36E79725R0038_1.docx

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6505--Trastuzumab and Biosimilars
Solicitation number
36E79725R0038
Issued by

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This is a Presolicitation Notice for the Department of Veterans Affairs (VA) National Acquisition Center, seeking proposals for Trastuzumab and Biosimilars. The unrestricted procurement will support multiple federal agencies, including VA, Department of Defense (DoD), Bureau of Prisons (BOP), Indian Health Service (IHS), and Federal Health Care Center (FHCC). The solicitation (36E79725R0038) will be electronically issued on May 21, 2025, with a response deadline of June 4, 2025, at 2:30 PM Central Time.

The contract will award to one responsible offeror capable of providing an uninterrupted supply of two Trastuzumab formulations: 150mg/vial (10,297 estimated annual vials) and 420mg/vial (1,426 estimated annual vials). The contract term is one base year with four additional one-year option periods, and items will be distributed through VA and DoD Pharmaceutical Prime Vendor Programs. Biosimilar products must be FDA-licensed, meet specific criteria, and be listed in the FDA Purple Book. Offerors must provide the exact drug name as it appears on the label and include a unique NDC number.

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Presolicitation Notice Presolicitation Notice

SUBJECT*
Trastuzumab and Biosimilars

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE*
60141
SOLICITATION NUMBER*
36E79725R0038
RESPONSE DATE/TIME/ZONE
06-04-2025 2:30 PM CENTRAL TIME, CHICAGO, USA
ARCHIVE
99 DAYS AFTER THE RESPONSE DATE

SET-ASIDE

PRODUCT SERVICE CODE*
6505
NAICS CODE*
325412

PLACE OF PERFORMANCE

POSTAL CODE

COUNTRY

CONTACT INFORMATION

CONTRACTING OFFICE ADDRESS
Department of Veteran Affairs

OPAL/ National Acquisition Center Building 37 1st Avenue, One block North of Cermak

POINT OF CONTACT*

Contract Specialist Anthony Di Crescenzo anthony.dicrescenzo@va.gov 708-786-4984

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS
anthony.dicrescenzo@va.gov
EMAIL DESCRIPTION
Agency POC email

DESCRIPTION

PRE-SOLICITATION NOTICE: The VA National Acquisition Center intends to issue Request for Proposal (RFP) 36E79725R0038 for an unrestricted procurement for Trastuzumab and Biosimilars, 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.

Solicitation # 36E79725R0038 will be electronically issued in commercial item format in accordance with FAR Part 12 on or about May 21, 2025, with a tentative closing date of June 4, 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 Anthony Di Crescenzo. Questions can be e-mailed to anthony.dicrescenzo@va.gov.

The estimated annual requirements are as follows:

REQUIREMENT DESCRIPTION

ITEM
DESCRIPTION
Package Size

(mg per Vial)

TOTAL EST. ANNUAL USAGE (VIALS)

1
TRASTUZUMAB 150MG/VIL INJ
150
10,297
2
TRASTUZUMAB 420MG/VIL INJ
420
1,426

*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/).

*=Required Field
Presolicitation Notice

Presolicitation Notice

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