Will Purple Become the New orange? the New FDA Purple Book for Biologics: What Does the Future hold?

Sabatelli, Anthony D; Alpha-Cobb, Cambria J

doi:10.4155/ppa.14.58

Cited by 4 publications

(5 citation statements)

References 2 publications

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Section: Resultsmentioning

confidence: 99%

“…50 Furthermore, the purple book was recently released by the FDA listing innovator biological products and biosimilars and the approved interchangeable drugs under the public health service act. 51 Interchangeability Doctors can substitute a brand drug to its corresponding generic or biosimilar drug. Nevertheless, inter-substitutions between generics or biosimilars is not recommended.…”

Section: Regulationsmentioning

confidence: 99%

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Assessment of the differences between generic and biosimilar drugs: A brief literature review

Sayah

Awada

Ismaiil

et al. 2023

Journal of Generic Medicines

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Generic Drugs are copies of small chemical drugs identical to their reference drug by dose, form, safety, strength, mode of administration, quality, performance, and intended purpose. They have been on the market for a long time and have abbreviated pathways to be approved. Their development is more simple and more affordable than their reference counterpart, which makes them widely used by patients. More recently, biosimilars were introduced to the market with strict regulations. They are highly similar to large, complex molecules, known as biological drugs, in terms of quality characteristics, biological activity, safety, and efficacy. Their development is complex and expensive, where clinical trials are necessary. Even though generic drugs and biosimilars are both copies of a reference drug, they differ in many aspects. Misconceptions or misinformation among healthcare stakeholders could have limited their use. Therefore, this short review aims to compare generic drugs and biosimilars in terms of characteristics, development, regulation, and interchangeability with brand drugs. Findings from this report can help clarify misconceptions and promote their use.

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Section: Resultsmentioning

confidence: 99%

Section: Regulationsmentioning

confidence: 99%

Assessment of the differences between generic and biosimilar drugs: A brief literature review

Sayah

Awada

Ismaiil

et al. 2023

Journal of Generic Medicines

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“…Small synthetically manufactured molecules make up the vast majority of drugs on the market (Sabatelli and Alpha-Cobb, 2015). These drugs are typically low in molecular weight and structural complexity, as the four molecules described in this paper.…”

Section: Drugmentioning

confidence: 98%

“…Because biologics are manufactured using living cells, they often require costly and sophisticated purification, isolation, and handling techniques (Sabatelli and Alpha-Cobb, 2015). Some industry experts want to exclude biologics from abuse liability screening altogether based on molecular size and/or the premise that the biologic has no interaction at relevant concentrations with molecular targets considered relevant for dependence potential, or that when biologics bind to relevant targets the binding does not result in relevant functional effects when administered consistent with medically prescribed doses or targeted therapeutic plasma concentrations.…”

Section: Drugmentioning

confidence: 99%

Preclinical assessment of abuse liability of biologics: In defense of current regulatory control policies

Gauvin

Zimmermann

Baird

2015

Regulatory Toxicology and Pharmacology

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“…As an available resource, the FDA maintains two sets of listings of approved products. These include the Orange Book: Approved Drug Products with Therapeutic equivalence evaluations (16) and the Purple Book: Lists of Licensed Biological Products (17), which discusses product exclusivity and biosimilarity evaluations. A request for orphan drug designation (ODD), designed for drugs and biologics used to treat rare diseases or conditions (defined as one that affects fewer than 200,000 people per year in the U.S., or more than 200,000 if there is no expectation of recovery of development costs) might also be considered (e-CFR 21 PART 316 Orphan Drug & the Orphan Drug Act 1983).…”

Section: Session I: Roles Of Us Government Agencies Involved In Repmentioning

confidence: 99%

Challenges and Benefits of Repurposing Products for Use during a Radiation Public Health Emergency: Lessons Learned from Biological Threats and other Disease Treatments

DiCarlo

Cassatt

Dowling³

et al. 2018

Radiation Research

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The risk of a radiological or nuclear public health emergency is a major growing concern of the U.S. government. To address a potential incident and ensure that the government is prepared to respond to any subsequent civilian or military casualties, the U.S. Department of Health and Human Services and the Department of Defense have been charged with the development of medical countermeasures (MCMs) to treat the acute and delayed injuries that can result from radiation exposure. Because of the limited budgets in research and development and the high costs associated with bring promising approaches from the bench through advanced product development activities, and ultimately, to regulatory approval, the U.S. government places a priority on repurposing products for which there already exists relevant safety and other important information concerning their use in humans. Generating human data can be a costly and time-consuming process; therefore, the U.S. government has interest in drugs for which such relevant information has been established (e.g., products for another indication), and in determining if they could be repurposed for use as MCMs to treat radiation injuries as well as chemical and biological insults. To explore these possibilities, the National Institute of Allergy and Infectious Diseases (NIAID) convened a workshop including U.S. government, industry and academic subject matter experts, to discuss the challenges and benefits of repurposing products for a radiation indication. Topics covered included a discussion of U.S. government efforts (e.g. funding, stockpiling and making products available for study), as well unique regulatory and other challenges faced when repurposing patent protected or generic drugs. Other discussions involved lessons learned from industry on repurposing pre-license, pipeline products within drug development portfolios. This report reviews the information presented, as well as an overview of discussions from the meeting.

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Will Purple Become the New orange? the New FDA Purple Book for Biologics: What Does the Future hold?

Cited by 4 publications

References 2 publications

Assessment of the differences between generic and biosimilar drugs: A brief literature review

Assessment of the differences between generic and biosimilar drugs: A brief literature review

Preclinical assessment of abuse liability of biologics: In defense of current regulatory control policies

Challenges and Benefits of Repurposing Products for Use during a Radiation Public Health Emergency: Lessons Learned from Biological Threats and other Disease Treatments

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