News about "Biocon Biologics"

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

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

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 |  122

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 |  115

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 |  168

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 |  305

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 |  294

Biocon Biologics Gets EMA Approval for Bevacizumab and its New mAbs Facility in India

Biocon Biologics Ltd. has received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its new, world-class, multi-product monoclonal antibodies (mAbs) drug substance facility in Bengaluru.

Biocon Biologics | 24/06/2024 | By Aishwarya |  775

Biocon Biologics Gets FDA Approval for Biosimilar Aflibercept for Yesafili

Biocon Biologics Ltd (BBL) has announced that the US Food and Drug Administration (US FDA) has approved the company’s first-to-file application for Yesafili.

Biocon Biologics | 21/05/2024 | By Aishwarya |  240

Eris Lifesciences Announces Acquisition of Biocon Biologics

Eris Lifesciences Ltd. has recently acquired Biocon Biologics’ Branded Formulations business in India in a deal worth INR 1,242 crore.

Biocon Biologics | 19/03/2024 | By Manvi |  387