6505--Pylarify 2026 F-18 Injection 512-C60151

Sole Source Justification

This document justifies a sole source acquisition for Pylarify (Piflufolastat F-18) Injection, a radiopharmaceutical used by the Department of Veterans Affairs Medical Center Baltimore (Baltimore VAMHCS) for diagnosing prostate cancer metastatic disease. The acquisition is conducted under the Multiple-Award Schedule Program and is a new firm fixed-price delivery order.

• Procurement of Pylarify (Piflufolastat F-18) Injection.

• The product is a highly specialized radiopharmaceutical and an FDA-approved PSMA (Prostate-Specific Membrane Antigen) positive emission tomography (PET) imaging drug.

• It binds to PSMA, aiding in the detection of prostate cancer lesions.

• Proposed Contractor: PROGENICS PHARMACEUTICALS, INC.

• FSS Contract Number: 36F79725D0093

• Estimated Value: $599,047.52

• Estimated Quantity: 166 units

• Contract Type: Firm Fixed Price Delivery Order

This document is a justification for a sole source award, not a solicitation for proposals. The justification cites GSAM/R 538.7104-3(b)(1)(ii) as the authority, stating that only one source is capable of providing the unique and highly specialized services/supplies required.

• Progenics Pharmaceuticals, Inc. is a small business vendor.

• The justification notes that Progenics Pharmaceuticals, Inc. is the sole manufacturer and authorized supplier of Pylarify, holding patent protection.

• Pylarify has a longer half-life (110 minutes) compared to alternative PSMA agents (e.g., Ga-68 gozetotide with 68 minutes), offering greater flexibility for patient care and reducing the risk of appointment rescheduling.

• Market research confirmed that Progenics Pharmaceuticals, Inc. is the only company that manufactures and distributes Pylarify, and it is FDA approved for this purpose.

• The VA will continue to conduct market research to identify potential additional sources in the future.

Other / Unclassified

This document is a "P03 Sole Source Justification" related to "Pylarify 2026 F-18 Injection 512-C60151". It appears to be a justification for a sole source award, referencing Solicitation Number 36C24526Q0215 and Award Number 36F79725D0093 36C24526N0276.

While not a solicitation or SOW, this document provides context for a specific award. Bidders interested in this opportunity should note that it was awarded on 01-30-2026 to PROGENICS PHARMACEUTICALS INC for $599,047.52. The Product Service Code is 6505 and the NAICS Code is 325412. The contracting office is located in Washington D.C. (ZIP 20420). This justification may indicate that future procurements for this item might also be sole-sourced, which could impact a vendor's ability to compete.