6505-- Denosumab Injections

Amendment / Modification

This amendment (0002) updates the solicitation by incorporating revised language into the Scope of Contract and the Addendum to FAR 52.212-1 Instructions to Offerors. Offerors are instructed to disregard pages 19 and 20 of the previous Amendment 0001. This amendment (0002) includes updated pages 2-6, specifically modifying Section 13 of the Scope of Contract and paragraph 7 of the FAR 52.212-1 Addendum.

• Scope of Contract, Section 13: Updated language regarding manufacturing facilities and place of performance, including detailed requirements for FDA cGMP compliance, facility inspections, and reporting of FDA notifications (e.g., Form FDA 483, Warning Letters). It outlines procedures for handling unacceptable cGMP status and requirements for facility substitutions.
• Addendum to FAR 52.212-1 Instructions to Offerors, Paragraph 7: Revised guidance on Country of Origin and VA's interpretation of substantial transformation of pharmaceuticals. This section clarifies how the country of origin will be determined for TAA compliance, particularly for U.S.-made versus foreign-manufactured pharmaceuticals, and the criteria for substantial transformation. It also specifies the documentation required from offerors to substantiate country of origin claims.

Offerors must use this Amendment 0002, which includes the updated sections. All other solicitation terms and conditions remain unchanged. The amendment does not explicitly state a change to proposal deadlines, but it is critical for offerors to review and comply with the updated requirements regarding manufacturing facilities, cGMP status, and country of origin documentation.

Amendment / Modification

This amendment corrects a previously posted solicitation document that contained inaccurate content due to a system error. Offerors are instructed to disregard the original solicitation and use this amended version. Key changes include:

• Corrected SF-1449: The solicitation includes a corrected Standard Form 1449 (Solicitation/Contract/Order for Commercial Products and Commercial Services) on page 2, which should be completed and signed by offerors.
• Ignore Original Content: Offerors must ignore the original solicitation content and proceed with the amended document.

• The entire original solicitation content is superseded by this amendment.

• The corrected SF-1449 and subsequent pages are now the operative documents.

• Offerors must complete and sign the corrected SF-1449 provided in this amendment.

• All other solicitation terms and conditions remain unchanged.

Solicitation / RFP / RFQ

This solicitation seeks proposals for the supply of Denosumab Injections (60MG and 120MG) to the Department of Veterans Affairs (VA) and Department of Defense (DoD) through their respective Pharmaceutical Prime Vendor (PPV) Programs. The objective is to establish a supply source for these drugs, ensuring availability and consistent product for nationwide usage with volume-based pricing.

• Products: Denosumab 60MG Injection and Denosumab 120MG Injection.

• Packaging: Must be compatible with automated dispensing units. Glass bottles are not acceptable.

• Labeling: Must include a unique 11-digit National Drug Code (NDC) specific to the offeror.

• Barcoding: All pharmaceutical products require bar code labeling at the unit-of-use package level conforming to GS1-128 or HIBCC standards.

• DSCSA Compliance: Adherence to Drug Supply Chain Security Act requirements, including serialized transaction information.

• cGMP Compliance: Manufacturing facilities must have an acceptable cGMP status on record with the FDA.

• Letter of Commitment: Required from non-manufacturers, assuring a sufficient source of supply.

• Contract Type: Firm Fixed Price, Indefinite-Delivery Requirements contract.

• Period of Performance: Base Ordering Period of one year, with four one-year option periods.

• Distribution: Products will be distributed through Government Prime Vendor contract(s).

• Submission Method: Proposals accepted via email to Raymond.roldan@va.gov and Nicholas.mcgregor@va.gov, including a scanned PDF of the signed SF-1449. Faxed proposals are not acceptable.

• Pricing: Offerors must submit prices for the base year and all four option years for both line items. Prices must not exceed two decimal places and must include a 0.5% Cost Recovery Fee.

• Evaluation: Award will be made to the responsible offeror with the lowest price technically acceptable offer. Technical acceptability includes meeting product descriptions, unique NDC, FDA approval, and FDA cGMP compliance.

• Deadline: Offer Due Date is April 28, 2026, at 2:30 PM CDT.

• NAICS Code: 325412

• Size Standard: 1,300 employees.

• Small Business Subcontracting Plan: Required for other than small business concerns if the contract value exceeds $900,000.

• Covered Drugs: Offerors of covered drugs must have an executed Master Agreement (MA) and Pharmaceutical Pricing Agreement (PPA) with the VA FSS, and proposed drugs must be present on the Offeror’s FSS contract or interim agreement.

• One award will be made in the aggregate for line items 1 and 2.

• Offerors must list an 11-digit NDC number unique to their company for each offered drug.

• A 0.5% Cost Recovery Fee is embedded in all offered prices.

• Attachments A and B list the VA and DoD Pharmaceutical Prime Vendor Contractors.

Solicitation / RFP / RFQ

This is a pre-solicitation notice for an unrestricted procurement (RFP 36E79726R0018) for Denosumab Injection. The Department of Veterans Affairs (VA) National Acquisition Center intends to award one contract to a responsible offeror to provide an uninterrupted supply of this medication to the VA (including CMOPs and State Veterans Homes), Department of Defense (DoD), Bureau of Prisons (BOP), Indian Health Service (IHS), and Federal Health Care Center (FHCC).

• Supply of Denosumab 60MG Injection (estimated annual usage: 22,737 vials/syringes).

• Supply of Denosumab 120MG Injection (estimated annual usage: 5,472 vials/syringes).

• Offerors must specify the exact drug name (as it appears on the label) and have a unique NDC number for the supplied drug. The offeror's label with its unique NDC will be the only label permitted on the product.

• The contract items will be distributed through the VA’s and DoD’s respective Pharmaceutical Prime Vendor Programs.

• 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 biosimilar products must be FDA licensed and 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.

• Contract type: Commercial item format, in accordance with FAR Part 12.

• Contract period: One year with four pre-priced one-year option periods.

• Solicitation will be issued electronically around April 17, 2026.

• Tentative response date: May 5, 2026, 2:30 PM Central Time, Chicago, USA.

• No paper copies of the solicitation will be available.

• Interested offerors should continuously monitor SAM.gov for updates.

• All responsible sources may submit an offer.

• Unrestricted procurement.

• NAICS Code: 325412.

• Contracting Office ZIP Code: 60141.

• Point of Contact: Ray Roldan, Contract Specialist, Raymond.Roldan@va.gov, 708-786-4930.