CDSCO Issues Draft Guidelines for Biosimilars for Marketing Authorization, Inviting comment From Stakeholders Dr. Divya Colin7 May 2025 6:00 PM ISTNew Delhi: Through a recent notice, the Central Drugs Standard Control Organisation (CDSCO), the Directorate General of Health Services, Government of...
CDSCO Panel Approves Dr Reddy's Laboratories Protocol Amendment Proposal to study Abatacept Dr. Divya Colin3 May 2025 5:45 PM ISTNew Delhi: The Subject Expert Committee (SEC), functional under the Central Drug Standard Control Organisation (CDSCO), has approved Dr Reddys...
Biosimilar Denosumab of Alkem (Denuril) shows Comparable Efficacy in Treating Postmenopausal Osteoporosis in Indian Women Deeksha Bhandari12 April 2025 12:19 PM ISTBiosimilar denosumab of Alkem (Denuril) showed comparable efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity to the innovator...
BRESER Study Demonstrates Real-World Efficacy and Safety of Lupin's Ranibizumab Biosimilar (Ranieyes) Deeksha Bhandari11 April 2025 11:24 AM ISTRanieyes is the Ranibizumab Biosimilar which is an Indian Ranibizumab Biosimilar manufactured by Lupin Ltd & approved in India for various...
Sanofi's Merilog Receives USFDA Approval as Biosimilar to Novolog for Diabetes Management Farhat Nasim17 Feb 2025 7:56 PM ISTNew Delhi: Sanofi has received U.S. Food and Drug Administration (FDA) approval for Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin...
USV Launches INSUQUICK, First Biosimilar Insulin Aspart in India MD Brand Connect1 Nov 2023 5:39 PM ISTUSV Pvt. Ltd, leaders in oral anti-diabetes segment, has announced the launch of 1st biosimilar Insulin Aspart in India, INSUQUICK, for the...
HC allows DCGI to process Reliance's package insert of cancer Pooja Bhatia Bhatia20 Nov 2015 9:45 AM ISTNew Delhi : Delhi High Court today told the Drug Controller General of India (DCGI) that it can process the application of Reliance Life Sciences for...
Hetero strengthens position in India with launch of biosimilar Rituximab Pooja Bhatia Bhatia4 Aug 2015 1:21 PM ISTHetero has launched the drug under the brand name ‘Maball’ to be used for treatment of certain types of cancers and rheumatoid arthritis Drug firm...
