Tags : Insulin Glargine

Lannett to Submit Biosimilar Application to the US FDA for

Tuba Khan June 12, 2020

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

Biotech

Sanofi Reports Results of Toujeo (insulin glargine 300 Units/mL) in

Tuba Khan November 4, 2019

Shots: The P-III EDITION JUNIOR study involves assessing Toujeo vs Gla-100 (insulin glargine 100 Units/mL) in 463 children and adolescents aged 6-17yrs. with T1D for at least 1yr. and with HbA1c b/w 7.5% and 11.0% at screening The P-III EDITION JUNIOR study resulted in meeting its 1EPs i.e, reduction in average blood sugar over 6 […]Read More

Biosimilars

Biocon and Mylan Launch Semglee (biosimilar, Insulin Glargine) in Australia

Vartika Singh October 3, 2019

Shots: Biocon & Mylan launch the Semglee (insulin glargine solution for injection 100 IU/mL in a 3mL pre-filled pen) as the first Insulin Glargine biosimilar in Australia available on the PBS The TGA approval is based on the data demonstrated high bio-similarity of Semglee with the reference, Insulin Glargine. The launch of Semglee will increase […]Read More

Biosimilars Regulatory

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

Tuba Khan August 22, 2019

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

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Tags : Insulin Glargine

Lannett to Submit Biosimilar Application to the US FDA for

Sanofi Reports Results of Toujeo (insulin glargine 300 Units/mL) in

Biocon and Mylan Launch Semglee (biosimilar, Insulin Glargine) in Australia

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

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Tags : Insulin Glargine

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