6505--Ustekinumab or Biosimilar Syringes/Vials

PRE-SOLICITATION NOTICE: The VA National Acquisition Center intends to issue Request for Proposal (RFP) 36E79725R0045 for an unrestricted procurement for Ustekinumab Sytinges/Vials, 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 #36E79725R0045 will be electronically issued in commercial item format in accordance with FAR Part 12 on or about July 3, 2025, with a tentative closing date of July 17, 2025. 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 Chris Carthron. Questions can be e-mailed to Christopher.Carthron@va.gov.

The estimated annual requirements are as follows:

REQUIREMENT DESCRIPTION

ITEM

DESCRIPTION

PACKAGE SIZE (Syringe/Vial)

TOTAL ESTIMATED ANNUAL USAGE (Syringes/Vials)

1

USTEKINUMAB 5MG/ML INJ,SOLN,26ML

1

2,917

2

USTEKINUMAB 45MG/0.5ML,0.5ML

1

8,925

3

USTEKINUMAB 90MG/ML INJ,SYR,1ML

1

38,028

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. Additionally, Biosimilars 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/).

For any strength/line item in which the offeror has both syringe and vial available commercially, the offeror must offer both the syringe and vial version for that strength/line item; the syringe and vial must be offered at the same price.