6505--Trastuzumab and Biosimilars

Closed Pre-Solicitation Posted

Not the latest version. See the latest solicitation from .

Solicitation number
36E79725R0038
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Veterans Affairs (VA) National Acquisition Center is seeking proposals for Trastuzumab and Biosimilars through an unrestricted procurement (Solicitation #36E79725R0038). The contract will support multiple federal agencies including VA, Department of Defense, Bureau of Prisons, Indian Health Service, and Federal Health Care Center. Offerors must provide the exact drug name as it appears on the label and include a unique NDC number, with biosimilar products required to be FDA-licensed and listed in the FDA Purple Book. The solicitation will be electronically issued on May 21, 2025, with responses due by June 4, 2025, at 2:30 PM Central Time. VA intends to award a single contract to a responsible offeror capable of providing an uninterrupted supply of the specified pharmaceuticals.

The procurement involves two Trastuzumab formulations: 150mg/vial (estimated 10,297 annual vials) and 420mg/vial (estimated 1,426 annual vials). The contract will have a base year with four additional one-year option periods, totaling five potential years of service. Distribution will occur through VA and DoD Pharmaceutical Prime Vendor Programs. There are no specific set-aside designations for this opportunity, making it open to all qualified vendors. The contract will be executed under NAICS code 325412 (Pharmaceutical Preparation Manufacturing) and PSC code 6505 (Drugs and Biologicals). Interested vendors should continuously monitor SAM.gov for any amendments or updates to the solicitation, with all communications directed to Contract Specialist Anthony Di Crescenzo at anthony.dicrescenzo@va.gov.

Notice text

Presolicitation Notice

Presolicitation Notice

Page 3 of 3

Presolicitation Notice

*=Required Field

Presolicitation Notice

Page 1 of 3

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:Â 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).Â

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.Â

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. Â Â

The estimated annual requirements are as follows:Â

REQUIREMENT DESCRIPTIONÂ

ITEMÂ

DESCRIPTIONÂ

Package Size

(mg per Vial)

TOTAL EST. ANNUAL USAGE (VIALS)

1Â

TRASTUZUMAB 150MG/VIL INJ

150

10,297

2Â

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/).

Files

File Type Posted
36E79725R0038_1.docx DOCX document

Notice history

Notice Type Posted
6505--Trastuzumab and Biosimilars (VA-25-00052526) Latest solicitation Solicitation
This notice Original Pre-Solicitation

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