Sole Source Fixed Price Contract for the procurement of “Pharmacy Supplies”-to be Sole Sourced to Program Support Center., under Request for Quote FDA-RFQ-2021-1238225

FDA has a requirement to procure “Pharmacy Supplies”-to be Sole Sourced to the Program Support Center., under Request for Quote FDA-RFQ-2021-1238225. The Division of Applied Regulatory Science (DARS) OCP/OTS/CDER is evaluating in vitro and in vivo pharmacokinetic assessment of biosimilarity and evaluating models of toxicity assessment for new drug classes. As part of this process DARS needs to acquire these pharmacy drugs to evaluate their parameters: i. Peg-interferon beta - (Plegridy, 125ug syringe, pk of 2 pens); NDC/NSN = 64406-011-01 ii. Interferon beta - (Avonex, 4 - 30ug pre-filled syringes); NDC/NSN = 59627-333-04 iii. Pegloticase (Krystexxa, 8 mg/ml, 1ml vial); NDC/NSN = 75987-080-10 iv. Alirocumab (Praluent, 75 mg/ml, 1ml syringe); NDC/NSN = 0024-5901-01 v. Reslizumab (Cinqair, 10 mg/ml, 10ml vial); NDC/NSN = 59310-610-31. See attached notice,