6505-- Denosumab Injections
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Department of Veterans Affairs (VA) is soliciting proposals for Denosumab Injections (60MG and 120MG) to ensure an uninterrupted supply for the VA, Department of Defense (DoD), Bureau of Prisons (BOP), Indian Health Service (IHS), and Federal Health Care Center (FHCC). This is an unrestricted procurement for a Firm Fixed Price, Indefinite-Delivery Requirements contract. Proposals are due April 28, 2026, at 2:30 PM CDT.
Scope of Work
This solicitation seeks to establish a supply source for Denosumab 60MG Injection (estimated annual usage: 22,737 vials/syringes) and Denosumab 120MG Injection (estimated annual usage: 5,472 vials/syringes). Key requirements include:
- Product Specifications: Must be FDA-approved, with biosimilar products listed in the FDA Purple Book. If both vial and syringe presentations are marketed for the same strength, both must be offered at the same price.
- Packaging & Labeling: Packaging must be compatible with automated dispensing units (no glass bottles). Products require bar code labeling at the unit-of-use package level (GS1-128 or HIBCC standards) and must include a unique 11-digit National Drug Code (NDC) specific to the offeror.
- Compliance: Adherence to Drug Supply Chain Security Act (DSCSA) requirements, including serialized transaction information. Manufacturing facilities must have an acceptable cGMP status with the FDA.
- Supply Assurance: Non-manufacturers must provide a Letter of Commitment assuring a sufficient source of supply.
Contract Details
- Contract Type: Firm Fixed Price, Indefinite-Delivery Requirements contract.
- Period of Performance: A one-year base ordering period with four pre-priced one-year option periods.
- Distribution: Products will be distributed through the VA’s and DoD’s Pharmaceutical Prime Vendor Programs.
- Pricing: Offerors must submit prices for the base year and all four option years, not exceeding two decimal places, and including a 0.5% Cost Recovery Fee.
- Award: One award will be made in the aggregate for both line items.
Submission & Evaluation
- Submission Method: Proposals must be submitted via email to Raymond.roldan@va.gov and Nicholas.mcgregor@va.gov. A scanned PDF of the signed SF-1449 is required. Faxed proposals are not accepted.
- Deadline: Offers are due by April 28, 2026, at 2:30 PM CDT.
- Evaluation: Award will be made to the responsible offeror with the Lowest Price Technically Acceptable (LPTA) offer. Technical acceptability includes meeting product descriptions, unique NDC, FDA approval, and FDA cGMP compliance.
Eligibility
- Set-Aside: Unrestricted procurement.
- NAICS Code: 325412, with a size standard of 1,300 employees.
- VA FSS Requirements: For covered drugs, offerors must have an executed Master Agreement (MA) and Pharmaceutical Pricing Agreement (PPA) on file with the VA National Acquisition Center, FSS, with established Federal Ceiling Prices (FCPs) by the solicitation due date. Proposed drugs must be present on the Offeror’s FSS contract or interim agreement.
- Small Business Subcontracting Plan: Required for other than small business concerns if the contract value exceeds $900,000.
Additional Notes
Interested offerors should continuously monitor SAM.gov for any updates.