PIPELINE DRUG LIST continued NAME
MANUFACTURER
DOSAGE FORM
CLINICAL USE
APPROVAL STATUS
FDA APPROVAL
bevacizumab (biosimilar to Genentech’s Avastin)
Centus/AstraZeneca
Brain cancer; Cervical cancer; CRC; NSCLC; Ovarian cancer; RCC
IV
Submitted – BLA
Pending
bevacizumab (biosimilar to Genentech’s Avastin)
Samsung Bioepis/Merck
Brain cancer; Cervical cancer; CRC; NSCLC; Ovarian cancer; RCC
IV
Submitted – BLA
Pending
bevacizumab (biosimilar to Genentech’s Avastin)
Viatris (Mylan)/Biocon
Brain cancer; Cervical cancer; CRC; NSCLC; Ovarian cancer; RCC
IV
Submitted – BLA
Pending
donislecel
Celltrans
T1DM
IV
Submitted – BLA; Orphan Drug
Pending
filgrastim (biosimilar to Amgen’s Neupogen)
Amneal
Neutropenia/leukopenia
IV, SC
Submitted – BLA
Pending
filgrastim (biosimilar to Amgen’s Neupogen)
Apotex
Neutropenia/leukopenia
SC
Submitted – BLA
Pending
pegfilgrastim (biosimilar to Amgen’s Neulasta)
Amneal
Neutropenia/leukopenia
SC
Submitted – BLA
Pending
pegfilgrastim (biosimilar to Amgen’s Neulasta)
Apotex
Neutropenia/leukopenia
SC
Submitted – BLA
Pending
pegfilgrastim (biosimilar to Amgen’s Neulasta)
Merck/Fresenius
Neutropenia/leukopenia
SC
Submitted – BLA
Pending
tramadol
Fortress
Postsurgical pain
IV
Submitted – NDA
Pending
Submitted (Supplementals) dapagliflozin (Farxiga )
AstraZeneca
CKD (with or without T2DM)
Oral
Submitted – sNDA; Breakthrough Therapy; Fast Track; Priority Review
Apr-Jun 2021
eptacog beta (Sevenfact®)
Hema Biologics
Hemophilia A and B (prevention of bleeding related to surgery or invasive procedure)
IV
Submitted – sBLA
Apr-Sep 2021
tenapanor (Ibsrela®)
Ardelyx
Hyperphosphatemia (dialysis-dependent patients)
Oral
Submitted – sNDA
04/29/2021
pirfenidone (Esbriet®)
Genentech
Idiopathic pulmonary fibrosis (unclassified)
Oral
Submitted – sNDA; Breakthrough Therapy; Fast Track; Orphan Drug; Priority Review
May 2021
rimegepant (Nurtec™ ODT)
Biohaven
Migraine prevention
Oral
Submitted – sNDA
May-Jun 2021
zoster vaccine recombinant, adjuvanted (Shingrix)
GlaxoSmithKline
Herpes zoster prevention (ages ≥ 18 years at increased risk)
IM, SC
Submitted – sBLA
May-Jun 2021
teriflunomide (Aubagio®)
Sanofi
MS (pediatrics, relapsing)
Oral
Submitted – sNDA; Priority Review
05/02/2021
nivolumab (Opdivo®)
Bristol-Myers Squibb
Esophageal cancer
IV
Submitted – sBLA; Orphan Drug; Priority Review
05/20/2021
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