6505--Infliximab Injection 100 mg/vial

PRE-SOLICITATION NOTICE: The VA National Acquisition Center intends to issue Request for Proposal (RFP) 36E79723R0013 for an unrestrictive procurement for Infliximab Injection 100 mg/vial for the Department of Veterans Affairs (VA), Bureau of Prisons (BOP), and Indian Health Service (IHS). The VA will award one contract to the responsible offeror who will be able to provide an uninterrupted source of supply for the contracted item. The contract period will be for one year plus four pre-priced one-year option periods. The contract item will be distributed through the VA s Pharmaceutical Prime Vendor Program. Offerors must state the exact name (name that appears on label) by which the drug will be supplied and have an NDC number that is unique to the offeror. Solicitation 36E79723R0013 will be electronically issued in commercial product format in accordance with FAR Part 12 on or about March 13, 2023, with a tentative closing date of March 28, 2023. The NAICS code for this procurement is 325412. Any future amendments and other miscellaneous documents will be available electronically for download at the following URL: www.sam.gov. No paper copies of the solicitation will be available, and no telephone requests for paper copies of the solicitation will be accepted. Interested offerors are advised to continuously check this URL for any changes to this solicitation. All responsible sources may submit an offer that if timely received, will be considered. The point of contact for this procurement is Deb Fassl. Questions can be e-mailed to: deborah.fassl@va.gov.

The estimated annual requirement is as follows:

ITEM

DESCRIPTION

PACKAGE

SIZE

(VIAL)

TOTAL

ESTIMATED

ANNUAL

USAGE

(VIALS)

1

INFLIXIMAB 100 MG/VIAL INJ * (or Biosimilar Product)

1

169,857

*Proposed biosimilar products must be biological products licensed by the FDA under 42 U.S.C § 262 and must meet all biosimilar criteria described in 42 U.S.C. § 262. Additionally, Biosimilars Products must be FDA approved as a biologic medication that is compared to the innovator (the original biologic) and listed as a biosimilar to the innovator in the FDA Purple Book (https://purplebooksearch.fda.gov/).

** Note Offerors are required to provide individual vials, as indicated in the above table. However, offerors are also to include all other sizes/quantities that are offered commercially (i.e., 10 vials per pack). This requirement does not change the total estimated number of vials (169,857 annual total) for participating agencies.