6505--Ustekinumab or Biosimilar Syringes/Vials

The Department of Veterans Affairs National Acquisition Center is seeking to procure Ustekinumab or biosimilar pharmaceutical products in three different strengths and formulations: 5mg/ml in 26ml vials, 45mg/0.5ml syringes, and 90mg/ml in 1ml syringes or vials. This solicitation requires offerors to provide both syringe and vial versions for each strength at the same price, with any proposed biosimilar products mandating FDA licensure as biological products meeting specific regulatory criteria. Contractors must demonstrate compliance with current Good Manufacturing Practices and provide unique 11-digit National Drug Codes for each product, along with Letters of Commitment from manufacturers if the offeror is not the direct manufacturer. The contract structure includes a base year plus four one-year option periods, with pricing submissions required for each period and not exceeding two decimal places plus a 0.5% Cost Recovery Fee. The solicitation deadline has been extended to July 31, 2025 at 2:30 PM CDT, with proposals required to be submitted via email to the contracting officer.

This procurement is designated as a small business set-aside with a size standard of 1,300 employees and falls under NAICS code 325412 for Pharmaceutical Preparation Manufacturing. The estimated annual usage spans multiple federal agencies including the VA, Department of Defense, Bureau of Prisons, and Indian Health Service, with quantities totaling 2,917 units for the 5mg/ml formulation, 8,925 units for the 45mg/0.5ml formulation, and 45,763 units for the 90mg/ml formulation (recently updated from 38,028 units). The VA will award one contract in the aggregate to cover all three line items across all participating agencies. Distribution will occur through VA and DoD Pharmaceutical Prime Vendors, though the specific contract effective date remains to be determined by the Contracting Officer. No incumbent contractors or specific award values are identified in the available documentation.