Difference between revisions of "Therapeutic equivalents"

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'''This page is very much under construction at the moment.'''
+
'''This page is very much under construction at the moment. It is possible that information here may be of assistance related to [[drug shortages]].'''
 
=Introduction=
 
=Introduction=
 
Generally speaking, prospective clinical trials are very specific in the drugs that they use in their evaluation. In clinical practice, one drug is often substituted for another, using the clinical concept of therapeutic equivalence. The purpose of this page is to gather various categories of therapeutic equivalence for general reference, and also to inform the [[Ontology|HemOnc ontology]]. Please keep checking back as the page develops!
 
Generally speaking, prospective clinical trials are very specific in the drugs that they use in their evaluation. In clinical practice, one drug is often substituted for another, using the clinical concept of therapeutic equivalence. The purpose of this page is to gather various categories of therapeutic equivalence for general reference, and also to inform the [[Ontology|HemOnc ontology]]. Please keep checking back as the page develops!
  
=Categories of therapeutically equivalent drugs=
+
=Categories of therapeutically similar drugs=
 
==Recombinant proteins==
 
==Recombinant proteins==
 
These are identical products to a parent natural protein, which are created through synthetic methods.
 
These are identical products to a parent natural protein, which are created through synthetic methods.
Line 12: Line 12:
 
|[[Asparaginase Erwinia chrysanthemi (Erwinaze)]]
 
|[[Asparaginase Erwinia chrysanthemi (Erwinaze)]]
 
|[[Asparaginase erwinia chrysanthemi-rywn (Rylaze)]]
 
|[[Asparaginase erwinia chrysanthemi-rywn (Rylaze)]]
 +
|-
 +
|[[Pegfilgrastim (Neulasta)]]
 +
|[[Lipefilgrastim (Lonquex)]]
 
|-
 
|-
 
|}
 
|}
  
 
==Biosimilars==
 
==Biosimilars==
These are "nearly identical" products to a parent compound, with what is considered interchangeable efficacy and toxicity.
+
These are "nearly identical" products to a parent compound, with what is considered interchangeable efficacy and toxicity. Note that EMA approvals do not include the four-letter suffix at this time, which we have added to distinguish the generic ingredient from the parent compound.
  
 
{| class="wikitable sortable" style="width: 75%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 75%; text-align:center;"  
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! style="width: 33%" |Parent compound
 
! style="width: 33%" |Parent compound
 
! style="width: 33%" |Biosimilar(s)
 
! style="width: 33%" |Biosimilar(s)
 +
|-
 +
|Anti-C5 antibody
 +
|[[Eculizumab (Soliris)]]
 +
|[[Eculizumab-beke (Bekemv)]]<br>[[Eculizumab-epys (Epysqli)]]
 
|-
 
|-
 
|Anti-VEGF antibody
 
|Anti-VEGF antibody
 
|[[Bevacizumab (Avastin)]]
 
|[[Bevacizumab (Avastin)]]
|[[Bevacizumab-adcd (Vegzelga)]]<br>[[Bevacizumab-awwb (Mvasi)]]<br>[[Bevacizumab-bvzr (Zirabev)]]<br>Bevacizumab (Alymsys/Oyavas)<br>Bevacizumab (Aybintio)<br>Bevacizumab (Equidacent)<br>Bevacizumab (Onbevzi)
+
|[[Bevacizumab-adcd (Vegzelga)]]<br>[[Bevacizumab-awwb (Mvasi)]]<br>[[Bevacizumab-aveg (Avegra)]]<br>[[Bevacizumab-aybi (Aybintio)]]<br>[[Bevacizumab-bvzr (Zirabev)]]<br>[[Bevacizumab-equi (Equidacent)]]<br>[[Bevacizumab-maly (Alymsys)]]<br>[[Bevacizumab-onbe (Onbevzi)]]<br>[[Bevacizumab-tnjn (Avzivi)]]
 +
|-
 +
|VEGF inhibitor
 +
|[[Ziv-aflibercept (Zaltrap)]]
 +
|[[Aflibercept-jbvf (Yesafili)]]<br>[[Aflibercept-yszy (Opuviz)]]
 
|-
 
|-
 
|Anticoagulant
 
|Anticoagulant
 
|[[Enoxaparin (Lovenox)]]
 
|[[Enoxaparin (Lovenox)]]
|Enoxaparin (Inhixa)
+
|[[Enoxaparin-inhi (Inhixa)]]
 
|-
 
|-
 
|Red cell growth factor
 
|Red cell growth factor
 
|[[Epoetin alfa (Procrit)]]
 
|[[Epoetin alfa (Procrit)]]
|[[Epoetin alfa-epbx (Retacrit)]]<br>Epoetin alfa (Abseamed)<br>Epoetin alfa (Binocrit)<br>Epoetin alfa (Epoetin Alfa Hexal)
+
|[[Epoetin alfa-epbx (Retacrit)]]<br>[[Epoetin alfa-abse (Abseamed)]]<br>[[Epoetin alfa-bino (Binocrit)]]<br>[[Epoetin alfa-hexa (Epoetin Alfa Hexal)]]
 
|-
 
|-
 
|Red cell growth factor
 
|Red cell growth factor
|Epoetin zeta (Eprex)
+
|[[Epoetin zeta (Eprex)]]
|Epoetin zeta (Silapo)
+
|[[Epoetin zeta-reta (Retacrit)]]<br>[[Epoetin zeta-sila (Silapo)]]
 
|-
 
|-
 
|Myeloid growth factor
 
|Myeloid growth factor
 
|[[Filgrastim (Neupogen)]]
 
|[[Filgrastim (Neupogen)]]
|[[Filgrastim-aafi (Nivestym)]]<br>[[Filgrastim-sndz (Zarxio)]]<br>Filgrastim (Accofil)<br>Filgrastim (Filgrastim Hexal)<br>Filgrastim (Grastofil)<br>Filgrastim (Ratiograstim)<br>Filgrastim (Tevagrastim)
+
|[[Filgrastim-aafi (Nivestym)]]<br>[[Filgrastim-sndz (Zarxio)]]<br>[[Filgrastim-acco (Accofil)]]<br>[[Filgrastim-ayow (Releuko)]]<br>[[Filgrastim-hexa (Filgrastim Hexal)]]<br>[[Filgrastim-gras (Grastofil)]]<br>[[Filgrastim-rati (Ratiograstim)]]<br>[[Filgrastim-teva (Tevagrastim)]]
 
|-
 
|-
 
|Myeloid growth factor
 
|Myeloid growth factor
 
|[[Pegfilgrastim (Neulasta)]]
 
|[[Pegfilgrastim (Neulasta)]]
|[[Pegfilgrastim-apgf (Nyvepria)]]<br>[[Pegfilgrastim-bmez (Ziextenzo)]]<br>[[Pegfilgrastim-cbqv (Udenyca)]]<br>[[Pegfilgrastim-jmdb (Fulphila)]]<br>Pegfilgrastim (Cegfila)<br>Pegfilgrastim (Grasustek)<br>Pegfilgrastim (Pelgraz)<br>Pegfilgrastim (Pelmeg)
+
|[[Pegfilgrastim-apgf (Nyvepria)]]<br>[[Pegfilgrastim-bmez (Ziextenzo)]]<br>[[Pegfilgrastim-cbqv (Udenyca)]]<br>[[Pegfilgrastim-jmdb (Fulphila)]]<br>[[Pegfilgrastim-cegf (Cegfila)]]<br>[[Pegfilgrastim-fpgk (Stimufend)]]<br>[[Pegfilgrastim-gras (Grasustek)]]<br>[[Pegfilgrastim-pbbk (Fylnetra)]]<br>[[Pegfilgrastim-pelg (Pelgraz)]]<br>[[Pegfilgrastim-pelm (Pelmeg)]]<br>[[Pegfilgrastim-stim (Stimufend)]]
 
|-
 
|-
 
|Anti-CD20 antibody
 
|Anti-CD20 antibody
 
|[[Rituximab (Rituxan)]]
 
|[[Rituximab (Rituxan)]]
|[[Rituximab-abbs (Truxima)]]<br>[[Rituximab-arrx (Riabni)]]<br>[[Rituximab-pvvr (Ruxience)]]<br>Rituximab (Blitzima)<br>Rituximab (Ritemvia)<br>Rituximab (Rixathon)<br>Rituximab (Riximyo)
+
|[[Rituximab-abbs (Truxima)]]<br>[[Rituximab-arrx (Riabni)]]<br>[[Rituximab-pvvr (Ruxience)]]<br>[[Rituximab-blit (Blitzima)]]<br>[[Rituximab-rite (Ritemvia)]]<br>[[Rituximab-rixa (Rixathon)]]<br>[[Rituximab-rixi (Riximyo)]]
 
|-
 
|-
 
|Anti-HER2 antibody
 
|Anti-HER2 antibody
 
|[[Trastuzumab (Herceptin)]]
 
|[[Trastuzumab (Herceptin)]]
|[[Trastuzumab-anns (Kanjinti)]]<br>[[Trastuzumab-dkst (Ogivri)]]<br>[[Trastuzumab-dttb (Ontruzant)]]<br>[[Trastuzumab-pkrb (Herzuma)]]<br>[[Trastuzumab-qyyp (Trazimera)]]<br>Trastuzumab (Zercepac)
+
|[[Trastuzumab-anns (Kanjinti)]]<br>[[Trastuzumab-dkst (Ogivri)]]<br>[[Trastuzumab-dttb (Ontruzant)]]<br>[[Trastuzumab-herw (Herwenda)]]<br>[[Trastuzumab-pkrb (Herzuma)]]<br>[[Trastuzumab-qyyp (Trazimera)]]<br>[[Trastuzumab-strf (Hercessi)]]<br>[[Trastuzumab-zerc (Zercepac)]]
 
|-
 
|-
 
|}
 
|}
  
 
==Same drug, different route==
 
==Same drug, different route==
These agents generally are first approved as IV formulations, and then are approved as SC with an additional vehicle. Efficacy is considered to be equivalent, but toxicity may differ.
+
These agents generally are first approved as IV formulations, and then are approved for a more convenient route, usually with a different vehicle. Efficacy is considered to be equivalent, but toxicity may differ.
 
{| class="wikitable sortable" style="width: 75%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 75%; text-align:center;"  
 
! style="width: 33%" |Class of agent
 
! style="width: 33%" |Class of agent
! style="width: 33%" |IV formulation
+
! style="width: 33%" |Original formulation
! style="width: 33%" |SC formulation
+
! style="width: 33%" |Alternative formulation
 
|-
 
|-
 
|Anti-CD38 antibody
 
|Anti-CD38 antibody
 
|[[Daratumumab (Darzalex)]]
 
|[[Daratumumab (Darzalex)]]
 
|[[Daratumumab and hyaluronidase (Darzalex Faspro)]]
 
|[[Daratumumab and hyaluronidase (Darzalex Faspro)]]
 +
|-
 +
|Hypomethylating agent
 +
|[[Azacitidine (Vidaza)]]
 +
|[[Azacitidine oral (Onureg)]]
 +
|-
 +
|Hypomethylating agent
 +
|[[Decitabine (Dacogen)]]
 +
|[[Decitabine and cedazuridine (Inqovi)]]
 
|-
 
|-
 
|Anti-CD20 antibody
 
|Anti-CD20 antibody
Line 77: Line 96:
 
|-
 
|-
 
|}
 
|}
 +
 
==Combinations of agents==
 
==Combinations of agents==
 
(e.g., Phesgo is combined pertuzumab & trastuzumab)
 
(e.g., Phesgo is combined pertuzumab & trastuzumab)
 +
 +
==Depot formulations==
  
 
==Enantiomers and racemic mixtures==
 
==Enantiomers and racemic mixtures==
 +
 +
==Same drug, different dose/frequency==
  
 
==Pro-drugs==
 
==Pro-drugs==
Line 86: Line 110:
  
 
==Same class==
 
==Same class==
(e.g., cisplatin and carboplatin)
+
(e.g., possibly cisplatin and carboplatin; definitely prednisone and prednisolone)
  
 
[[Category:Stub]]
 
[[Category:Stub]]
Line 92: Line 116:
 
[[Category:General reference pages]]
 
[[Category:General reference pages]]
 
[[Category:Ontology pages]]
 
[[Category:Ontology pages]]
 +
 +
=References=
 +
#Nahleh Z, Lyman GH, Schilsky RL, Peterson DE, Tagawa ST, Chavez-MacGregor M, Rumble RB, Gupta S. Use of Biosimilar Medications in Oncology. JCO Oncol Pract. 2022 Mar;18(3):177-186. Epub 2022 Jan 18. [https://doi.org/10.1200/op.21.00771 link to original article] [https://pubmed.ncbi.nlm.nih.gov/35041524/ PubMed]
 +
#Rodriguez G, Mancuso J, Lyman GH, Cardoso F, Nahleh Z, Vose JM, Gralow JR, Francisco M, Sherwood S. ASCO Policy Statement on Biosimilar and Interchangeable Products in Oncology. JCO Oncol Pract. 2023 Jul;19(7):411-419. Epub 2023 Apr 7. [https://doi.org/10.1200/op.22.00783 link to original article] [https://pubmed.ncbi.nlm.nih.gov/37027797/ PubMed]

Latest revision as of 15:43, 25 May 2024

This page is very much under construction at the moment. It is possible that information here may be of assistance related to drug shortages.

Introduction

Generally speaking, prospective clinical trials are very specific in the drugs that they use in their evaluation. In clinical practice, one drug is often substituted for another, using the clinical concept of therapeutic equivalence. The purpose of this page is to gather various categories of therapeutic equivalence for general reference, and also to inform the HemOnc ontology. Please keep checking back as the page develops!

Categories of therapeutically similar drugs

Recombinant proteins

These are identical products to a parent natural protein, which are created through synthetic methods.

Parent compound Recombinant protein
Asparaginase Erwinia chrysanthemi (Erwinaze) Asparaginase erwinia chrysanthemi-rywn (Rylaze)
Pegfilgrastim (Neulasta) Lipefilgrastim (Lonquex)

Biosimilars

These are "nearly identical" products to a parent compound, with what is considered interchangeable efficacy and toxicity. Note that EMA approvals do not include the four-letter suffix at this time, which we have added to distinguish the generic ingredient from the parent compound.

Class of agent Parent compound Biosimilar(s)
Anti-C5 antibody Eculizumab (Soliris) Eculizumab-beke (Bekemv)
Eculizumab-epys (Epysqli)
Anti-VEGF antibody Bevacizumab (Avastin) Bevacizumab-adcd (Vegzelga)
Bevacizumab-awwb (Mvasi)
Bevacizumab-aveg (Avegra)
Bevacizumab-aybi (Aybintio)
Bevacizumab-bvzr (Zirabev)
Bevacizumab-equi (Equidacent)
Bevacizumab-maly (Alymsys)
Bevacizumab-onbe (Onbevzi)
Bevacizumab-tnjn (Avzivi)
VEGF inhibitor Ziv-aflibercept (Zaltrap) Aflibercept-jbvf (Yesafili)
Aflibercept-yszy (Opuviz)
Anticoagulant Enoxaparin (Lovenox) Enoxaparin-inhi (Inhixa)
Red cell growth factor Epoetin alfa (Procrit) Epoetin alfa-epbx (Retacrit)
Epoetin alfa-abse (Abseamed)
Epoetin alfa-bino (Binocrit)
Epoetin alfa-hexa (Epoetin Alfa Hexal)
Red cell growth factor Epoetin zeta (Eprex) Epoetin zeta-reta (Retacrit)
Epoetin zeta-sila (Silapo)
Myeloid growth factor Filgrastim (Neupogen) Filgrastim-aafi (Nivestym)
Filgrastim-sndz (Zarxio)
Filgrastim-acco (Accofil)
Filgrastim-ayow (Releuko)
Filgrastim-hexa (Filgrastim Hexal)
Filgrastim-gras (Grastofil)
Filgrastim-rati (Ratiograstim)
Filgrastim-teva (Tevagrastim)
Myeloid growth factor Pegfilgrastim (Neulasta) Pegfilgrastim-apgf (Nyvepria)
Pegfilgrastim-bmez (Ziextenzo)
Pegfilgrastim-cbqv (Udenyca)
Pegfilgrastim-jmdb (Fulphila)
Pegfilgrastim-cegf (Cegfila)
Pegfilgrastim-fpgk (Stimufend)
Pegfilgrastim-gras (Grasustek)
Pegfilgrastim-pbbk (Fylnetra)
Pegfilgrastim-pelg (Pelgraz)
Pegfilgrastim-pelm (Pelmeg)
Pegfilgrastim-stim (Stimufend)
Anti-CD20 antibody Rituximab (Rituxan) Rituximab-abbs (Truxima)
Rituximab-arrx (Riabni)
Rituximab-pvvr (Ruxience)
Rituximab-blit (Blitzima)
Rituximab-rite (Ritemvia)
Rituximab-rixa (Rixathon)
Rituximab-rixi (Riximyo)
Anti-HER2 antibody Trastuzumab (Herceptin) Trastuzumab-anns (Kanjinti)
Trastuzumab-dkst (Ogivri)
Trastuzumab-dttb (Ontruzant)
Trastuzumab-herw (Herwenda)
Trastuzumab-pkrb (Herzuma)
Trastuzumab-qyyp (Trazimera)
Trastuzumab-strf (Hercessi)
Trastuzumab-zerc (Zercepac)

Same drug, different route

These agents generally are first approved as IV formulations, and then are approved for a more convenient route, usually with a different vehicle. Efficacy is considered to be equivalent, but toxicity may differ.

Class of agent Original formulation Alternative formulation
Anti-CD38 antibody Daratumumab (Darzalex) Daratumumab and hyaluronidase (Darzalex Faspro)
Hypomethylating agent Azacitidine (Vidaza) Azacitidine oral (Onureg)
Hypomethylating agent Decitabine (Dacogen) Decitabine and cedazuridine (Inqovi)
Anti-CD20 antibody Rituximab (Rituxan) Rituximab and hyaluronidase human (Rituximab Hycela)
Anti-HER antibody Trastuzumab (Herceptin) Trastuzumab and hyaluronidase (Herceptin Hylecta)

Combinations of agents

(e.g., Phesgo is combined pertuzumab & trastuzumab)

Depot formulations

Enantiomers and racemic mixtures

Same drug, different dose/frequency

Pro-drugs

(e.g., capecitabine & 5-FU, although this is tricky because of LCV...)

Same class

(e.g., possibly cisplatin and carboplatin; definitely prednisone and prednisolone)

References

  1. Nahleh Z, Lyman GH, Schilsky RL, Peterson DE, Tagawa ST, Chavez-MacGregor M, Rumble RB, Gupta S. Use of Biosimilar Medications in Oncology. JCO Oncol Pract. 2022 Mar;18(3):177-186. Epub 2022 Jan 18. link to original article PubMed
  2. Rodriguez G, Mancuso J, Lyman GH, Cardoso F, Nahleh Z, Vose JM, Gralow JR, Francisco M, Sherwood S. ASCO Policy Statement on Biosimilar and Interchangeable Products in Oncology. JCO Oncol Pract. 2023 Jul;19(7):411-419. Epub 2023 Apr 7. link to original article PubMed