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), through its NAC PHARMACEUTICALS office, is soliciting proposals for Ustekinumab Pens/Syringes or Biosimilar under RFP #36E79726R0006. This unrestricted procurement aims to secure an uninterrupted supply of these drugs for various federal agencies, including the VA, Department of Defense (DoD), Bureau of Prisons (BOP), Indian Health Service (IHS), and Federal Health Care Center (FHCC). The contract will be a Firm Fixed Price, Indefinite-Delivery Requirements type. Offers are due by February 10, 2026, at 2:30 PM CST.
Scope of Work & Key Requirements
The solicitation seeks Ustekinumab in specific formulations: 5mg/mL (26mL), 45mg/0.5mL (0.5mL), and 90mg/mL (1mL) in syringe/vial formats. Key requirements include:
- Products must be FDA-approved, with manufacturing facilities holding acceptable cGMP status.
- Offerors must provide unique 11-digit National Drug Code (NDC) numbers for each product.
- Proposed biosimilar products must be FDA licensed under 42 U.S.C § 262 and listed in the FDA Purple Book.
- If both syringe and vial versions are commercially available for a strength, both must be offered at the same price.
- All pharmaceutical products require bar code labeling (GS1-128 or HIBCC) at the unit-of-use package level and compliance with the Drug Supply Chain Security Act (DSCSA).
- Offerors must provide a Letter of Commitment from the manufacturer if they are not the manufacturer.
Contract Details
- Contract Type: Firm Fixed Price, Indefinite-Delivery Requirements.
- Period of Performance: An implementation period (max 60 days), a one-year base ordering period, and four (4) one-year option periods.
- Distribution: Through the VA’s and DoD’s Pharmaceutical Prime Vendor Programs.
- NAICS Code: 325412 (Pharmaceutical Preparation Manufacturing) with a 1,300-employee size standard.
- Eligibility: 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.
Submission & Evaluation
- Submission: Proposals must be submitted via email in Microsoft Word or PDF format, including a scanned PDF of the signed SF-1449.
- 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.
Amendments & Deadline
This solicitation has been amended twice. The latest amendment (0002) extends the offer due date to February 10, 2026, at 2:30 PM Central Standard Time (CST). All other terms and conditions of the original solicitation remain unchanged.