6505--Ustekinumab Pens/Syringes or Biosimilar
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Department of Veterans Affairs (VA), National Acquisition Center, is soliciting proposals for the supply of Ustekinumab Pens/Syringes or Biosimilar under a Firm Fixed Price, Indefinite-Delivery Requirements contract. This procurement aims to secure an uninterrupted source of supply for various federal agencies, including VA, DoD, Bureau of Prisons (BOP), and Indian Health Service (IHS). Proposals are due January 26, 2026, at 2:30 PM CT.
Scope of Work
This solicitation covers the supply of Ustekinumab injectable solutions in syringes and vials. Key products include:
- Ustekinumab 5mg/mL (26mL syringe/vial)
- Ustekinumab 45mg/0.5mL (0.5mL syringe/vial)
- Ustekinumab 90mg/mL (1mL syringe/vial)
Offerors must provide both syringe and vial versions if commercially available for a specific strength, at the same price. All products must be FDA-approved, and manufacturing facilities must maintain acceptable cGMP status. Each product requires a unique 11-digit National Drug Code (NDC) and bar code labeling at the unit-of-use level (GS1-128 or HIBCC standards). Compliance with the Drug Supply Chain Security Act (DSCSA) is mandatory. Proposed biosimilar products must be FDA licensed under 42 U.S.C § 262 and listed in the FDA Purple Book.
Contract Details
- Contract Type: Firm Fixed Price, Indefinite-Delivery Requirements (IDR).
- Period of Performance: An Implementation Period (max 60 days), a Base Ordering Period of one year, and four (4) one-year option periods.
- Distribution: Products will be distributed through the Government Pharmaceutical Prime Vendor (PPV) programs for VA and DoD.
- Estimated Annual Requirements:
- 5mg/mL (26mL): 2,917 units
- 45mg/0.5mL (0.5mL): 9,608 units
- 90mg/mL (1mL): 45,763 units
Eligibility & Set-Aside
- Set-Aside: This is an unrestricted procurement. All responsible sources may submit an offer.
- NAICS Code: 325412 (Pharmaceutical Preparation Manufacturing) with a size standard of 1,300 employees.
- Subcontracting Plan: Required for other than small business concerns for contracts exceeding $900,000.
- Covered Drugs: Offerors 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. A Letter of Commitment from the manufacturer is required if the offeror is not the manufacturer.
Submission & Evaluation
- 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 accepted. Offerors should confirm receipt of attachments.
- Pricing: Offerors must submit prices for the base year and all four option years for all three line items, including 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.
Key Dates & Contact
- Proposal Due Date: January 26, 2026, at 2:30 PM CT.
- Published Date: January 9, 2026.
- Point of Contact: Christopher Carthron, Contract Specialist, Christopher.Carthron@va.gov, (708) 786-4980.