker Mylan said that the US District Court for the Northern District of West Virginia has invalidated Biogen’s Tecfidera patent U.S. Patent No. 8,399,514 for lack of written description. According to the company, the 8,399,514 patent claimed methods for the treatment of multiple sclerosis (MS) with a dose of 480 mg/day of dimethyl […]
Mylan and Biocon have secured approval from the US Food and Drug Administration (FDA) for Semglee (insulin glargine injection) in vial and pre-filled pen presentations to regulate high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes. According to Mylan, Semglee has an identical amino acid sequence […]
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 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. […]
Mylan, a global pharmaceutical company, has recently announced the U.S. Food and Drug Administration (FDA) approval of its Estradiol Vaginal Cream USP, 0.01%, a generic version of Allergan’s Estrace. This approval marks a significant addition to Mylan’s comprehensive women’s healthcare offerings, particularly targeting the treatment of vulvar and vaginal atrophy, a condition prevalent among postmenopausal […]
Global pharmaceutical giant Mylan has made a significant stride in the hypertension treatment market with the US launch of the first generic versions of Daiichi Sankyo’s Olmesartan Medoxomil tablets, known commercially as Benicar and Benicar HCT. Introduction of Generic Hypertension Treatments Benicar, available in doses of 5 mg, 20 mg, and 40 mg, and its […]