News about "Biocon Biologics"

Biocon Biologics and Civica Launch Private-Label Insulin Glargine in the US

The multi-year transformational agreement between Biocon Biologics and Civica creates an exclusive distributorship arrangement where Biocon Biologics will manufacture and supply Insulin Glargine medicine to Civica, and Civica will commercialise under Biocon Biologics’ existing marketing approval.

Biocon Biologics | 21/10/2025 | By Dineshwori

Biocon and Carnegie Secure Tentative FDA Approval for Rifaximin Tablets

Biocon Pharma, a wholly owned subsidiary of Biocon Ltd., in partnership with Carnegie Pharmaceuticals, has received tentative approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg.

Biocon Biologics | 07/10/2025 | By Dineshwori |  127

Biocon Biologics, Amgen Settle Patent Dispute, Paving Way for US Launch of Denosumab Biosimilars

The agreement with Amgen enables Biocon Biologics to launch denosumab biosimilars Bosaya and Aukelso in the US from October 1, 2025.

Biocon Biologics | 01/10/2025 | By Dineshwori |  239

Biocon Biologics Secures US FDA Approval for Denosumab Biosimilars Bosaya and Aukelso

The US Food and Drug Administration (FDA) has approved Biocon Biologics' denosumab biosimilars, Bosaya (denosumab-kyqq) 60 mg/mL injection in a single-dose prefilled syringe (PFS) and Aukelso (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection in a single-dose vial, biosimilars of Prolia and Xgeva, respectively.

Biocon Biologics | 17/09/2025 | By Dineshwori |  346

Biocon Biologics Secures FDA Approval for Kirsty

Biocon Biologics has announced that it has received FDA approval for KIRSTY (Insulin Aspart-xjhz), making it the first and only interchangeable biosimilar to NovoLog in the US, marking a major milestone in expanding affordable insulin options.

Biocon Biologics | 16/07/2025 | By Mrinmoy Dey |  169

Biocon Biologics Receives European Commission Nod for Denosumab Biosimilars to Improve Bone Health

Biocon Biologics has received European Commission approval for its Denosumab biosimilars, Vevzuo and Evfraxy, thereby expanding access to advanced treatments for bone-related conditions across the EU.

Biocon Biologics | 03/07/2025 | By Mrinmoy Dey |  155

Biocon Biologics Scales Up Insulin Access in Malaysia

Biocon Biologics has announced that its Malaysian subsidiary has crossed the milestone of supplying over 100 million recombinant human insulin cartridges to Malaysia’s Ministry of Health, reinforcing its commitment to affordable and accessible diabetes care.

Biocon Biologics | 30/06/2025 | By Mrinmoy Dey |  159

Biocon Biologics and Civica to Expand Insulin Aspart Access in US

Civica will commercialize the medicine for patients in the United States, after completion of development work and clinical trials. No technology transfer is involved in the agreement.

Biocon Biologics | 10/03/2025 | By Aishwarya |  261

Biocon Biologics' Report Offers Insights on Increasing Biosimilars Adoption in LMICs

Biocon Biologics commissioned the study, defined the methodology and collaborated with Clarivate to develop the final report.

Biocon Biologics | 09/10/2024 | By Aishwarya |  384

Biocon Biologics Signs License Deal with Janssen for Bmab 1200

Under the terms of this settlement agreement, Biocon Biologics has resolved patent disputes with Janssen to secure market entry dates in Europe, the UK, Canada, and Japan. Regulatory filings in these markets are currently under review.

Biocon Biologics | 29/08/2024 | By Aishwarya |  357