Biocon Biologics and Viatris receive US FDA approval for maiden interchangeable biosimilar Semglee
Interchangeable designation allows substitution at the pharmacy counter for Lantus across the US to help increase access to…
Sign in
Sign in
Recover your password.
A password will be e-mailed to you.
Browsing Tag
glargine
Biocon Biologics and Viatris get EC Approval for Kixelle, biosimilar insulin Aspart
Kixelle, a fast-acting insulin analog indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1…
Biocon’s partner Mylan receives favourable ruling from US PTAB on Sanofi’s four device patents for…
Reportedly, the PTAB also found Sanofi’s proposed amended claims for the ‘486 and ‘844 patents unpatentable.
USFDA issues response letter for new drug application for insulin glargine: Biocon
As per the USFDA, a Complete Response Letter (CRL) is sent to an applicant if the agency determines that it will not approve the…