Dataset Information

Biosimilars in ophthalmology: "Is there a big change on the horizon?"

ABSTRACT: Retinal disease management has witnessed remarkable advances in posterior segment pharmacotherapy with the development of anti-VEGF molecules such as Lucentis® (ranibizumab), Eylea® (aflibercept), and off-label bevacizumab (Avastin). The US patents for ranibizumab and aflibercept will expire in 2020 (though Regeneron has indicated that it might attempt to extend its US patent to June 2023 with additional patent claims), and their European patents will expire in 2022 and 2025. Aflibercept comes off patent in 2022 in People's Republic of China and Japan. As soon as each patent expires, biosimilar molecules could potentially come in the mainstream clinical practice as a more cost-efficient choice in the form of generic biosimilars. It is difficult to predict how significant this shift would be in terms of more cost-effective clinical management and how it will impact the care in developed and developing world. It is important for clinicians to have a clear understanding about ophthalmic biosimilars before the industry brings these molecules to the mainstream clinical use globally.

SUBMITTER: Sharma A

PROVIDER: S-EPMC6207386 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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Biosimilars in ophthalmology: "Is there a big change on the horizon?"

Sharma Ashish A Reddy Prahalad P Kuppermann Baruch D BD Bandello Francesco F Lowenstein Anat A

Clinical ophthalmology (Auckland, N.Z.) 20181024

Retinal disease management has witnessed remarkable advances in posterior segment pharmacotherapy with the development of anti-VEGF molecules such as Lucentis<sup>®</sup> (ranibizumab), Eylea<sup>®</sup> (aflibercept), and off-label bevacizumab (Avastin). The US patents for ranibizumab and aflibercept will expire in 2020 (though Regeneron has indicated that it might attempt to extend its US patent to June 2023 with additional patent claims), and their European patents will expire in 2022 and 202 ...[more]

PMID: 30498330

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Project description:Background Biosimilars can improve patient access to biological medicines. Although biosimilars have been shown to be equally effective and safe, some patients remain reluctant to transition to biosimilars. Pharmacists may support patients changing to biosimilars and are often at the frontline for dealing with queries and concerns, but their confidence and readiness for this role are unclear. Objective This study examines pharmacists' confidence in explaining biosimilars to patients and explores the information they would provide in response to common queries. Methods Practicing community, hospital, and primary care pharmacists (N = 142) in New Zealand completed an Internet-based survey on their experience and familiarity with bio-originators and biosimilars, attitudes and concerns towards biosimilars, confidence in explaining key concepts, and responses to common queries. A hierarchical linear regression was conducted to examine possible factors associated with confidence in explaining biosimilars, and a content synthesis was conducted to examine responses to common patient queries. Results Pharmacists were most confident in explaining how biosimilars are administered, their efficacy, and cost-saving, and least confident in describing manufacturing and testing. Respondents who had more positive attitudes (B = 1.64, p < .001) and more familiarity with biosimilars (B = 27.15, p < .001) were more confident in educating patients. Pharmacists' main concerns about biosimilars included reduced efficacy, safety, and a lack of knowledge and acceptance. Responses to common queries were diverse but further highlighted several gaps in knowledge. Gaps included being unable to define biosimilars, provide information on side effects, and believing that biosimilars undergo the same testing process as bio-originators. Pharmacists wanted resources (written and Internet-based) to improve their knowledge and ability to educate patients. Conclusions Pharmacists reported a lack of knowledge and confidence in explaining manufacturing processes and testing of biosimilars. Additional resources are needed to support their practice and may help improve patient and companion acceptance of biosimilars. Highlights • Pharmacists often help to educate patients about biosimilars and address their concerns.• Some pharmacists lack confidence in explaining key concepts, which could deter patients from accepting biosimilars.• Additional resources and guidance are needed to improve their knowledge and ability to educate patients.

Dataset Information

Biosimilars in ophthalmology: "Is there a big change on the horizon?"

Publications

Biosimilars in ophthalmology: "Is there a big change on the horizon?"

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