Tags : Hulio

Insights+ Key Biosimilars Events of July 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference […]Read More

Mylan and Fujifilm Kyowa Kirin Receive the US FDA’s Approval

Shots: The US FDA has approved Hulio (adalimumab-fkjp), a biosimilar to AbbVie’s Humira (adalimumab) to treat RA, JIA (in patients aged ≥4yrs.), PsA, AS, adult CD,  UC, and PsO, in both prefilled syringe and auto-injector presentations The approval is on based analytical, pre/ clinical program. The P-III ARABESC study conducted by Fujifilm Kyowa Kirin, demonstrated […]Read More

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 for exclusive commercialization right of Hulio in EU, and is expect to launch on or after 16 Oct, 2018 Adalimumab is an injectable, biologic medication […]Read More