News | March 07, 2025
Biocon Biologics and Civica collaborate to expand Insulin Aspart access in US
There are 38.4 million people with diabetes in the United States
There are 38.4 million people with diabetes in the United States
The market size of Aspart in India is currently estimated over Rs. 260 crore with only 2 players
The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022
The CRL did not identify any outstanding scientific issues with the product.
The centralized marketing authorization granted by the EC is valid in all EU Member
The full transition of Viatris' biosimilars operations to Biocon Biologics in Europe represents another significant milestone
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
ICICI Direct expects revenue CAGR of 35.6% over FY22-FY24E mainly due to the consolidation of Viatris business and they expect EBITDA margin expansion of 230bps and earnings CAGR of 64.8% over FY22-FY24E
The company does not expect the outcome of this inspection to impact its plans
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