Biosimilars: Clinical Interpretation and Implications for Drug Development

Mysler, Eduardo

doi:10.1007/s11926-014-0483-y

Cited by 3 publications

(9 citation statements)

References 15 publications

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“…Development of these novel biologic drugs is extremely technical and challenging, taking~7 --8 years and a minimum of 100 --250 million dollars [25]. Due to their complex structures and the complexity of manufacturing these drugs, there can be micro-variability even with slight changes in the production process between batches of the same biologic drug [26][27][28][29]. Currently, there are over 900 biologic drugs and biosimilar drugs in various phases of clinical development and approval, representing~30% of the drugs currently in the pharmaceutical and biotechnology research and development pipelines [30,31].…”

Section: Biologic Drugsmentioning

confidence: 99%

“…The dose, route of administration, safety profile and primary amino acid sequence must be identical, and they can only be approved for the same indications as the reference drug [26,29]. Minor modifications, such as N-or C-terminal truncations may be accepted as long as they do not affect performance [51,54].…”

Section: Biosimilar Drugs In Developmentmentioning

confidence: 99%

“…As part of the drug development process, pharmacokinetic and pharmacodynamic studies must be performed [29]. Pharmacokinetic studies must generally demonstrate results within a prespecified margin [29].…”

Section: Biosimilar Drugs In Developmentmentioning

confidence: 99%

Section: Biosimilar Drugs In Developmentmentioning

confidence: 99%

“…Pharmacokinetic studies must generally demonstrate results within a prespecified margin [29]. When biomarkers are available, pharmacodynamics are measured, and the results should be similar [29]. The preferred method for clinical trials of biosimilars is an equivalence trial, where the study specifies superior and inferior margin limits and the biosimilar drug candidate is compared with the reference drug in a head-to-head manner [29,50,54].…”

Section: Biosimilar Drugs In Developmentmentioning

confidence: 99%

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An overview of developing TNF-α targeted therapy for the treatment of psoriasis

Campa

Ryan

Menter

2015

Expert Opinion on Investigational Drugs

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The currently approved TNF-α antagonists benefit from over 10 years of safety and efficacy data. The expense and method of administration of these biologics, however, can be cumbersome, and less expensive alternatives have the potential to benefit patients with psoriasis. It is inevitable, despite the introduction of new anti-IL-17 therapies, that established TNF-α targeted therapies, as well as newcomers targeting TNF-α, will continue to play an important role in the lifelong management of psoriasis.

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Section: Biologic Drugsmentioning

confidence: 99%

Section: Biosimilar Drugs In Developmentmentioning

confidence: 99%

Section: Biosimilar Drugs In Developmentmentioning

confidence: 99%

Section: Biosimilar Drugs In Developmentmentioning

confidence: 99%

Section: Biosimilar Drugs In Developmentmentioning

confidence: 99%

See 3 more Smart Citations

An overview of developing TNF-α targeted therapy for the treatment of psoriasis

Campa

Ryan

Menter

2015

Expert Opinion on Investigational Drugs

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Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology

Mysler¹,

Pineda

Horiuchi

et al. 2016

Rheumatol Int

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Biologics are vital to the management of patients with rheumatic and musculoskeletal diseases such as rheumatoid arthritis and other inflammatory and autoimmune conditions. Nevertheless, access to these highly effective treatments remains an unmet medical need for many people around the world. As patents expire for existing licensed biologic (originator) products, biosimilar products can be approved by regulatory authorities and enter clinical use. Biosimilars are highly similar copies of originator biologics approved through defined and stringent regulatory processes after having undergone rigorous analytical, non-clinical, and clinical evaluations. The introduction of high-quality, safe, and effective biosimilars has the potential to expand access to these important medicines. Biosimilars are proven to be similar to the originator biologic in terms of safety and efficacy and to have no clinically meaningful differences. In contrast, “intended copies” are copies of originator biologics that have not undergone rigorous comparative evaluations according to the World Health Organization recommendations, but are being commercialized in some countries. There is a lack of information about the efficacy and safety of intended copies compared with the originator. Furthermore, they may have clinically significant differences in formulation, dosages, efficacy, or safety. In this review, we explore the differences between biosimilars and intended copies and describe key concepts related to biosimilars. Familiarity with these topics may facilitate decision making about the appropriate use of biosimilars for patients with rheumatic and musculoskeletal diseases.

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