Biotech | September 26, 2021
U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations
The company does not expect the outcome of this inspection to impact its plans
The company does not expect the outcome of this inspection to impact its plans
BB will have access to 100 million doses of vaccines annually and commercialization rights of the SILS vaccine portfolio for global markets
Revlimid is a blood cancer drug with sales of US $ 12.1 billion in 2020
The company is eligible for 12 months exclusivity from launch
ADG20, a novel monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses
Q1 FY22 consolidated revenue grew 6% to Rs. 1,808 crore from Rs. 1,712 crore in Q1 FY21. Q1 FY22 Net Profit was Rs. 84 crore (vs. Rs. 149 crore in Q1 FY21).
The progress has been encouraging with approvals and launches in the US, EU, Japan, Australia and Emerging Markets. Post Mylan Upjohn (Pfizer) merger, the scope has been extended to China as well.
The drug is approved for the treatment in metastatic colorectal carcinoma, metastatic breast cancer and ovarian, cervical and renal cancer
The company has received a certificate of Good Manufacturing Practice compliance from the Medicines & Healthcare products Regulatory Agency (MHRA) UK
Biocon Pharma will be responsible for drug development and manufacturing, while Libbs will leverage its deep expertise and reach in Brazil to import, distribute and market
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