36E79726R0018_1.docx

SUBJECT*

Denosumab Injections

GENERAL INFORMATION

SET-ASIDE

PLACE OF PERFORMANCE

POSTAL CODE

COUNTRY

CONTACT INFORMATION

OPAL/National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines, IL 60141

POINT OF CONTACT*

Contract Specialist Ray Roldan Raymond.Roldan@va.gov 708-786-4930

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

Presolicitation Notice Presolicitation Notice

DESCRIPTION

Presolicitation Notice

PRE-SOLICITATION NOTICE: The VA National Acquisition Center intends to issue Request for Proposal (RFP) 36E79726R0018 for an unrestricted procurement for Denosumab Injection, for the Department of Veterans Affairs (VA) (inclusive of Consolidated Mail Order Pharmacies (CMOPs) and Option 2 State Veterans Homes (SVH)), Department of Defense (DoD), Bureau of Prisons (BOP), Indian Health Service (IHS), and Federal Health Care Center (FHCC).

VA will award one contract to the responsible offeror who will be able to provide an uninterrupted source of supply for the contracted items. The contract period will be for one year plus four pre-priced one-year option periods. The contract items will be distributed through the VA’s and DOD’s respective Pharmaceutical Prime Vendor Programs.

Offerors must state the exact name (name that appears on label) by which the drug will be supplied and have an NDC number that is unique to the offeror. The successful offeror/contractor's label with its unique NDC shall be the only label on the product. Contractors shall not affix their label over another label on the product.

Solicitation # 36E79726R0018 will be electronically issued in commercial item format in accordance with FAR Part 12 on or about April 17, 2026 with a tentative closing date of May 5, 2026. The NAICS code for this procurement is 325412. Any future amendments and other miscellaneous documents will be available electronically for download at sam.gov. No paper copies of the solicitation will be available, and no telephone requests for paper copies of the solicitation will be accepted. Interested offerors are advised to continuously check Contracting Opportunities at SAM.gov for any changes to this solicitation. All responsible sources may submit an offer that if timely received, will be considered. The point of contact for this procurement is Ray Roldan. Questions can be emailed to Raymond.Roldan@va.gov.

The estimated annual requirements are as follows:

Requirement Description

Please note the following:

1. Should a covered drug (as defined in 38 U.S.C. § 8126) be proposed and awarded as a result of any solicitation for these products, both parties (Offeror and VA) understand the VA National Contract Service must have established Federal Ceiling Prices (FCPs) from VA’s Pharmacy Benefits Management (PBM). The parties agree the FCP will be calculated pursuant to the requirements of 38 U.S.C. § 8126 and any related requirements contained in the contractor’s Master Agreement, Pharmaceutical Pricing Agreement, and relevant VA Dear Manufacturer Letters. Refer to the VA Federal Supply Schedule (FSS) website at https://www.fss.va.gov/ and Public Law 102-585 (Veterans Health Care Act of 1992) page on the VA FSS website at https://www.va.gov/opal/nac/fss/publicLaw.asp for further information and a list of published Dear Manufacturer Letters.

Offers of covered drugs (including biologics that fall within 21 CFR § 600.3) will only be considered for award if the Offeror has an executed MA and PPA (which includes the offered NDCs) on file with the VA National Acquisition Center, FSS (in accordance with 38 U.S.C. § 8126(h)(2)). Furthermore, in order to be considered for award under this solicitation, all proposed covered drug product(s) must be present on the Offeror’s FSS contract or interim agreement with an established Permanent FCP associated with the offeror’s FSS contract or interim agreement by this solicitation’s due date and time for receipt of offers. Offers failing to meet these criteria will be rejected and receive no further consideration.

2. Proposed biosimilar products must be biological products licensed by the FDA under 42 U.S.C. § 262 and must meet all biosimilar criteria described in 42 U.S.C. § 262. In addition, biosimilar products must be FDA approved as a biologic medication that is compared to the innovator (the original biologic) and listed as a biosimilar to the innovator in the FDA Purple Book (https://purplebooksearch.fda.gov/).

3. Should an offeror market both a vial and syringe for the same product strength, both products must be included in the offeror’s proposal at the same proposed price. Should the contract awardee not market an alternate presentation (vial or syringe) in the same strength at the time of contract award, but begin marketing an alternate presentation post-award, the new vial or syringe product will be added to the contract at the awarded contract price for the originally proposed vial or syringe in the same strength.