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. 2017 Dec;23(12):10.18553/jmcp.2017.23.12.1234. doi: 10.18553/jmcp.2017.23.12.1234

TABLE 2.

Indications, Dosage Formulations, Extrapolation, and Advisory Committee Vote for Biosimilars11-13,15,16,37-45

Biosimilar (Approval Date; Date on Market) and Its Reference Product (Approval Date)a Indications Formulations Extrapolation Advisory Committee Vote (Favor: Against Licensure)
Biosimilar Reference Product
Zarxio [filgrastim-sndz] (3/6/15; 9/3/15)
Neupogen [filgrastim] (2/20/91)

  1. Decrease incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer agents associated with a significant incidence of severe neutropenia with fever

  2. Reduce time to neutrophil recovery and duration of fever following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia

  3. Reduce duration of neutropenia and neutropenia-related clinical sequelae (e.g., febrile neutropenia) in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy following bone marrow transplantation

  4. Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis

  5. Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia


Reference product indication for which biosimilar was not approved by FDA:

  1. Increase survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome)

 Injection: 300 mcg/0.5 mL in a single-dose prefilled syringe with BD UltraSafe Passive Needle Guard Injection: 300 mcg/0.5 mL in a singledose prefilled syringe with an UltraSafe Needle Guard Clinical study done in breast cancer patients undergoing 6 cycles of TAC.
Extrapolated to 4/6 other indications due to demonstration of:

  • MOA: 4/5 approved indications relate to level of neutrophils in peripheral blood. 1/5 approved indications relates to level of CD34+ stem cells in peripheral blood. Binding of filgrastim to granulocyte colony-stimulating factor receptor on cells is the first step of filgrastim-mediated neutrophil differentiation and proliferation, as well as in CD34+ stem cell mobilization. Analytical and functional characteristics related to the MOA were similar between filgrastim-sndz and filgrastim.

  • Biosimilarity (analytical, PK, immunogenicity, safety profiles) to filgrastim.

 14:0
Injection: 480 mcg/0.5 mL in a single-dose prefilled syringe with BD UltraSafe Passive Needle Guard Injection: 480 mcg/0.5 mL in a singledose prefilled syringe with an UltraSafe Needle Guard
Injection: 300 mcg/0.5 mL in a singledose vial
Injection: 480 mcg/0.5 mL in a singledose vial
Inflectra [infliximab-dyyb] (4/5/16; 10/17/16)
Remicade [infliximab] (08/24/98)

  1. CD (adult and pediatric patients aged 6 or older)

  2. UC in adults

  3. RA

  4. AS

  5. PsA

  6. PsO in adults


Reference product indication for which biosimilar was not approved by FDA:

  1. Pediatric UC

 100 mg of lyophilized infliximab-dyyb in a 20 mL vial for intravenous infusion 100 mg of lyophilized infliximab in a 20 mL vial for intravenous infusion Clinical studies done in RA and AS.
Extrapolated to 4/7 other indications due to demonstration of:

  • MOA of infliximab-dyyb (binding and neutralization of soluble and membrane TNF-α, which is similar to infliximab).

  • Biosimilarity (analytical, PK, immunogenicity, safety profiles) to infliximab.

 21:3
Erelzi [etanercept-szzs] (8/30/16; expected earliest 2018)
Enbrel [etanercept] (11/02/98)

  1. RA

  2. JIA in patients 2 years or older

  3. PsA

  4. AS

  5. PsO in patients 18 years or older


Reference product indication for which biosimilar was not approved by FDA:

  1. PsO in patients between 4 and 17 years

 Injection: 25 mg/0.5 mL in a single-dose prefilled syringe with BD UltraSafe Passive Needle Guard Injection: 25 mg/0.5 mL in a singledose prefilled syringe Clinical studies done in PsO.
Extrapolated to 4/6 other indications due to demonstration of:

  • MOA (etanercept-szzs and etanercept’s MOA are TNF-α binding and neutralization).

  • Biosimilarity (analytical, PK, immunogenicity, safety profiles) to etanercept.

 20:0
Injection: 50 mg/mL in a single-dose prefilled syringe with BD UltraSafe Passive Needle Guard Injection: 50 mg/mL in a single-dose prefilled syringe
Injection: 50 mg/mL solution in singledose prefilled Sensoready Pen Injection: 50 mg/mL solution in single-dose prefilled SureClick Autoinjector
Injection: 25 mg lyophilized powder in a multiple-dose vial for reconstitution
Amjevita [adalimumab-atto] (9/23/16; expected earliest 2018)
Humira [adalimumab] (12/31/02)

  1. RA in adults

  2. JIA in patients 4 years or older

  3. PsA in adults

  4. CD in adults

  5. UC in adults

  6. PsO in adults

  7. AS in adults


Reference product indication for which biosimilar was not approved by FDA:

  1. Pediatric CD

  2. Hidradenitis suppurativa

  3. Uveitis

  4. JIA in patients 2 to <4 years

 Injection: 40 mg/0.8 mL in a single-use prefilled SureClick autoinjector Injection: 40 mg/0.8 mL in a single-use prefilled pen Clinical studies done in RA and PsO.
Extrapolated to 5/11 other indications due to demonstration of:

  • Similar MOA for adalimumab-atto and adalimumab. Specifically, the primary MOA for RA, JIA, AS, PsA, and PsO, and likely MOA in CD and UC is inhibition of binding of sTNF to cell-surface receptors and through binding tmTNF, inhibiting subsequent signal transduction and adhesion molecule expression. There are additional likely and plausible MOA in CD and UC. Biosimilar was similar to reference product structurally and functionally related to all above MOA.

  • Biosimilarity (analytical, PK, immunogenicity, safety profiles) to reference product.

 26:0
Injection: 40 mg/0.4 mL in a single-use prefilled pen
Injection: 40 mg/0.8 mL in a single-use prefilled glass syringe Injection: 40 mg/0.8 mL in a single-use prefilled glass syringe
Injection: 40 mg/0.4 mL in a single-use prefilled glass syringe
Injection: 20 mg/0.4 mL in a single-use prefilled glass syringe Injection: 20 mg/0.4 mL in a single-use prefilled glass syringe
Injection: 10 mg/0.2 mL in a single-use prefilled glass syringe
Injection: 40 mg/0.8 mL in a single-use glass vial for institutional use only
Renflexis [infliximab-abda] (04/21/17; 07/25/17)
Remicade [infliximab] (08/24/98)

  1. CD (adult and pediatric patients aged 6 or older)

  2. UC in adults

  3. RA

  4. A

  5. PsA

  6. PsO in adults


Reference product indication for which biosimilar was not approved by FDA:

  1. Pediatric UC

 100 mg of lyophilized infliximab-abda in a 20 mL vial for intravenous infusion 100 mg of lyophilized infliximab in a 20 mL vial for intravenous infusion N/A N/A

aReference product is shown in italics.

AS = ankylosing spondylitis; CD = Crohn’s disease; CD34+ = hematopoietic progenitor cell antigen; FDA = U.S. Food and Drug Administration; JIA = juvenile idiopathic arthritis; MOA = mechanism of action; N/A = not available; PK = pharmacokinetic, PsO = plaque psoriasis; PsA = psoriatic arthritis; RA = rheumatoid arthritis; TAC = docetaxel, doxorubicin, and cyclophosphamide; TNF-α = tumor necrosis factor-α; sTNF = soluble TNF-α; tmTNF = transmembrane TNF-α; UC = ulcerative colitis.