Difference between revisions of "Therapeutic equivalents"
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Revision as of 12:09, 4 September 2023
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) |
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.
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
- 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
- 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