Editorial: Safety considerations of biosimilars

McKinnon, Ross; Ward, Michael

doi:10.18773/austprescr.2016.084

Cited by 11 publications

(9 citation statements)

References 10 publications

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“…There is some concern that switching a patient currently in remission on a biologic to a biosimilar could potentially have uncertain or adverse results ( 11 , 32 ), especially in cases of comorbidity or other complex patient or disease-specific characteristics ( 33 ). Two 2018 meta-analyses of research into clinical outcomes of switching to biosimilars came to different conclusions regarding safety: one concluded that “there are important evidence gaps around the safety of switching” ( 34 ), while the other claimed their results provided reassurance that “the risk of immunogenicity-related safety concerns or diminished efficacy is unchanged after switching from a reference biologic to a biosimilar medicine.” ( 35 ) And another review of 29 studies concerning switching for patients with inflammatory bowel disease concluded that “scientific and clinical evidence is lacking regarding reverse switching, multiple switching and cross-switching among biosimilars” ( 36 ).…”

Section: Biologics and Biosimilarsmentioning

confidence: 99%

The Law and Ethics of Switching from Biologic to Biosimilar in Canada

Murdoch

Caulfield

2020

Journal of the Canadian Association of Gastroenterology

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Governments and financial institutions in several jurisdictions are planning or implementing nonmedical/‘forced’ switches by cutting drug coverage for reference biologics and funding only less expensive biosimilars. Switches raise numerous ethical and legal challenges, as the drugs are framed as not being identical and, despite strong evidence for noninferiority of some biosimilars, there is controversy over whether switching can sometimes lead to adverse events. Canadian law generally requires physicians to give precedence to their patients’ best interests over social interests such as cost containment. The primacy of patients’ interests is also clearly reflected in professional policies and codes of ethics. Moreover, physicians are obligated to disclose everything a reasonable person in the patient’s position would want to know when obtaining informed consent for treatment, including addressing not only scientific information but also relevant social controversy about nonmedical switches. Under Canadian law, physicians may be obligated to tell patients about the ability to access unfunded biologics, even if patients lack the resources to obtain them. In sum, while there is no inherent right to funding for reference biologics in Canada, physicians in some circumstances may have a legal obligation as fiduciaries to advocate on behalf of patients to remain on a reference biologic. At a minimum, the controversy surrounding switching will necessitate, as part of the consent process, a robust and thorough disclosure of relevant risks, benefits and reasonable alternatives.

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Section: Biologics and Biosimilarsmentioning

confidence: 99%

The Law and Ethics of Switching from Biologic to Biosimilar in Canada

Murdoch

Caulfield

2020

Journal of the Canadian Association of Gastroenterology

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“…Though efficient regulations exist for ensuring safety of devices, regular tracking of device manufacturing will complement safety monitoring. [8] While the precision of dosing is a key concern for insulin biosimilars, ease of use, comfort, and convenience of the device are important factors that could potentially influence patient adherence, and so they have an impact on efficacy. [9]…”

Section: Drug-delivery Devices For Biosimilarsmentioning

confidence: 99%

Pharmacovigilance of biosimilars – Why is it different from generics and innovator biologics?

Oza

Radhakrishna

Pipalava

et al. 2019

Journal of Postgraduate Medicine

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Biosimilars are being marketed in India since 2000. Like biologics, biosimilars have a large size, complex structure, and complicated manufacturing process, and they are produced in a living organism. It requires specialized delivery devices for administration and needs tighter temperature control to prevent degradation. As biosimilar development follows abbreviated pathway, adverse events (AEs) previously unknown during a clinical trial may be detected postmarketing. In India, the awareness on pharmacovigilance has increased significantly after implementation of the pharmacovigilance guidance in January 2018. However, biologics require tighter monitoring to ensure their safety and efficacy. This review article discusses the importance of pharmacovigilance for biosimilars, how it is different from generics, and provides recommendations to sensitize clinicians and researchers about the requirement of a different approach to improve pharmacovigilance for biosimilars. Pharmacovigilance for biosimilars is as important as it is for innovator biologics and more important than that for generics.

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“…Safety concerns with biosimilars and biologics involve the potential risk of immune-based adverse reactions and it is important to develop adequate pharmacovigilance measures to adequately address issues of safety and alleviate risks. 22 India has the 3 rd largest pharmaceutical industry in terms of volume in the world.…”

Section: Biosimilarsmentioning

confidence: 99%

Untitled

2019

MOJPH

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140 years later, there is still no known cause, nor cure, for the disease. Treatments to slow progression are available and may help with functioning. Onset of MS remains unclear, however, it is now recognized that MS can arise during childhood or adolescence. 3 MS affects roughly 2.1 million people worldwide with wide geographic variation. In general, observed prevalence is greater at higher latitudes with exceptions (i.e. low rates observed among Chinese, Japanese and Africans; high rates observed among Sardinians, Iranians and Palestinians). 4,5 Diagnoses and treatments: Patients may present with a range of symptoms from cognitive changes to ataxia, depression, visual impairments or hemiparesis. Commonly identified symptoms include:

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Editorial: Safety considerations of biosimilars

Cited by 11 publications

References 10 publications

The Law and Ethics of Switching from Biologic to Biosimilar in Canada

The Law and Ethics of Switching from Biologic to Biosimilar in Canada

Pharmacovigilance of biosimilars – Why is it different from generics and innovator biologics?

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