Tags : Insulin Glargine

Biosimilars

Lannett to Submit Biosimilar Application to the US FDA for

Shots: Lannett has provided an update on the clinical advancement of its biosimilar Insulin glargine. Following FDA meeting, Lannett has received FDA’s positive feedback on the clinical and CMC advancement of its biosimilar insulin glargine The company anticipates the filing of 351(k) biosimilar application for its biosimilar insulin glargine candidate by the end of 2022 […]Read More

Biosimilars Regulatory

 Biocon Receives EU’s GMP Certification for its Semglee (biosimilar,

Shots: Biocon has received EMA’s certificate of GMP compliance from European inspection authority, Health Products Regulatory Authority (Ireland) and expand its capacities multi-fold with the new large-scale devices facility to meet the need of patients with diabetes in EU The manufacturing facility at Malaysia was inspected in May’2019 and is Asia’s largest integrated insulins facility […]Read More