Biocon Biologics and Civica collaborate to expand Insulin Aspart access in US

There are 38.4 million people with diabetes in the United States

Wockhardt files fast-acting Insulin Aspart injection with DCGI

The market size of Aspart in India is currently estimated over Rs. 260 crore with only 2 players

Biocon Biologics gets complete response letter from USFDA for Biosimilar Insulin Aspart

The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022

USFDA Issues a CRL for the Biologics License Application for Insulin Aspart

The CRL did not identify any outstanding scientific issues with the product.

Biocon Biologics and Viatris receive European Commission approval for Kixelle, Biosimilar Insulin Aspart

The centralized marketing authorization granted by the EC is valid in all EU Member

Biocon Q1 FY26 PAT slips 95% to Rs. 31.4 Cr

Revenue from operations rose 14.8 per cent year-on-year to Rs. 3,942 crore

Biocon Biologics expands diabetes portfolio with FDA approval of Kirsty

Biocon Biologics completes Integration of Viatris' Biosimilar business

The full transition of Viatris' biosimilars operations to Biocon Biologics in Europe represents another significant milestone

Biocon Biologics insulins facility in Malaysia receives EU GMP Certification

The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.

US FDA issues 17 observations for Biocon Biologics sites

The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools