MedPath

FDA Approves Subcutaneous Opdivo, Extending BMS Franchise Life

• The FDA has approved a subcutaneous formulation of Opdivo (nivolumab), named Opdivo Qvantig, providing a new administration option for patients. • This approval is strategically important for Bristol Myers Squibb (BMS) as it aims to maintain revenue streams beyond the expected 2028 loss of exclusivity for intravenous Opdivo. • Opdivo Qvantig offers a more convenient delivery method, potentially improving patient experience and adherence to treatment regimens. • The subcutaneous formulation is expected to face biosimilar competition starting in 2029, similar to the intravenous version, impacting long-term market dynamics.

The U.S. Food and Drug Administration (FDA) has approved a subcutaneous formulation of nivolumab, marketed as Opdivo Qvantig, marking a significant development for Bristol Myers Squibb (BMS). This approval extends the lifecycle of the key BMS franchise into the 2030s, providing a new delivery method for this widely used immunotherapy.

Strategic Importance for BMS

With the exclusivity for intravenous Opdivo set to expire in 2028, the introduction of Opdivo Qvantig is a strategic move by BMS to retain a portion of its revenue. The subcutaneous formulation is expected to help offset the impact of biosimilars for the intravenous version, which are anticipated to enter the market in 2029.

Convenience and Patient Adherence

Opdivo Qvantig offers a more convenient administration route compared to the traditional intravenous infusion. Subcutaneous injections can reduce the time spent in healthcare facilities, potentially improving patient adherence and overall treatment experience. This shift towards patient-friendly formulations aligns with the growing trend of value-based healthcare, where patient convenience and quality of life are increasingly important factors.

Market Dynamics and Competition

Despite the strategic advantages, Opdivo Qvantig will eventually face biosimilar competition, similar to its intravenous counterpart. The entry of biosimilars in 2029 will likely impact the market share and pricing of Opdivo Qvantig, necessitating ongoing innovation and market strategies from BMS to maintain its competitive edge.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Silver Bullet Therapeutics Receives FDA Approval for OrthoFuzIon Bone Screw System Pre-Market Study

Silver Bullet Therapeutics has received FDA approval to begin a pre-market 510k study for its OrthoFuzIon Bone Screw System.
The study will evaluate the impact of the silver-platinum coating on orthopedic healing in patients with lateral malleolus fractures.

FDA Awards Breakthrough Status to Pfizer's Group B Strep Vaccine

The FDA has granted breakthrough status to Pfizer's Group B Streptococcus (GBS) vaccine, based on promising phase 2 data. This vaccine aims to protect newborns and young infants from invasive infections by immunizing expectant mothers. GBS is a leading cause of life-threatening infections in newborns, and the breakthrough status could expedite the vaccine's regulatory review process.

FDA Approves Subcutaneous Opdivo Qvantig for Multiple Solid Tumors

The FDA approved Opdivo Qvantig, a subcutaneous injection of nivolumab, for adult solid tumors previously approved for intravenous Opdivo.
CheckMate-67T trial data showed non-inferior pharmacokinetic exposures, similar efficacy, and comparable safety to intravenous Opdivo.

Merit Medical's WRAPSODY Endoprosthesis Receives FDA Approval for Dialysis Patients

Merit Medical's WRAPSODY Cell-Impermeable Endoprosthesis receives FDA premarket approval, paving the way for its commercial launch in the U.S. in 2025.
The WRAPSODY device is designed to extend long-term vessel patency in dialysis patients by addressing stenosis and thrombosis in arteriovenous (AV) fistulas and grafts.

NEXT BIOMEDICAL's Nexpowder Receives FDA Approval for Lower GI Bleeding

NEXT BIOMEDICAL's Nexpowder has gained FDA approval for use in lower gastrointestinal (GI) bleeding, expanding its indication from the upper GI tract.
Nexpowder-S, a next-generation version incorporating sucralfate, has also been approved by the MFDS in Korea, enhancing its performance and efficacy.

MVITRO's ORTIV Receives FDA Clearance for Needle-Free Blood Sampling

MVITRO's ORTIV, a laser-based device for painless blood sampling and glucose monitoring, has secured FDA 510(k) clearance, marking a significant advancement in diabetes management.
ORTIV utilizes micro-lasers to minimize skin damage and eliminate infection risks, offering real-time glucose readings via a dedicated app, addressing the stress of traditional blood sampling.

Subcutaneous Keytruda Shows Comparable Efficacy to IV Formulation in Phase 3 Trial

Merck's subcutaneous formulation of Keytruda demonstrated similar drug levels in the blood compared to the intravenous version in a Phase 3 trial for non-small cell lung cancer.
The study met its primary endpoint, showing comparable blood concentrations between the subcutaneous and IV formulations at various time points.

PL Developments Receives FDA Approval for Over-the-Counter Omeprazole

PL Developments (PLD) has secured FDA approval for its over-the-counter omeprazole magnesium tablet, comparable to Prilosec OTC.
PLD will manufacture the omeprazole OTC product in its Miami facility, becoming the only U.S.-based provider.

FDA Approves New Intravenous Formulation of Ustekinumab Biosimilar SELARSDI™

The FDA has approved a new intravenous formulation of SELARSDI™ (ustekinumab-aekn), a biosimilar to STELARA® (ustekinumab), expanding its potential use.
This new presentation of SELARSDI™, a 130 mg/26 mL single-dose vial for intravenous infusion, complements the existing subcutaneous injection formulations.

SpineGuard's PsiFGuard Receives FDA Clearance for Sacroiliac Joint Fusion

SpineGuard's PsiFGuard, a smart drilling device for posterior sacroiliac fusion (PsiF), has received FDA 510(k) clearance for commercial use in the United States.
The PsiFGuard device utilizes SpineGuard's Dynamic Surgical Guidance (DSG®) technology to enhance the accuracy of implant placement in SI joint fusion procedures.

Reference News

[1]
US FDA Approves Subcutaneous Opdivo, Extending Key BMS Franchise Into 2030s
insights.citeline.com · Dec 27, 2024

US FDA approves subcutaneous Opdivo, ensuring BMS's revenue stream post-2028 exclusivity loss, with biosimilars for the ...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy