Shots: This is the first launch of a biosimilar to Humira in Japan. Mylan EPD will lead the commercialization of the biosimilar The launch is a testament to the power […]readmore
Tags : Adalimumab Biosimilar
Shots: The approval is granted in pediatric plaque psoriasis and non-infectious intermediate uveitis, posterior uveitis and panuveitis in adults, who do not respond adequately to corticosteroids. These are fifth and […]readmore
Shot: The companies expand their strategic partnership to commercialize six new biosimilar product candidates for the Asian markets In Mar’2020, the companies collaborated for AVT02 (biosimilar, adalimumab). The collaboration targets […]readmore
Biosimilars
Biotech
Regulatory
Samsung Bioepis’ BLA for SB5 Adalimumab Biosimilar Accepted for Review
Shots: The BLA (Biologics License Application) has been accepted under the 351(k) pathway for SB5, which was filed by Samsung Bioepis in Jul 2018. Samsung Bioepis’ SB5 is already approved […]readmore
Biosimilars
Biotech
Regulatory
Mylan Receives EU Marketing Approval for Adalimumab Biosimilar “Hulio”
Shots: Hulio’s EU Marketing Approval is followed after CHMP approval that demonstrated analytical, functional, clinical and immunogenicity data similar to AbbVie’s Humira In 2018, Kyowa and Mylan signed an agreement […]readmore