FDA Approvals of Novel Brand-Name Prescription Drugs in 2018

March 2019, Vol 12, Tenth Annual Payers' Guide - Drug Updates, FDA Approvals, Payers' Guide
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I. New Molecular Entities and New Biologic License Applications

Aemcolo (NME)
(Rifamycin; Cosmo Technologies/Aries Pharmaceuticals)
Class/route: Antibacterial drug; delayed-release oral tablets
Indication: For treatment of adults with traveler’s diarrhea that is caused by noninvasive Escherichia coli strains and is not complicated by fever or blood in the stool
Limitations of use: Not indicated for diarrhea complicated by fever or bloody stool or from pathogens other than noninvasive strains of Escherichia coli
Approval considerations: Fast track, priority review
Approval date: November 16, 2018

Aimovig (BLA)
(Erenumab-aooe; Amgen)
Class/route: First-in-class calcitonin gene-related peptide receptor antagonist; subcutaneous injection
Indication: For the prevention of migraine in adults
Approval date: May 17, 2018

Ajovy (BLA)
(Fremanezumab-vfrm; Teva)
Class/route: Calcitonin gene-related peptide antagonist; subcutaneous injection
Indication: For the prevention of migraine in adults
Approval considerations: Priority review
Approval date: September 14, 2018

Akynzeo (NME)
(Fosnetupitant and palonosetron; Helsinn)
Class/route: Serotonin-3 receptor antagonist and substance P/neurokinin-1 receptor antagonist; intravenous injection
Indication: For the prevention, in combination with dexamethasone, of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy in adults: palonosetron prevents nausea and vomiting during the acute phase; fosnetupitant (a prodrug of netupitant) prevents nausea and vomiting during the acute and the delayed phases after chemotherapy
Limitations of use: This agent has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy
Approval considerations: Akynzeo (netupitant and palonosetron) oral capsules were initially approved in 2014 for the same indication
Approval date: April 19, 2018

Annovera (NME)
(Segesterone acetate and ethinyl estradiol; Population Council)
Class/route: Progestin plus estrogen combination hormonal contraception; vaginal system
Indication: To prevent pregnancy in females of reproductive potential
Limitations of use: Not adequately evaluated in females with a body mass index of >29 kg/m2
Approval date: August 10, 2018

Asparlas (BLA)
(Calaspargase pegol-mknl; Servier Pharmaceuticals)
Class/route: L-asparaginase; intravenous injection
Indication: For treatment of acute lymphoblastic leukemia, as part of a chemotherapeutic regimen, in patients aged 1 month to 21 years
Approval considerations: Orphan drug
Approval date: December 20, 2018

Biktarvy (NME)
(Bictegravir, emtricitabine, and tenofovir alafenamide; Gilead Sciences)
Class/route: ISTI and 2 NRTIs; oral tablets
Indications: For treatment of HIV-1 infection, as a complete regimen, in adults who have not received antiretroviral therapy, and to replace current antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA <50 copies per mL) while receiving a stable antiretroviral regimen for ≥3 months and have no history of treatment failure or no known substitutions associated with resistance to the individual components of this regimen
Approval considerations: Priority review
Approval date: February 7, 2018

Braftovi (NME)
(Encorafenib; Array BioPharma)
Class/route: Kinase inhibitor targeting BRAF V600E; oral capsules
Indication: For treatment, in combination with binimetinib (Mektovi), of patients with unresectable or metastatic melanoma and a BRAF V600E or V600K mutation, as detected by an FDA-approved test
Limitations of use: Not indicated for BRAF wild-type melanoma
Approval considerations: Orphan drug
Approval date: June 27, 2018

Copiktra (NME)
(Duvelisib; Verastem)
Class/route: Dual kinase inhibitor of PI3K-delta and PI3K-gamma; oral capsules
Indications: For treatment of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least 2 previous therapies; relapsed or refractory follicular lymphoma after at least 2 previous systemic therapies
Approval considerations: Accelerated approval, fast track, orphan drug, priority review; REMS program
Approval date: September 24, 2018

Crysvita (NME)
(Burosumab-twza; Kyowa Kirin/Ultragenyx Pharmaceutical)
Class/route: First-in-class fibroblast growth factor
23–blocking antibody; subcutaneous injection
Indication: For treatment of X-linked hypophosphatemia in patients aged ≥1 year
Approval considerations: Breakthrough therapy, fast track, orphan drug, priority review
Approval date: April 17, 2018

Daurismo (NME)
(Glasdegib; Pfizer)
Class/route: Hedgehog pathway inhibitor; oral tablets
Indications: For treatment, in combination with low-dose cytarabine, of newly diagnosed AML in adults aged ≥75 years; and for patients with AML who have comorbidities that preclude the use of intensive induction chemotherapy
Limitations of use: Has not been studied in severe renal impairment or moderate-to-severe hepatic impairment
Approval considerations: Orphan drug, priority review
Approval date: November 21, 2018

Diacomit (NME)
(Stiripentol; Biocodex)
Class/route: Anticonvulsant drug; oral capsules and oral suspension powder
Indication: For treatment, in combination with clobazam, of seizures associated with Dravet syndrome in patients aged ≥2 years
Approval considerations: Orphan drug, priority review
Approval date: August 20, 2018

Doptelet (NME)
(Avatrombopag; AkaRx/Dova Pharmaceuticals)
Class/route: Thrombopoietin receptor agonist; oral tablets
Indication: For the treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical procedure
Approval considerations: Priority review
Approval date: May 21, 2018

Elzonris (BLA)
(Tagraxofusp-erzs; Stemline Therapeutics)
Class/route: First-in-class CD123-directed cytotoxin; intravenous injection
Indication: For treatment of blastic plasmacytoid dendritic-cell neoplasm in patients aged ≥2 years
Approval considerations: Breakthrough therapy, orphan drug, priority review
Approval date: December 21, 2018

Emgality (NME)
(Galcanezumab-gnlm; Eli Lilly)
Class/route: Humanized monoclonal antibody specific to calcitonin gene-related peptide ligand; subcutaneous injection
Indication: For preventive treatment of migraine in adults
Approval date: September 27, 2018

Epidiolex (NME)
(Cannabidiol; Greenwich Biosciences)
Class/route: Cannabinoid; oral solution
Indication: For treatment of seizures associated with 2 rare forms of epilepsy—Lennox-Gastaut syndrome and Dravet syndrome—in patients aged ≥2 years; this is the first drug approved for the treatment of Dravet syndrome
Approval considerations: Fast track, orphan drug, priority review
Approval date: June 25, 2018

Erleada (NME)
(Apalutamide; Janssen)
Class/route: Androgen receptor inhibitor; oral tablets
Indication: For the treatment of patients with nonmetastatic castration-resistant prostate cancer
Approval considerations: Fast track, priority review; this was the first time the FDA used the end point of metastasis-free survival to approve a drug
Approval date: February 14, 2018

Firdapse (NME)
(Amifampridine; Catalyst Pharmaceuticals)
Class/route: Potassium channel blocker; oral tablets
Indication: For the treatment of Lambert-Eaton myasthenic syndrome (a rare autoimmune disorder)
in adults
Approval considerations: Breakthrough therapy, orphan drug, priority review
Approval date: November 28, 2018

Galafold (NME)
(Migalastat; Amicus Therapeutics)
Class/route: First-in-class alpha-galactosidase A pharmacological chaperone; oral capsules
Indication: For treatment of adults with a confirmed diagnosis of Fabry disease and a GLA gene variant, based on in vitro assay data
Approval considerations: Accelerated approval, fast track, orphan drug, priority review
Approval date: August 10, 2018

Gamifant (NME)
(Emapalumab-lzsg; Novimmune/Sobi)
Class/route: First-in-class interferon gamma–blocking antibody; intravenous injection
Indications: For treatment of patients with primary hemophagocytic lymphohistiocytosis whose disease is refractory, recurrent, or progressive; and for patients who are intolerant to conventional hemophagocytic lymphohistiocytosis therapy
Approval considerations: Breakthrough therapy, orphan drug, priority review
Approval date: November 20, 2018

Ilumya (NME)
(Tildrakizumab-asmn; Sun Pharma)
Class/route: IL-23 antagonist; subcutaneous injection
Indication: For treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
Approval date: March 21, 2018

Krintafel (NME)
(Tafenoquine; GlaxoSmithKline)
Class/route: An 8-aminoquinoline antimalarial drug; oral tablets
Indication: For the radical cure (ie, prevention of relapse) of Plasmodium vivax malaria in patients aged ≥16 years who are receiving appropriate antimalarial therapy for acute P vivax infection
Limitations of use: Not indicated for treatment of acute P vivax malaria
Approval considerations: Breakthrough therapy, orphan drug, priority review
Approval date: July 20, 2018

Libtayo (BLA)
(Cemiplimab-rwlc; Regeneron/Sanofi)
Class/route: PD-1–blocking antibody; intravenous injection
Indication: For treatment of patients with locally advanced or metastatic cutaneous squamous-cell carcinoma who are not candidates for curative surgery or curative radiation
Approval considerations: Breakthrough therapy, priority review
Approval date: September 28, 2018

Lokelma (NME)
(Sodium zirconium cyclosilicate; AstraZeneca)
Class/route: Potassium binder; powder for oral suspension
Indication: For treatment of hyperkalemia in adults
Limitations of use: Should not be used as an emergency treatment for life-threatening hyperkalemia, because of its delayed onset of action
Approval date: May 18, 2018

Lorbrena (NME)
(Lorlatinib; Pfizer)
Class/route: Kinase (ALK) inhibitor; oral tablets
Indications: For treatment of patients with metastatic NSCLC and ALK mutation whose disease progressed during treatment with crizotinib and at least 1 other ALK inhibitor for metastatic disease, or for those whose disease progressed during treatment with alectinib as the first ALK inhibitor used for metastatic disease, or with ceritinib as the first ALK inhibitor used for metastatic disease
Approval considerations: Accelerated approval, break­through therapy, orphan drug, priority review
Approval date: November 2, 2018

Lucemyra (NME)
(Lofexidine; US WorldMeds)
Class/route: First-in-class central alpha-2 adrenergic agonist; oral tablets
Indication: For mitigation of opioid withdrawal symptoms in adults, to facilitate abrupt discontinuation of opioid therapy
Limitations of use: Not indicated for the treatment of opioid use disorder
Approval considerations: Fast track, priority review
Approval date: May 16, 2018

Lumoxiti (BLA)
(Moxetumomab pasudotox-tdfk; AstraZeneca)
Class/route: CD22-directed cytotoxin; intravenous injection
Indication: For treatment of adults with relapsed or refractory hairy-cell leukemia who have received at least 2 systemic therapies, including a purine nucleoside analog; it is the first CD22-directed cytotoxin approved for this indication
Limitations of use: Not recommended for patients
with severe renal impairment (creatinine clearance
≤29 mL/min)
Approval considerations: Fast track, orphan drug, priority review
Approval date: September 13, 2018

Lutathera (NME)
(Lutetium Lu 177 dotatate; Advanced Accelerator Applications)
Class/route: First-in-class radiolabeled somatostatin analog; intravenous injection
Indication: For treatment of somatostatin receptor–positive gastroenteropancreatic NETs, including foregut, midgut, and hindgut NETs in adults
Approval considerations: Fast track, orphan drug, priority review
Approval date: January 26, 2018

Mektovi (NME)
(Binimetinib; Array BioPharma)
Class/route: Kinase inhibitor; oral tablets
Indication: For treatment, in combination with encorafenib (Braftovi), of patients with unresectable or metastatic melanoma and a BRAF V600E or V600K mutation, as detected by an FDA-approved test
Approval considerations: Orphan drug
Approval date: June 27, 2018

Motegrity (NME)
(Prucalopride; Shire US)
Class/route: Serotonin type 4 receptor agonist; oral tablets
Indication: For treatment of chronic idiopathic constipation in adults
Approval date: December 14, 2018

Moxidectin (NME)
(Approved with no trade name; Medicines Development for Global Health)
Class/route: A macrocyclic lactone, anthelmintic drug; oral tablets
Indication: For treatment of onchocerciasis caused by Onchocerca volvulus in patients aged ≥12 years
Limitations of use: Moxidectin tablets do not kill
O volvulus parasites; the safety and efficacy of repeated use is unknown
Approval considerations: Orphan drug, priority review
Approval date: June 13, 2018

Mulpleta (NME)
(Lusutrombopag; Shionogi)
Class/route: Thrombopoietin receptor agonist; oral tablets
Indication: For treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical procedure
Approval considerations: Fast track, priority review
Approval date: July 31, 2018

Nuzyra (NME)
(Omadacycline; Paratek Pharmaceuticals)
Class/route: Aminomethylcycline antibacterial within the tetracycline class; oral tablets and intravenous injection
Indications: For treatment of adults with community-acquired bacterial pneumonia caused by susceptible microorganisms, including Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae; and for treatment of adults with acute bacterial skin and skin structure infections caused by susceptible microorganisms, including S aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus group (includes S anginosus, S intermedius, and S constellatus), Enterococcus faecalis, Enterobacter cloacae, and K pneumoniae
Approval considerations: Fast track, priority review
Approval date: October 2, 2018

Olumiant (NME)
(Baricitinib; Eli Lilly)
Class/route: Janus kinase inhibitor; oral tablets
Indication: For treatment of adults with moderate-to-severe active rheumatoid arthritis who have had an inadequate response to treatment with ≥1 tumor necrosis factor antagonists
Limitations of use: The use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs, or potent immunosuppressants (eg, azathioprine, cyclosporine) is not recommended
Approval date: May 31, 2018

Omegaven (NME)
(Fish oil triglycerides; Fresenius Kabi USA)
Class/route: Omega-3 fatty acid; intravenous injectable emulsion
Indication: As a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis
Limitations of use: Fish oil triglycerides is not indicated to prevent parenteral nutrition-associated cholestasis
Approval considerations: Fast track, orphan drug, priority review
Approval date: July 27, 2018

Onpattro (NME)
(Patisiran; Alnylam Pharmaceuticals)
Class/route: First-in-class double-stranded small interfering RNA; lipid complex intravenous injection
Indication: For treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Approval considerations: Breakthrough therapy, fast track, orphan drug, priority review
Approval date: August 10, 2018

Orilissa (NME)
(Elagolix; AbbVie)
Class/route: First-in-class GnRH receptor antagonist; oral tablets
Indication: For management of moderate-to-severe pain associated with endometriosis
Approval considerations: Priority review
Approval date: July 23, 2018

Oxervate (BLA)
(Cenegermin-bkbj; Dompé)
Class/route: First-in-class recombinant human nerve growth factor; ophthalmic solution
Indication: For treatment of neurotrophic keratitis, a degenerative disease of the cornea
Approval considerations: Breakthrough therapy, fast track, orphan drug, priority review
Approval date: August 22, 2018

Palynziq (BLA)
(Pegvaliase-pqpz; BioMarin Pharmaceutical)
Class/route: First-in-class phenylalanine-metabolizing enzyme; subcutaneous injection
Indication: To reduce blood phenylalanine concentrations in adults with phenylketonuria (a genetic disease) and uncontrolled blood phenylalanine concentrations >600 mmol/L during current therapy
Approval considerations: Fast track, orphan drug, priority review, REMS program
Approval date: May 24, 2018

Pifeltro (NME)
(Doravirine; Merck)
Class/route: NNRTI; oral tablets
Indication: For treatment, in combination with other antiretroviral agents, of HIV-1 infection in adults who have not received previous antiretroviral therapy
Approval date: August 30, 2018

Poteligeo (NME)
(Mogamulizumab-kpkc; Kyowa Kirin)
Class/route: First-in-class CCR4-directed monoclonal antibody; intravenous injection
Indications: For treatment, after ≥1 previous systemic therapies, of adults with relapsed or refractory mycosis fungoides, or adults with Sézary syndrome; this is the first drug approved for Sézary syndrome
Approval considerations: Breakthrough therapy, orphan drug, priority review
Approval date: August 8, 2018

Revcovi (BLA)
(Elapegademase-lvlr; Leadiant Biosciences)
Class/route: Recombinant adenosine deaminase; intramuscular injection
Indication: For treatment of pediatric patients and adults with adenosine deaminase severe combined immune deficiency
Approval considerations: Fast track, orphan drug, priority review
Approval date: October 5, 2018

Seysara (NME)
(Sarecycline; Allergan)
Class/route: Tetracycline; oral tablets
Indication: For treatment of inflammatory lesions of nonnodular moderate-to-severe acne vulgaris in patients aged ≥9 years
Limitations of use: Efficacy beyond 12 weeks and safety beyond 12 months have not been established, nor has this drug been evaluated for treatment of infections; to reduce drug-resistant bacteria and to maintain the efficacy of other antibacterial drugs, this medication should only be used as indicated
Approval date: October 1, 2018

Symdeko (NME)
(Tezacaftor and ivacaftor; Vertex Pharmaceuticals)
Class/route: CFTR corrector and CFTR modulator; oral tablets
Indications: For treatment of patients with cystic fibrosis aged ≥12 years who are homozygous for the F508del mutation, or patients who have ≥1 CFTR genetic mutations that respond to therapy with tezacaftor plus ivacaftor, based on in vitro data and/or clinical evidence; if the patient’s genotype is unknown, an FDA-approved test for cystic fibrosis mutations is indicated to detect the presence of a CFTR mutation
Approval considerations: Breakthrough therapy, fast track, orphan drug, priority review
Approval date: February 13, 2018

Takhzyro (BLA)
(Lanadelumab-flyo; Dyax/Shire)
Class/route: Plasma kallikrein inhibitor; subcutaneous injection
Indication: Prophylaxis therapy to prevent attacks of hereditary angioedema in patients aged ≥12 years
Approval considerations: Breakthrough therapy, fast track, orphan drug, priority review
Approval date: August 23, 2018

Talzenna (NME)
(Talazoparib; Pfizer)
Class/route: PARP inhibitor; oral capsules
Indications: For treatment of adults with HER2-negative locally advanced or metastatic breast cancer and deleterious or suspected deleterious germline BRCA mutation, as detected by the BRACAnalysis CDx, an FDA-approved test
Approval considerations: Priority review
Approval date: October 16, 2018

Tavalisse (NME)
(Fostamatinib disodium hexahydrate; Rigel)
Class/route: First-in-class spleen tyrosine kinase inhibitor; oral tablets
Indication: For the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia who have had an insufficient response to previous treatment
Approval considerations: Orphan drug
Approval date: April 17, 2018

Tegsedi (NME)
(Inotersen; Akcea Therapeutics)
Class/route: First-in-class transthyretin-directed antisense oligonucleotide inhibitor; subcutaneous injection
Indication: For treatment of polyneuropathy associated with hereditary transthyretin-mediated amyloidosis in adults
Approval considerations: Fast track, orphan drug, priority review
Approval date: October 5, 2018

Tibsovo (NME)
(Ivosidenib; Agios Pharmaceuticals)
Class/route: First-in-class IDH1 inhibitor; oral tablets
Indication: For treatment of adults with relapsed or refractory AML and a susceptible IDH1 mutation, as detected by an FDA-approved test
Approval considerations: Fast track, orphan drug, priority review
Approval date: July 20, 2018

Tpoxx (NME)
(Tecovirimat/Catalent Pharma; SIGA Technologies)
Class/route: First-in-class orthopoxvirus-specific antiviral drug; oral capsules
Indication: For treatment of human smallpox disease caused by variola virus in adults and in pediatric patients weighing ≥13 kg; this is the first drug approved for the treatment of smallpox disease
Limitations of use: The efficacy of this drug for treatment of smallpox disease has not been determined in humans, because well-controlled clinical trials were not feasible; the drug’s efficacy may be reduced in immunocompromised patients
Approval considerations: Fast track, orphan drug, priority review
Approval date: July 13, 2018

Trogarzo (NME)
(Ibalizumab-uiyk; TaiMed Biologics)
Class/route: First-in-class CD4-directed post-attachment HIV-1 inhibitor; intravenous injection
Indication: For treatment, in combination with other antiretroviral(s), of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are not responding to current antiretroviral regimen
Approval considerations: Breakthrough therapy, fast track, orphan drug, priority review
Approval date: March 6, 2018

Ultomiris (BLA)
(Ravulizumab-cwvz; Alexion Pharmaceuticals)
Class/route: Complement inhibitor; intravenous injection
Indication: For treatment of adults with paroxysmal nocturnal hemoglobinuria
Approval considerations: Orphan drug, REMS program
Approval date: December 21, 2018

Vitrakvi (NME)
(Larotrectinib; Loxo Oncology)
Class/route: First-in-class tropomyosin receptor kinase inhibitor; oral capsules and oral solution
Indications: For treatment of pediatric patients and adults with solid tumors that are linked to an NTRK gene fusion and without a known acquired resistance mutation, are metastatic, or when surgical resection of the tumor is likely to result in severe morbidity, and the patient has no satisfactory alternative treatment or the tumor progressed after treatment; this is the second drug approved by the FDA based on a biologic marker rather than a tumor type
Approval considerations: Accelerated approval, break­through therapy, orphan drug, priority review
Approval date: November 26, 2018

Vizimpro (NME)
(Dacomitinib; Pfizer)
Class/route: Irreversible kinase EGFR inhibitor; oral tablets
Indication: For first-line treatment of patients with metastatic NSCLC and EGFR exon 19 deletion or exon 21 L858R substitution mutations, as detected by an FDA-approved test
Approval considerations: Orphan drug, priority review
Approval date: September 27, 2018

Xerava (NME)
(Eravacycline; Tetraphase Pharmaceuticals)
Class/route: Fluorocycline antibacterial in the tetracycline class; intravenous injection
Indications: For treatment of complicated intra-abdominal infections caused by susceptible microorganisms, including Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis, in patients aged ≥18 years
Limitations of use: Eravacycline is not indicated for treatment of complicated urinary tract infections
Approval considerations: Fast track, priority review
Approval date: August 27, 2018

Xofluza (NME)
(Baloxavir marboxil; Genentech)
Class/route: First-in-class polymerase acidic endonuclease inhibitor; oral tablets
Indication: For treatment of acute uncomplicated influenza in patients aged ≥12 years whose symptoms have lasted for ≤48 hours
Limitations of use: Influenza viruses change over time; change in their type or subtype, emerging resistance, or changes in viral virulence could diminish the benefit of antiviral drugs; verify drug susceptibility for influenza virus strains before using baloxavir marboxil
Approval considerations: Priority review
Approval date: October 24, 2018

Xospata (NME)
(Gilteritinib; Astellas Pharma)
Class/route: Multiple tyrosine kinases (including FLT3) inhibitor; oral tablets
Indication: For treatment of adults with relapsed or refractory AML and an FLT3 mutation, as detected by an FDA-approved test
Approval considerations: Fast track, orphan drug, priority review
Approval date: November 28, 2018

Yupelri (NME)
(Revefenacin; Mylan)
Class/route: Anticholinergic; oral inhalation solution
Indication: For maintenance treatment of patients with chronic obstructive pulmonary disease
Approval date: November 8, 2018

Zemdri (NME)
(Plazomicin; Achaogen)
Class/route: Aminoglycoside antibacterial; intravenous injection
Indication: For treatment of patients aged ≥18 years with complicated urinary tract infections, including pyelonephritis caused by the susceptible microorganism that include Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae; because only limited safety and efficacy data are available, reserve this drug for patients with no alternative options
Approval considerations: Priority review
Approval date: June 25, 2018

ALK indicates anaplastic lymphoma kinase; AML, acute myeloid leukemia; BLA, biologic license application; CCR4, CC chemokine receptor type 4; CFTR, cystic fibrosis transmembrane conductance regulator; FDA, US Food and Drug Administration; FLT3, FMS-like tyrosine kinase; GLA, amenable galactosidase alpha; GnRH, gonadotropin-releasing hormone; HER2, human epidermal growth factor receptor 2; IDH1, isocitrate dehydrogenase-1; IL, interleukin; ISTI, integrase strand transfer inhibitor; NETs, neuroendocrine tumors; NME, new molecular entity; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; NTRK, neurotrophic receptor tyrosine kinase; NSCLC, non–small-cell lung cancer; PARP, poly (ADP-ribose) polymerase; PD, programmed cell death; PI3K, phosphatidylinositol 3-kinase; REMS, Risk Evaluation and Mitigation Strategies; RNA, ribonucleic acid.

 

II. New Biosimilars Approved in 2018

Fulphila (new biosimilar)
(pegfilgrastim-jmdb; Mylan)
Class/route: Leukocyte growth factor (covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol); injection, for ­subcutaneous use
Reference drug: Neulasta (pegfilgrastim)
Approval considerations: First biosimilar to Neulasta
Indication: To reduce the risk for infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies who are receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia (it is not indicated for mobilization of peripheral blood progenitor cells for hematopoietic stem-cell transplantation)
Approval date: June 4, 2018

Herzuma (new biosimilar)
(trastuzumab-pkrb; Celltrion)
Class/route: Humanized IgG1 kappa monoclonal antibody; injection, for subcutaneous use
Reference drug: Herceptin (trastuzumab)
Approval considerations: Second biosimilar to Herceptin
Indications: First-line treatment of HER2 overexpressing metastatic breast cancer, in combination with paclitaxel; as monotherapy in HER2 overexpressing (as detected by an FDA-approved test) metastatic breast cancer after ≥1 chemotherapy regimens for metastatic disease; for adjuvant treatment of HER2 overexpressing node-positive or node-negative breast cancer, in combi­nation with doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, or in combination with docetaxel and carboplatin
Approval date: December 14, 2018

Hyrimoz (new biosimilar)
(adalimumab-adaz; Sandoz)
Class/route: Inhibitor of tumor necrosis factor; injection, for subcutaneous use
Reference drug: Humira (adalimumab)
Approval considerations: Third biosimilar to Humira
Indications: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis; reducing signs and symptoms of polyarticular juvenile idiopathic arthritis, in patients aged ≥4 years; reducing signs and symptoms, inhibiting progression, and improving physical function of adults with active psoria­tic arthritis; reducing signs and symptoms of active ankylosing spondylitis; reducing signs and symptoms and inducing and maintaining remission of moderately to severely active Crohn’s disease in patients who have had an inadequate response to conventional therapy, including infliximab, or are intolerant of infliximab; inducing or sustaining remission in moderately to severely active ulcerative colitis in adults who have had an inadequate response to immunosuppressant therapy; treatment of moderate-to-severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy, and when other systemic therapies are less appropriate
Approval date: October 31, 2018

Nivestym (new biosimilar)
(filgrastim-aafi; Pfizer)
Class/route: Leukocyte growth factor (recombinant human G-CSF); injection, for subcutaneous or intravenous use
Reference drug: Neupogen (filgrastim)
Approval considerations: Second biosimilar to Neupogen
Indications: To reduce infections, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies who are receiving myelosuppressive therapies; to reduce the time to neutrophil recovery and fever duration after chemotherapy in patients with AML; to reduce the duration of neutropenia and its sequelae, such as febrile neutropenia, in patients with AML after bone marrow transplantation; to enhance the process of leukapheresis; and for long-term use to reduce the incidence and duration of severe neutropenia in symptomatic patients
Approval date: July 20, 2018

Retacrit (new biosimilar)
(epoetin alfa-epbx; Hospira/Pfizer)
Class/route: Erythropoiesis-stimulating factor; injection, for intravenous or subcutaneous use
Reference drug: Epogen and Procrit (epoetin alfa)
Approval considerations: First biosimilar to Epogen and Procrit
Indications: Treatment of anemia caused by chronic kidney disease (in patients who are or are not undergoing dialysis); treatment of anemia caused by the use of zido­vudine in patients with HIV infection; treatment of anemia caused by the effects of concomitant myelosuppressive chemotherapy in patients who require at least 2 additional months of chemotherapy; and for the reduction of allogeneic red blood cell transfusions in patients undergoing elective noncardiac, nonvascular surgery
Approval date: May 15, 2018

Truxima (new biosimilar)
(rituximab-abbs; Celltrion)
Class/route: Chimeric murine/human monoclonal IgG1 kappa anti-CD20 antibody; injection, for intravenous use
Reference drug: Rituxan (rituximab)
Approval considerations: First biosimilar to Rituxan
Indications: Treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive B-cell
NHL as a single agent; for first-line treatment, in combination with chemotherapy, of patients with untreated follicular, CD20-positive B-cell NHL, and in patients achieving a complete or partial response to rituximab plus chemotherapy, as single-agent maintenance ­therapy; and for nonprogressing, low-grade, CD20-positive B-cell NHL, as a single agent after first-line treatment with cyclophosphamide, vincristine, and prednisone
Approval date: November 28, 2018

Udenyca (new biosimilar)
(pegfilgrastim-cbqv; Coherus)
Class/route: Leukocyte growth factor (covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol); injection, for ­subcutaneous use
Reference drug: Neulasta (pegfilgrastim)
Approval considerations: Second biosimilar to Neulasta
Indication: To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with ­nonmyeloid malignancies who are receiving myelo­suppressive anticancer drugs that are associated with a clinically significant incidence of febrile neutropenia
Approval date: November 2, 2018

AML indicates acute myeloid leukemia; FDA, US Food and Drug Administration; G-CSF, granulocyte ­colony-stimulating factor; NHL, non-Hodgkin lymphoma.

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Last modified: April 16, 2019
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