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Biocon Biologics Obtains the US Market Launch Date for Bosaya and Aukelso (Biosimilar, Prolia & Xgeva)

Shots: Biocon Biologics & Amgen have entered into a settlement & license agreement, allowing the US launch of Bosaya (60mg/mL, SC, PFS) & Aukelso (70mg/mL, SC, single-dose vial), provisional interchangeable biosimilars to Prolia & Xgeva (denosumab) by Oct 1, 2025 Clinical data showed both biosimilars matched the reference product in quality, safety & efficacy, plus Bosaya…
4 days ago

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Biocon Biologics Receives the FDA’s Approval & Provisional Interchangeability Designation for Aukelso and Bosaya (Biosimilars, Xgeva and Prolia)

Shots: The US FDA has approved & granted provisional interchangeability designation to Aukelso (70mg/mL, SC, single-dose vial) & Bosaya (60mg/mL, SC, PFS), biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) Clinical data showed both biosimilars matched the reference product in quality, safety & efficacy, plus Bosaya was approved with Prolia’s REMS to inform about sev. hypocalcemia…
September 18, 2025

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Joshua Salsi from Biocon Biologics in a Riveting Conversation with PharmaShots
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Unlocking Approval: Joshua Salsi from Biocon Biologics in a Riveting Conversation with PharmaShots 

Shots:  The United States has about 38.4 million people living with diabetes, representing 11.6% of the total population. With growing prevalence, there is a significant unmet need for affordable diabetes medications.  Biocon Biologics recently announced the FDA approval of Kirsty, the first and only interchangeable biosimilar to NovoLog (Insulin Aspart).  Joshua Salsi, the Head of…
September 8, 2025

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Enhancing Accessibility to Medicine: Joshua Salsi from Biocon Biologics in Conversation with PharmaShots 

Shots:  Biocon Biologics’ Yesintek, biosimilar to Stelara, has secured broad market access through inclusion in the formularies of all major pharmacy benefit managers (PBMs)  Yesintek offers strong financial support and a smooth transition process, positioning it as a preferred option for patients needing ustekinumab therapy  Joshua Salsi, Head of North America Commercial at Biocon Biologics,…
August 4, 2025

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NEWS

Biocon Biologics’ Kirsty (Biosimilar, NovoLog) Secures the US FDA’s Approval

Shots: The US FDA has approved Kirsty (100 units/mL), an interchangeable biosimilar of NovoLog (Insulin Aspart) to improve glycemic control in adults & pediatric pts with diabetes mellitus Approval was based on comprehensive analytical, non-clinical, & clinical data, which showed similar efficacy, safety, purity & potency of Kirsty vs NovoLog Kirsty is a rapid-acting human…
July 16, 2025

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Biocon Biologics Receives the EC’s Approval for Vevzuo and Evfraxy (Biosimilars, Xgeva and Prolia)

Shots: The EC has approved Vevzuo & Evfraxy, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) following the CHMP positive opinion in Apr 2025 Approval was based on the comprehensive clinical data, which showed comparable PK, safety, efficacy & immunogenicity of Vevzuo & Evfraxy to the reference product Vevzuo prevents SREs in adults with bone-involved malignancies…
July 4, 2025

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Biocon Biologics
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Biocon Biologics Receives CHMP’s Positive Opinion for Vevzuo and Denosumab BBL (Biosimilars, Xgeva and Prolia)

Shots: The CHMP has recommended Vevzuo & Denosumab BBL (brand name under approval), biosimilars of Xgeva & Prolia (denosumab) Opinion was based on the comprehensive clinical data submitted by Biosimilar Collaborations Ireland (Biocon Biologics’ subsidiary) incl. trials, which showed comparable PK, safety, efficacy & immunogenicity to the reference Denosumab is a mAb that works by targeting…
April 29, 2025

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Biocon Biologics
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Biocon Biologics and Regeneron Settle over Yesafili’s (Biosimilar, Eylea) US Launch

Shots: Biocon Biologics & Regeneron have entered into a settlement & license agreement, allowing the US launch of Yesafili, an interchangeable biosimilar version of Eylea (aflibercept) by H2’26 Yesafili’s FDA approval was supported by analytical, nonclinical & clinical data incl. P-III (INSIGHT) trial assessing Yesafili vs Eylea in DME pts, confirming its similarity in PK,…
April 16, 2025

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