6505--Ustekinumab or Biosimilar Syringes/Vials
ID: 36E79725R0045Type: Solicitation
Overview

Buyer

VETERANS AFFAIRS, DEPARTMENT OFVETERANS AFFAIRS, DEPARTMENT OFNAC PHARMACEUTICALS (36E797)HINES, IL, 60141, USA

NAICS

Pharmaceutical Preparation Manufacturing (325412)

PSC

DRUGS AND BIOLOGICALS (6505)

Original Source

https://sam.gov/opp/6ca38237dd1648fc840290de714c6108/view
Timeline
    Description

    The Department of Veterans Affairs is seeking contractors to supply Ustekinumab or biosimilar syringes and vials as part of its procurement efforts through the National Acquisition Center. The solicitation includes an amendment that increases the estimated annual requirement for one line item from 38,028 to 45,763 units, reflecting the critical need for these pharmaceutical supplies in supporting healthcare services for veterans. This procurement is essential for ensuring compliance with the Drug Supply Chain Security Act and maintaining a reliable supply of necessary medications across various agencies, including the Department of Defense and the Indian Health Service. Interested parties must submit their offers by July 31, 2025, and can contact Contract Specialist Christopher Carthron at Christopher.Carthron@va.gov for further information.

    Point(s) of Contact
    Christopher CarthronContract Specialist
    Christopher.Carthron@va.gov
    Files
    Title
    Posted
    36E79725R0045_1.docx
    The VA National Acquisition Center is set to issue Request for Proposal (RFP) 36E79725R0045 for Ustekinumab syringes/vials, aimed at providing the Department of Veterans Affairs (VA), Department of Defense (DoD), and other federal health services with a consistent supply. The contract's duration is one year with four optional one-year extensions. Offerors must submit a proposal with the specific drug name and unique NDC number, ensuring no labels are placed over existing product labels. The solicitation will be available electronically on or around July 3, 2025, with a response deadline of July 17, 2025. The estimated annual requirements include various package sizes and quantities of Ustekinumab products. Any proposed biosimilar must meet FDA biosimilar criteria and be listed in the FDA Purple Book. Offerors with both syringe and vial options for a given strength must provide both at the same price. The point of contact for queries is Chris Carthron from the VA National Acquisition Center in Hines, IL.
    36E79725R0045.docx
    The document outlines the solicitation for pharmaceutical supplies, specifically for Ustekinumab or biosimilar syringes/vials, by the Department of Veterans Affairs (VA) through its Pharmaceutical Prime Vendor Programs. The contract aims to establish a reliable supply source while ensuring compliance with the Drug Supply Chain Security Act (DSCSA). Offerors are required to submit prices for all line items for the base year and four option years, including a 0.5% Cost Recovery Fee. The contractor must provide unique National Drug Code (NDC) numbers and ensure that all products meet FDA standards and regulations. Additionally, the solicitation details the contractor's obligations regarding manufacturing facilities, labeling requirements, and participant eligibility in the contract. Contractors face penalties for backorders and must maintain business-to-business agreements with designated Prime Vendors. The document emphasizes the evaluation of bids according to federal guidelines and the necessity of providing thorough documentation, including performance metrics and compliance reports. This procurement process reflects the VA's commitment to securing quality medications for its healthcare facilities, ensuring continuous access to essential pharmaceutical products.
    36E79725R0045 0001.docx
    This government document serves as an amendment to solicitation number 36E79725R0045 issued by the Department of Veterans Affairs, specifically the OPAL / National Acquisition Center. The primary purpose of the amendment is to extend the deadline for submitting offers for Ustekinumab syringes/vials. The new due date is now set for July 31, 2025, at 2:30 PM CDT, an extension from the previous deadline of June 30, 2025. All other terms and conditions of the original solicitation remain unchanged. This document outlines the procedural requirements for offerors, including the necessity to acknowledge receipt of the amendment to ensure their offers are considered valid. The amendment underscores the government's intention to allow more time for bidders, which indicates a flexible approach in accommodating potential contractors while maintaining standardized procurement processes. Overall, this extension reflects a commitment to transparency and fairness in the bidding process for government contracts.
    36E79725R0045 0002.docx
    The document outlines Amendment 002 for the federal solicitation 36E79725R0045 related to the procurement of Ustekinumab syringes and vials by the Department of Veterans Affairs. This amendment increases the estimated annual requirements for line item 3 from 38,028 to 45,763 units. Contractors are required to acknowledge receipt of this amendment and provide updated estimates on specified pages. The document includes a breakdown of annual usage estimates by various agencies, including the Department of Defense and the Indian Health Service, across different strengths of the Ustekinumab product. For offerors with both syringe and vial presentations available, they must provide both at the same price. Furthermore, any proposed biosimilar products must meet FDA criteria as outlined in the relevant U.S. Code. This amendment reflects the ongoing contractual modifications typical in federal Requests for Proposals (RFPs) and grants. The document emphasizes compliance and accuracy in reporting updated supply needs to facilitate the procurement process for essential medical supplies.
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    6505--Ustekinumab or Biosimilar Syringes/Vials
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    6505--Ustekinumab or Biosimilar Syringes/Vials
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