Postmarketing Safety of Biosimilars: Current Status, Challenges, and Opportunities in the Spontaneous Reporting System

Singh, Amarendra Pratap; Kalaivani, Mani; Srivastava, Sushma; Goyal, Ramesh K.; Gupta, Suresh

doi:10.1007/s43441-019-00101-6

Cited by 8 publications

(8 citation statements)

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Section: Current State Of Biosimilars In the United States And Europementioning

confidence: 99%

“…Studies show that the EMA and FDA have well-structured pharmacovigilance systems in place, regardless of perception, and the US experience has influenced the development of key models to enhance pharmacovigilance on current practices and future developments. 40,41 Continual robust clinical data will be necessary to ensure ongoing safety and efficacy of biosimilars as scientific and regulatory demands will require awareness and training. FDA and industry should continue to ensure rigorous pharmacovigilance monitoring, including evaluating any product quality concerns.…”

Section: Current State Of Biosimilars In the United States And Europementioning

confidence: 99%

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ASCO Policy Statement on Biosimilar and Interchangeable Products in Oncology

Rodriguez

Mancuso²,

Lyman

et al. 2023

JCO Oncology Practice

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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.

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Section: Current State Of Biosimilars In the United States And Europementioning

confidence: 99%

Section: Current State Of Biosimilars In the United States And Europementioning

confidence: 99%

ASCO Policy Statement on Biosimilar and Interchangeable Products in Oncology

Rodriguez

Mancuso²,

Lyman

et al. 2023

JCO Oncology Practice

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“…In European countries, several national regulatory authorities support substitutability during initial treatment or with the consent of the prescribing physician, but it is not endorsed unequivocally and uniformly [20]. In other countries, interchangeability is treated even differently than in the EU and US [1,21]. Certifying that the drug is interchangeable is very complex for regulators without sufficient supporting data.…”

Section: Interchangeability and Substitutabilitymentioning

confidence: 99%

“…Biological drugs are henceforth referred to as "biologics" in this work. Biologics include various products, such as hormones and enzymes, blood products, and immunological drugs (serums, vaccines, immunoglobulins, allergens, and monoclonal antibodies) [1].…”

Section: Introductionmentioning

confidence: 99%

Pharmacovigilance of Biological Drugs

Guerzoni¹,

Castro²,

Baraldi³

et al. 2023

Pharmacovigilance - Volume 2

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The use of biological drugs has significantly increased over the past decades and has allowed for the treatment of many life-threatening and chronic diseases. The patent expiration of biological innovative medicines enables copies of these drugs called biosimilars. The availability of biosimilars enhances competition, with the potential to improve patient access to biological medications and contribute to the financial sustainability of the healthcare systems. Unlike equivalent drugs, biosimilars are not identical but similar to their innovator products because of the differences in the manufacturing process, which is a biological process. However, they are considered comparable to their originators in safety, quality characteristics, biological activity, and efficacy. The regulatory procedures used for generic drugs cannot be applied for biosimilars, so they are subjected to rigorous characterization as well as comparative clinical studies. Since they are highly complex molecules produced from living cells, even small change in the production process can have major implications on their safety and effectiveness profile, causing a potential risk of immune-based adverse reactions. For all these reasons, for biological drugs, a robust long-term pharmacovigilance system is necessary. It is desirable that in the future, there are further guidance and resolution of the ongoing discussions on biosimilar labeling, naming, pharmacovigilance and interchangeability/substitution, to ensure the appropriate use of these drugs in clinical practice.

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“…Procurement via tendering at the national, regional, or hospital level already occurs in numerous European countries. There is a lack of peer-reviewed published literature to indicate whether crossswitches between biosimilars-due to alternating winners of a competitive bidding processes-have caused efficacy or safety issues of concern [48,49]; however, the stringent pharmacovigilance system used for all biologicals mitigates these safety concerns, as shown in Europe and the USA [50].…”

Section: Rationale For Switches Involving Biosimilarsmentioning

confidence: 99%

Biosimilar-to-Biosimilar Switching: What is the Rationale and Current Experience?

Mysler¹,

Azevedo

Danese

et al. 2021

Drugs

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Over time, clinicians have become increasingly comfortable embracing the prescription of biosimilars-highly similar versions of innovator or reference biological agents-for their patients with inflammatory diseases. Although a switch from a reference product to a licensed biosimilar version (or vice versa) is a medical decision robustly supported by the stepwise accumulation of clinical trial evidence concerning comparable safety, immunogenicity, and efficacy between these products, a switch from one biosimilar to another biosimilar of the same reference product, or a cross-switch, is not. Similarity among biosimilars of a reference product is not a regulatory agency concern and therefore is unlikely to be investigated in randomized controlled trials in the foreseeable future. Yet in clinical practice, across a diverse range of patients, the option to cross-switch from one biosimilar to another can and does arise for valid reasons such as convenience or tolerability issues, or driven by third parties (e.g., payers). In the absence of clinical trial data, clinicians must attempt to objectively evaluate the emerging real-world cross-switching evidence within the context of what is known about the science underpinning a designation of biosimilar. That knowledge then needs to be integrated with what clinicians know about their patients and their disease on a case-by-case basis. This review aims to consolidate relevant emerging real-world data and other key information about biosimilar-to-biosimilar cross-switching for prescribing clinicians. In the absence of clear clinical guidelines addressing this topic at present, this review may serve to facilitate discretionary and educated treatment decision making.

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Postmarketing Safety of Biosimilars: Current Status, Challenges, and Opportunities in the Spontaneous Reporting System

Cited by 8 publications

References 0 publications

ASCO Policy Statement on Biosimilar and Interchangeable Products in Oncology

ASCO Policy Statement on Biosimilar and Interchangeable Products in Oncology

Pharmacovigilance of Biological Drugs

Biosimilar-to-Biosimilar Switching: What is the Rationale and Current Experience?

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