As the voice of cancer care clinicians and the patients they serve, ASCO has taken steps to elevate awareness about biosimilar products and their use in oncology. In 2018, ASCO released its Statement on Biosimilars in Oncology which was subsequently published in the Journal of Clinical Oncology to serve as an educational tool which highlighted and provided guidance on several topical areas surrounding biosimilars. At the time of its publication, the US Food and Drug Administration (FDA) had approved eight biosimilar products for use in the United States, including one product for use as a supportive care agent in the cancer setting and two products for use in the treatment for cancer. This number has risen dramatically (40 approvals), with a total of 22 cancer or cancer-related biosimilar products approved since 2015. Recently, the FDA also approved the four interchangeable biosimilar products for diabetes, certain inflammatory diseases, and certain ophthalmic diseases. Given the current market dynamics and the regulatory landscape, this ASCO manuscript now seeks to propose several policy recommendations across the scope of value, interchangeability, clinician barriers, and patient education and access. This policy statement is intended to guide ASCO's future activities and strategies and serves to affirm our commitment to providing education to the oncology community on the use of biosimilars in the cancer setting. 

https://ascopubs.org/doi/pdfdirect/10.1200/OP.22.00783?role=tab

ASCO Policy Statement on Biosimilar and Interchangeable Products in Oncology

Patients' Perceptions of Biosimilars: A Systematic Review.

Background The treatment paradigm for multiple sclerosis (MS), particularly relapsing-remitting MS, is heavily reliant on biologic disease-modifying therapies (DMTs). However, the current cost of treatment acts as a significant barrier to access for patients. Over the next few years exclusivity periods for key biologic medicines used in MS are likely to end, opening the door for biosimilar medicines to enter the market. Methods In this review, we discuss what biosimilar medicines are, and how the existing experience with biosimilar medicines across multiple therapy areas can inform the assimilation of biosimilar medicines into the MS treatment landscape in Europe and the US. Results There is currently a lack of knowledge and awareness around the distinctions and similarities between small molecules, non-biological complex drugs, and biological medicines, as well as the different categories of follow-on successor medicines. These include biosimilar medicines that offer a matching efficacy and safety profile to the reference biologic. Understanding and recognition of the stringency of the approval pathways required for drug categories such as biosimilars are key in building confidence in treatment outcomes. For example, biosimilar medicines are sometimes perceived only as ‘copies’ of their reference biologic despite undergoing an extensive approval process requiring that no clinically meaningful differences are observed between the biosimilar medicine and the reference medicine. For MS, introduction of biosimilar medicines in the future will enable more people with MS to receive effective treatment, and also expand access to biologic DMTs in MS. Experiences from the use of biosimilars in multiple therapy areas have shown us that this can result in cost-saving benefits for a healthcare system. Introduction of biosimilar medicines in other therapy areas has also demonstrated the importance of appropriate, accurate education and information for their successful integration into clinical practice. Conclusion In order to realize optimized treatment outcomes in MS in coming years and to find the appropriate place for biosimilar medicines in the changing MS landscape, it is essential that clinicians and people with MS understand the fundamentals of biosimilars, their potential benefits and consistency of treatment provided by a biosimilar medicine, given the matching efficacy and safety profile to its reference medicine. As evidenced in other therapy areas, biosimilar medicines may reduce key barriers to access by providing a cost-effective alternative to the MS treatment arsenal, while providing the same treatment outcomes as reference biologics. 

A place for biosimilars in the changing multiple sclerosis treatment landscape

Biosimilars represent an opportunity to realise savings against the costs of innovative medicines. Despite efforts made by stakeholders, there are numerous barriers to the uptake of biosimilars. To realise the promise of biosimilars reducing costs, barriers must be identified, understood, and overcome, and enablers magnified. The aim of this systematic review is to summarise the enablers and barriers affecting uptake of biosimilars through the application of a classification system to organise them into healthcare professional (HCP), patient, or systemic categories. A systematic literature search was performed in PubMed, Scopus, CINAHL, eConlit, and Embase. Included were primary research studies published in English between Jan 2017 through June 2023 focused on enablers and barriers affecting uptake of biosimilars. Excluded studies comprised comparisons of biosimilar efficacy and safety versus the reference biologic. One reviewer extracted data that included classification of barriers or enablers, the sub-classification, and the identification of the degree of agency associated with the actor through their role and associations as a mediator within their network, through the application of Actor Network Theory. The data were validated by a second reviewer (PV). Of the 94 studies included, 59 were cross-sectional, 20 were qualitative research, 12 were cohort studies, and three were economic evaluations. Within the review, 51 of the studies included HCP populations and 35 included patients. Policies and guidelines were the most cited group of enablers, overall. Systemic enablers were addressed in 29 studies. For patients, the most frequently cited enabler was positive framing of a biosimilar, while for HCPs, cost benefit was the most frequently noted enabler. The most frequently discussed systemic barrier to biosimilar acceptance was lack of effective policies or guidelines, followed by lack of financial incentives, while the most significant barriers for HCPs and patients, respectively, were their lack of general knowledge about biosimilars and concerns about safety and efficacy. Systemic actors and HCPs most frequently acted with broad degree of agency as mediators, while patient most frequently acted with a narrow degree of agency as mediators within their networks. Barriers and enablers affecting uptake of biosimilars are interconnected within networks, and can be divided into systemic, HCP, and patient categories. Understanding the agency of actors within networks may allow for more comprehensive and effective approaches. Systemic enablers in the form of policies appear to be the most effective overall levers in affecting uptake of biosimilars, with policy makers advised to give careful consideration to appropriately educating HCPs and positively framing biosimilars for patients. 

pdf/barriers-and-enablers-affecting-the-uptake-of-biosimilar-1op475wxoy.pdf

Barriers and Enablers Affecting the Uptake of Biosimilar Medicines Viewed Through the Lens of Actor Network Theory: A Systematic Review

Biosimilars are biological drugs created from living organisms or that contain living components. They share an identical amino‐acid sequence and immunogenicity. These drugs are considered to be cost‐effective and are utilized in the treatment of cancer and other endocrine disorders. The primary aim of biosimilars is to predict biosimilarity, efficacy, and treatment costs; they are approved by the Food and Drug Administration (FDA) and have no clinical implications. They involve analytical studies to understand the similarities and dissimilarities. A biosimilar manufacturer sets up FDA‐approved reference products to evaluate biosimilarity. The contribution of next‐generation sequencing is evolving to study the organ tumor and its progression with its impactful therapeutic approach on cancer patients to showcase and target rare mutations. The study shall help to understand the future perspectives of biosimilars for use in gastro‐entero‐logic diseases, colorectal cancer, and thyroid cancer. They also help target specific organs with essential mutational categories and drug prototypes in clinical practices with blood and liquid biopsy, cell treatment, gene therapy, recombinant therapeutic proteins, and personalized medications. Biosimilar derivatives such as monoclonal antibodies like trastuzumab and rituximab are common drugs used in cancer therapy. Escherichia coli produces more than six antibodies or antibody‐derived proteins to treat cancer such as filgrastim, epoetin alfa, and so on.

Cancer treatment with biosimilar drugs: A review

To characterize current experiences with communication and decision-making practices when non-medical switching to a biosimilar trastuzumab is proposed or required by cancer center or insurer.We developed and launched 60- and 51-item internet surveys to elicit US breast cancer patient and medical oncologist lived experiences with trastuzumab biosimilars and patient information needs and seeking practices. We recruited participants using social media and administered via REDCap in 2020-2021.143 breast cancer patients and 33 medical oncologists completed the surveys. 63.9% patients reported having switched to a trastuzumab biosimilar and 40.8% reported receiving no prior notification about switching. 44% of patients reported learning about biosimilars primarily through self-directed learning and 41% wanting more time to discuss with oncologist. None of the oncologists reported that the decision to switch a patient to a biosimilar was initiated by them, but rather more frequently by the insurer (45.2%). About 54.8% reported not receiving any pharmaceutical manufacturer material related to the selected biosimilar. Patients and oncologists diverged in their responses to items regarding patient opportunities to ask questions, adequacy of resources, effectiveness of treatment, patient worry, and magnitude of change.There is a need for tailored and effective patient and oncologist information and education on trastuzumab biosimilars, along with improved healthcare communication regarding switching. The discrepancy between patient-reported experiences and oncologist perceptions of the patient experience, suggests a lack of adequate information that may be a challenge not only to the uptake of trastuzumab biosimilars, but to the patient-oncologist relationship. 

https://link.springer.com/content/pdf/10.1007/s10549-022-06615-2.pdf

Characterizing experiences of non-medical switching to trastuzumab biosimilars using data from internet-based surveys with US-based oncologists and breast cancer patients


 Although the uptake of trastuzumab biosimilars to treat HER2-positive breast cancer is growing, knowledge gaps remain for both, patients and clinicians. In a mixed-methods study, inconsistencies in terminology used to describe trastuzumab biosimilars. We analyzed open-ended questions from surveys (n = 143 breast cancer patients, n = 33 medical oncologists) and interviews (n = 8 patients, n = 4 oncologist, nurse, pharmacists) indentifying terminology as an a priori (top-down) category for qualitative thematic analysis. We specifically looked for examples of inconsistent or incorrect use of terminology in the interviews. Findings suggest that 1) terminology used to refer to trastuzumab biosimilars is variable across patients and some is not representative of the formal definition (e.g. generic, generic-like, interchangeable, Herceptin, generic Herceptin (as per how their oncologist refers to biosimilars) and 2) clinicians discussed the challenges of talking about biosimilars in a manner that is both understandable to patients and accurate. Specifically, one pharmacist highlighted concerns around this complexity and suggested that it should be part of clinician education to use the correct terminology, rather than using the term generic. A medical oncologist said that “Explaining biosimilars to a patient can be challenging” as part of their survey response. Lack of consistent terminology for trastuzumab biosimilars is a potential barrier to effective patient-clinician communication on this topic and may perpetuate lack of comprehension on the part of patients. Further, the intentional use (to make information more digestible to patients) of incorrect terminology by clinicians has the potential to negatively impact the patient-clinician relationship in cases where patients identify conflicting information on their own. The adoption of terminology that is consistent across clinicians and patient-facing resources on the introduction and description of trastuzumab biosimilars, may serve to facilitate common grounding among all roles.
 Citation Format: Elizabeth Papautsky, Devika Salunke, Hannah Montague, Martha Carlson, Sheila Johnson, Deanna Attai, Maryam Lustberg. Using Mixed Methods to Examine Clinician and Patient Use of Terminology to Describe Trastuzumab Biosimilars [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-09-05.

Abstract P6-09-05: Using Mixed Methods to Examine Clinician and Patient Use of Terminology to Describe Trastuzumab Biosimilars

Abstract Despite the incorporation of trastuzumab biosimilars (to treat HER2-positive breast cancer) in clinical practice guidelines, gaps remain such as patient and clinician education. We hosted a webinar comprised of a panel of biosimilars experts, oncologists, pharmacist, infusion nurse, and a patient advocate. The outcomes of the webinar include audience responses to pre- and post-webinar questionnaires, educational benefits, real-time opportunities to ask questions, and a recording. Education needs to be tailored to the needs of both, patients and clinicians.

Webinar as an Informational Resource on Trastuzumab Biosimilars: Planning, Promotion, Execution, and Evaluation

Handle everyday research tasks with reliable, citation-backed results

Your personal Research Agent to handle research tasks with citation-backed results

Popular Tasks used by Researchers

How can I help with your research?

Meet SciSpace

Get more enhanced response by uploading the PDFs you want me to reference.

No relevant PDFs in your library

SciSpace is the AI research assistant for academics. Run systematic literature reviews on 280M+ papers, and write papers with cited sources. Trusted by 1M+ students, PhDs & researchers.

SciSpace | AI for Research

Analyze PDFs

Code & Manuscripts

Funding & Grants

Literature & Patents

Medical & Clinical Data

Systematic Review

Visualize & Present

Web & Data

Build a Google Scholar-like website for your research.

Build a website

Create charts and images for your research

Create a Chart

Write a paper for submission to a journal

Draft a manuscript

Patent Search

Design eye-catching scientific posters in minutes.

Scientific Poster Generation

Systematic Literature Review

One task is running at the moment. Your messages will be shown right after.

Drag and drop or click here to browse

Loved by <highlight>1 million+</highlight> researchers

Extract a list of specific topics and their sources from unstructured text

Topics

Compare and analyze relevant papers that matches with your search

Papers

Get insights from PDFs and bookmarked papers from your library

My library

Recent searches

Try searching for:

Catch AI-generated content in scholarly and non-scholarly content

{ai} Detector

Ai Writer

Get PDF Summaries, highlighted text explanations 

Chat with PDF

Effortlessly create in-text citations and bibliographies in APA and 2,500 other formats

Citation generator

Get explanations, summaries, and answers on academic papers

Ease up your research workflow with {scispace}'s cohort of exciting AI tools

Elevate your academic writing skills and convey your ideas the way you want

Paraphraser

Explore our range of reading and writing tools

Your file is being prepared and should be ready in a few minutes. If it's a large file, it might take a bit longer. You can close this window, and we'll email you the file when it's done.

You have reached a maximum limit of <strong>{limit}</strong> columns in the table. Remove at least <strong>1</strong> column to add or create another one.

S. Johnson

Author Tools

Chat about Author

Papers

Characterizing experiences of non-medical switching to trastuzumab biosimilars using data from internet-based surveys with US-based oncologists and breast cancer patients

Abstract P6-09-05: Using Mixed Methods to Examine Clinician and Patient Use of Terminology to Describe Trastuzumab Biosimilars

Webinar as an Informational Resource on Trastuzumab Biosimilars: Planning, Promotion, Execution, and Evaluation