6505--Ustekinumab Pens/Syringes or Biosimilar

Solicitation / RFP / RFQ

This solicitation seeks proposals for the supply of Ustekinumab (brand name or biosimilar) injectable solutions in syringes and vials. The contract will support pharmaceutical prime vendor programs for the Department of Veterans Affairs (VA) and the Department of Defense (DoD), as well as other government agencies including the Indian Health Service (IHS) and Bureau of Prisons (BOP).

• Products: Ustekinumab 5mg/mL (26mL syringe/vial), Ustekinumab 45mg/0.5mL (0.5mL syringe/vial), and Ustekinumab 90mg/mL (1mL syringe/vial).

• Packaging: Syringes must be individually boxed. Offerors must offer both syringe and vial versions if commercially available for a given strength, at the same price.

• Compliance: Products must be FDA-approved. Manufacturing facilities must have acceptable cGMP status with the FDA. Offerors must provide unique 11-digit National Drug Code (NDC) numbers for each product.

• Biosimilars: Proposed biosimilar products must be licensed by the FDA under 42 U.S.C § 262 and listed in the FDA Purple Book.

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

• DSCSA: Compliance with the Drug Supply Chain Security Act (DSCSA) is required, including serialized transaction information and statements.

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

• Period of Performance: Includes an Implementation Period (max 60 days), a Base Ordering Period (1 year), and four (4) one-year option periods.

• Distribution: Products will be distributed through Government Pharmaceutical Prime Vendor (PPV) contracts.

• Submission: Proposals must be submitted via email in Microsoft Word or PDF format, including a scanned PDF of the signed SF-1449. Faxed proposals are not acceptable. Offerors must confirm receipt of attachments.

• Pricing: Offerors must submit prices for the base year and all four option years for all three line items. Prices must include a 0.5% Cost Recovery Fee.

• Evaluation: Award will be made to the responsible offeror with the lowest price technically acceptable (LPTA) offer. Technical acceptability includes meeting product descriptions, FDA approval, cGMP compliance, and verifiable FDA clearance for manufacturing facilities.

• Deadline: Offer Due Date is January 26, 2026, at 2:30 PM CT.

• NAICS Code: 325412 (Pharmaceutical Preparation Manufacturing).

• Size Standard: 1,300 employees.

• Subcontracting Plan: Required for other than small business concerns for contracts over $900,000.

• Covered Drugs: Offers of covered drugs must have a Master Agreement (MA) and Pharmaceutical Pricing Agreement (PPA) with the VA FSS, and proposed products must be on the Offeror's FSS contract with an established Permanent FCP.

• Offerors must provide a Letter of Commitment from the manufacturer if not the manufacturer themselves.

• A 0.5% Cost Recovery Fee is embedded in all offered prices and must be reported quarterly.

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

Solicitation / RFP / RFQ

This is a pre-solicitation notice for Request for Proposal (RFP) #36E79726R0006 for Ustekinumab Pen/Syringes or Biosimilar. The Department of Veterans Affairs (VA) National Acquisition Center intends to procure an uninterrupted source of supply for these items for various federal agencies including VA (CMOPs and SVH), Department of Defense (DoD), Bureau of Prisons (BOP), Indian Health Service (IHS), and Federal Health Care Center (FHCC).

• The contract will cover Ustekinumab Pen/Syringes or Biosimilar.

• Offerors must specify the exact drug name (as it appears on the label) and have a unique NDC number for the product they will supply.

• The successful offeror's label with its unique NDC will be the only one permitted on the product; labels cannot be affixed over existing ones.

• Proposed biosimilar products must be FDA licensed under 42 U.S.C § 262, meet biosimilar criteria, and be listed as a biosimilar to the innovator in the FDA Purple Book.

• If an offeror has both syringe and vial versions available commercially for a specific strength, both must be offered at the same price.

• The contract period will be for one year with four pre-priced one-year option periods.

• Distribution will be through the VA’s and DOD’s respective Pharmaceutical Prime Vendor Programs.

• Estimated annual requirements are provided for three line items:

  • Item 1: USTEKINUMAB 5MG/ML INJ,SOLN,26ML (2,917 units)
  • Item 2: USTEKINUMAB 45MG/0.5ML,0.5ML (9,608 units)
  • Item 3: USTEKINUMAB 90MG/ML INJ,SYR,1ML (45,763 units)

• The solicitation will be issued electronically in accordance with FAR Part 12.

• Expected issuance date: on or about January 12, 2026.

• Tentative closing date: January 27, 2026.

• The NAICS code is 325412.

• All responsible sources may submit an offer; timely received offers will be considered.

• This is an unrestricted procurement.

• No paper copies of the solicitation will be available. Interested offerors should monitor SAM.gov for updates.

• Point of Contact: Chris Carthron (Christopher.Carthron@va.gov, (708) 786-4980).