Therapeutic equivalence


Therapeutic equivalent” means that the product is approved by the FDA [new drug application (NDA) or abbreviated new drug application (ANDA)], it is pharmaceutically equivalent, and it is bioequivalent to the brand name product.

Therapeutic equivalence evaluations are a scientific judgment based upon evidence, while generic substitution may involve social and economic policy administered by the states, e.g., reducing the cost of drugs to consumers.Jan 19, 2022


What does “therapeutic equivalent” mean?

“Therapeutic equivalent” means that the product is approved by the FDA [new drug application (NDA) or abbreviated new drug application (ANDA)], it is pharmaceutically equivalent, and it is bioequivalent to the brand name product.

What are the TE codes for therapeutic equivalence?

Sample TE codes: AA, AB, BC (More on TE Codes) FDA assigns therapeutic equivalence codes to pharmaceutically equivalent drug products. A drug product is deemed to be therapeutically equivalent (” A ” rated) only if:

What are pharmaceutical equivalents?

Pharmaceutical Equivalents :FDA considers drug products to be pharmaceutical equivalents if they meet these three criteria: 1. they contain the same active ingredient(s) 2. they are of the same dosage form and route of administration 3. they are identical in strength or concentration

Can the therapeutic equivalence of two bioinequivalent formulations be assumed?

15 Although therapeutic equivalence is assured if two formulations are bioequivalent, the therapeutic equivalence of two bioinequivalent formulations can be judged only within a specific clinical context. William Irwin, in Information Resources in Toxicology (Fifth Edition), 2020


What is therapeutic equivalence of generic drugs?

Generic Drug The FDA bases evaluations of substitutability, or “therapeutic equivalence,” of generic drugs on scientific evaluations. By law, a generic drug product must contain the identical amounts of the same active ingredient(s) as the brand name product.

What is the difference between pharmaceutical equivalence and therapeutic equivalence?

A drug that is therapeutically equivalent must be both pharmaceutically equivalent and bioequivalent: A pharmaceutical equivalent drug is one where the active ingredient, dosage, concentration/strength, and route of delivery are the same as the brand drug.

Why is therapeutic equivalence important?

It allows users to determine quickly whether the Agency has evaluated a particular approved product as therapeutically equivalent to other pharmaceutically equivalent products and provides additional information on the basis of the FDA’s evaluations.

What is the difference between pharmaceutical and therapeutic?

pharmacological effects belong to drugs effect on body and therapetic effects is how drug work positively. pharmacologiacal effect means both study of pharmacokinetics and pharmacodynamics of the drug.

What is the meaning of therapeutic equivalence quizlet?

– Therapeutic equivalence occurs when two drugs are bioequivalent, have the same active ingredient, and have the same strength, dosage form, and route of administration. – A brand name drug and its generic counterpart with the same dosage form, strength, and route of administration are therapeutic equivalents.

What does therapeutically equivalent mean?

Approved drug products are considered to be therapeutic equivalents if they are pharmaceutical equivalents for which bioequivalence has been demonstrated, and they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.

What are the benefits of a therapeutic interchange?

Therapeutic interchange programs enable pharmacy managers to neutralize or at least slow the rate of drug cost increases, ensuring appropriate utilization of resources and more favorable patient outcomes.

What is the difference between generic substitution and therapeutic substitution?

In generic substitution, a generic drug is substituted for a brand name drug. However, both drugs have the same active chemical ingredient, same dosage strength, and same dosage form. Therapeutic substitution occurs when a pharmacist substitutes a chemically different drug for the drug that the physician prescribed.

What is pharmaceutical substitution?

Therapeutic substitution occurs when a pharmacist substitutes a chemically different drug for the drug that the physician prescribed. The drug substituted by the pharmacist belongs to the same pharmacologic class and/or to the same therapeutic class.

What is a therapeutic interchange?

Therapeutic interchange is the practice of replacing, with the prescribing practitioner’s approval, a prescription medication originally prescribed for a patient with an alternative prescription medication.

What is chemical equivalence in pharmacology?

Chemical equivalence indicates that drug products contain the same active compound in the same amount and meet current official standards; however, inactive ingredients in drug products may differ.

What is pharmaceutical equivalence Mcq?

Explanation: Pharmaceutic equivalence implies that two or more drug products when they are identical in strength, purity, content uniformity, and disintegration and dissolution characteristics. Though the excipients may differ.

Additional Resources

The Orange Book downloadable data files are updated monthly.

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The Orange Book downloadable data files are updated monthly.

What is generic substitution?

Commonly known as “generic substitution,” every state has evolved a process to overcome the “antisubstitution” laws that proliferated during the late 1940s. Antisubstitution may still be in place, but beginning in the early 1970s, every state enacted legislation for providing equivalent lower cost medication. States are highly variable in the precise details, but this often involves reference to FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (aka Orange Book). “Therapeutic equivalent” means that the product is approved by the FDA [new drug application (NDA) or abbreviated new drug application (ANDA)], it is pharmaceutically equivalent, and it is bioequivalent to the brand name product. However, it is important to note that the Orange Book is only a reference guide, FDA does not dictate the process for generic substitution; this is left to the individual states.

What is a phase 3 biosimilar?

Phase III clinical trials comparing biosimilars with their respective reference originators are clinical studies designed to assess therapeutic equivalence, at variance with conventional randomized controlled trials that are designed to demonstrate superiority of one treatment compared to another. In the setting of biosimilar development, the appropriate design of therapeutic equivalence studies is faced with a number of methodological challenges. When implementing an equivalence study, the classical rigorous ‘intention-to-treat’ approach – relying on the concept that more patients leaving an intervention arm due to the occurrence of adverse events would represent a bias in favor of the other treatment, if the analyses were limited only to the patients that completed the protocol – would on the contrary bias toward the conclusion that the biosimilar is equivalent. For this reason, it is recommended that equivalence studies for biosimilars should perform ‘per protocol’ analyses and present their data with 95% confidence intervals for a difference, rather than with a single p value. In particular, equivalence could be declared, according to the generally accepted standard, if the confidence intervals of the comparator compound (the biosimilar product) lie within ±15% of those estimated for the reference compound (the originator product) [47].

Is epilepsy a chronic disease?

Epilepsy being a chronic disease requires years long duration of treatment and in many cases life-long management at outpatient basis. Hence, it stands as a strong candidate for pharmacists to contribute especially in community settings including:

Do TE studies need CE?

TE studies with CE are currently required by the US FDA and HC for a generic submission of OIPs. Based on the step-wise approach, the EU would require such studies only when the in vitro and/or PK studies do not show equivalence. A vital element of a TE study with CE is the demonstration of a dose–response relationship, in order to confirm that a lack of difference in the CE is truly because the test and reference generate a similar level of effect, and not because the study lacks sensitivity in detecting a difference. This has been a major challenge, especially for products such as ICS, and is discussed further below.

What is therapeutic equivalent?

therapeutic equivalent. A drug that has the same pharmacological effects and actions in the treatment of illnesses as another drug even though the drugs may not be chemically equivalent. See also: equivalent. Medical Dictionary, © 2009 Farlex and Partners.

What is USP in medicine?

The company said the US Food and Drug Administration (USFDA) approved Atomoxetine Capsules, USP, is the therapeutic equivalent generic version of Strattera (atomoxetine) Capsules.

Is PFNX a teriparatide?

Pfenex (PFNX) and Alvogen announced entering into an agreement granting Alvogen exclusive rights to commercialize Pfenex’s lead drug candidate, PF708, a teriparatide therapeutic equivalent candidate to Eli Lilly’s (LLY) Forteo, in the United States. Pfenex announces commercialization agreement for PF708 with Alvogen.

How to identify therapeutic equivalents?

Becoming more familiar with a drug’s brand and generic names will help you identify therapeutic equivalents. Also, pay attention to the endings of generic drug names. They can help you determine which drugs are in the same drug class and may be interchangeable. But remember, only a pharmacist can make these recommendations to the physician or patient.

What is bio equivalent?

Bioequivalent, safe & easily absorbed into the body, have the same identical amounts of the active ingredient, the substance is what it is designed to do. Must have same strengths, dosage form & route of administration. Must meet standards of quality and purity.

What is generic name?

A generic name is the name given by the:

When do two drugs have the same clinical effect?

According to FDA, when 2 drugs have the same clinical effect, but different manufacturers. Drugs must be safe and effective and they must be deemed as pharmaceutically equivalent. Dosage form and route must be the same.

Do therapeutic equivalents need to be the same?

Therapeutic equivalent drugs do not need to have the same:

Can you substitute esomeprazole for pantoprazole?

These drugs aren’t the same active ingredient, however, they are in the same class or “family” of drugs. They both are effective in the treatment of acid reflux and work using similar methods. It’s possible that the pharmacist will interchange, or substitute, the pantoprazole for esomeprazole. Of course, these substitutions can only be made by the pharmacist and only with the prescribing physician ‘s permission.

What is an abbreviated drug application?

Generic drug applications are called “abbreviated” because they are generally not required to include preclinical (animal) …

How many digits are in a drug application?

New Drug Application (NDA) Number. This six digit number is assigned by FDA staff to each application for approval to market a new drug in the United States. A drug can have more than one application number if it has different dosage forms or routes of administration.

What is FDA approved label?

Label. The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it ; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient.

What is a drug?

In general, the term “drugs” includes therapeutic biological products.

When does the FDA issue a tentative approval letter?

If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed drug product, FDA issues a tentative approval letter to the applicant. The tentative approval letter details the circumstances associated with the tentative approval.

Can a drug have more than one application number?

One drug can have more than one application number if it has different dosage forms or routes of administration. Generic Drug. A generic drug is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use.

Can a company change the label of a drug?

Supplement Type. Companies are allowed to make changes to drugs or their labels after they have been approved. To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA).


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