American Society of Clinical Oncology Statement: Biosimilars in Oncology

Lyman, Gary H.; Balaban, Edward P.; Diaz, Michael; Ferris, Andrea; Tsao, Anne S.; Voest, Emile E.; Zoň, Robin; Francisco, Michael; Green, Sybil; Sherwood, Shimere; Harvey, R. Donald; Schilsky, Richard L.

doi:10.1200/jco.2017.77.4893

Cited by 95 publications

(105 citation statements)

References 2 publications

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“…Despite the increasing use of internet health information by patients, one survey found that perceived physician quality had a greater impact on treatment compliance than the perceived quality of internet health information [178], emphasizing the importance of HCP communication. In addition, educational materials developed by medical societies or government organizations, in conjunction with patient groups, could play a key role in supporting patient education about biosimilars, as recognized in the oncology setting [179].…”

Section: Patients' Perspective: Improved Information Sharing May Encomentioning

confidence: 99%

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Kim

Alten

Avedano³

et al. 2020

Drugs

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Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Biosimilars-biologic medicines with no clinically meaningful differences in safety or efficacy from licensed originators-can stimulate market competition and have the potential to expand patient access to biologics within the parameters of treatment recommendations. However, maximizing the benefits of biosimilars requires cooperation between multiple stakeholders. Regulators and developers should collaborate to ensure biosimilars reach patients rapidly without compromising stringent quality, safety, or efficacy standards. Pharmacoeconomic evaluations and payer policies should be updated following biosimilar market entry, minimizing the risk of imposing nonmedical barriers to biologic treatment. In RA, disparities between treatment guidelines and national reimbursement criteria could be addressed to ensure more uniform patient access to biologics and enable rheumatologists to effectively implement treat-to-target strategies. In IBD, the cost-effectiveness of biologic treatment earlier in the disease course is likely to improve when biosimilars are incorporated into pharmacoeconomic analyses. Patient understanding of biosimilars is crucial for treatment success and avoiding nocebo effects. Full understanding of biosimilars by physicians and carefully considered communication strategies can help support patients initiating or switching to biosimilars. Developers must operate efficiently to be sustainable, without undermining product quality, the reliability of the supply chain, or pharmacovigilance. Developers should also facilitate information sharing to meet the needs of other stakeholders. Such collaboration will help to ensure a sustainable future for both the biosimilar market and healthcare systems, supporting the availability of effective treatments for patients.

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Section: Patients' Perspective: Improved Information Sharing May Encomentioning

confidence: 99%

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Kim

Alten

Avedano³

et al. 2020

Drugs

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“…However, interchangeability is not automatically granted upon approval of a biosimilar; additional evidence is required to demonstrate that the clinical result achieved with the biosimilar is expected to be the same as the reference product. In addition, switching treatment between the reference product and biosimilar should demonstrate no increased risk to the patient …”

Section: Regulatory Approval Of Biosimilars: Global Versus Latin Amermentioning

confidence: 99%

Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey

Castañeda‐Hernández

Sandoval

Coindreau

et al. 2019

Pharmacoepidemiology and Drug

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Purpose This review summarises the current status of regulatory guidelines for the approval of biosimilars in Latin America and highlights the main barriers to effective pharmacovigilance in this region. We also report results from a survey of Latin American rheumatologists assessing their understanding of prescribing biosimilars and the pharmacovigilance of these drugs. Methods We reviewed the current guidelines for the regulatory approval of biosimilars and barriers to effective pharmacovigilance in Latin American countries. Rheumatologists attending the II Pan‐American League of Rheumatology Associations PANLAR Review Course (Biosimilars update) in Lima, Peru were asked to complete a short survey to determine their knowledge of biosimilars. Results Many Latin American countries continue to lag behind Europe and the United States in establishing regulatory guidance and effective pharmacovigilance systems for biosimilars. Results from our survey also highlight a lack of awareness regarding the availability of biosimilars, their nomenclature, automatic substitution, and reporting adverse drug reactions because of these drugs. Conclusions The main barriers to effective pharmacovigilance in Latin America are the lack of consensus on the interchangeability of reference biologics and biosimilars, and the need for more suitably trained personnel to carry out effective postmarketing pharmacovigilance of biosimilars. Inconsistencies in biosimilar nomenclature make it difficult to adequately trace drugs and record adverse drug reactions associated with their use, creating a barrier to the global pharmacovigilance of biologics.

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“…the assessment of a licensed biologic that has undergone a manufacturing process change) [16,47,48]. Educational materials released by the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA), as well as initiatives from medical societies emphasize the need to increase understanding of biosimilars among patients and healthcare professionals [49][50][51].…”

Section: Expert Opinionmentioning

confidence: 99%

Development pathways for subcutaneous formulations of biologics versus biosimilar development

Zharkov

Barton

Heinzmann

et al. 2019

Expert Review of Precision Medicine and Drug Development

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Introduction: Biologics are highly complex drugs and many of their characteristics are defined by the manufacturing process. In recent years, several monoclonal antibody (mAb) biologics, which were hitherto only available for intravenous (IV) administration, have been reformulated for subcutaneous (SC) administration. Reformulation involves alterations to the established manufacturing process and it has been argued that a SC formulation should therefore be considered a biosimilar version of its previously approved IV formulation. Areas covered: Developing an SC version of an approved IV mAb product requires the adaptation of its formulation and route of administration. This process is illustrated via case examples of trastuzumab and rituximab and summarize what data requirements support the regulatory approval of these new formulations. Furthermore, we discuss similarities and differences between the development of an SC product vs. the development of a biosimilar. Expert opinion: The production process of a biosimilar is independently established from the very beginning, while the development of an SC formulation affects later stages of an already established production process and builds on extensive experience with the IV formulation. Considering these fundamentally different situations, a biologic product reformulated for SC administration should not be considered a 'biosimilar' version of itself. ARTICLE HISTORY

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American Society of Clinical Oncology Statement: Biosimilars in Oncology

Cited by 95 publications

References 2 publications

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey

Development pathways for subcutaneous formulations of biologics versus biosimilar development

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