Biosimilars: how similar?

Strand, Vibeke; Cronstein, Bruce N.

doi:10.1111/imj.12292

Cited by 25 publications

(9 citation statements)

References 17 publications

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“…A biosimilar is a biological product that is approved based on documented similarity to an existing biological product in terms of quality, safety and efficacy [20,21] . The primary emphasis in biosimilar development is on the evaluation of the similarity in physicochemical structure and biological function between the biosimilar and originator biologic.…”

Section: Biosimilarsmentioning

confidence: 99%

Experience with Biosimilar Infliximab (Remsima®) in Norway

Jahnsen

Jørgensen²

2017

Dig Dis

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Background: The first monoclonal antibody biosimilar to be used in clinical practice is the tumour necrosis factor-alpha inhibitor Remsima® (CT-P13). The drug is approved for all indications as the originator infliximab (Remicade®) although clinical efficacy has been demonstrated only in rheumatic diseases. Since the fall of 2013, Remsima® has been available in Norway and from January 2014, it has been the drug of choice when initiating biological treatment in biologics naïve patients with inflammatory bowel disease (IBD). However, many gastroenterologists have been greatly concerned about the extrapolation of indication. Switching between Remsima® and the innovator product is another issue that has been discussed. Key Messages: Good efficacy, tolerability and safety were demonstrated in a prospective observational study of IBD patients with moderate to severe disease activity. After 14 weeks of treatment there was a significant reduction in the Harvey Bradshaw index in patients with Crohns disease (CD) and reduction in the partial Mayo score and simple clinical colitis activity index in patients with ulcerative colitis. In both patient groups, there was also a significant reduction in fecal calprotectin and C-reactive protein (CRP). In another observational study, IBD patients on maintenance treatment with Remicade® were switched to Remsima®. By comparing values before and after switch, no changes in activity indices, CRP or calprotectin were observed. However, a significant increase in infliximab trough levels was shown in the CD group. No unexpected adverse events occurred after switching. Conclusions: Based on our experience in Norway, Remsima® seems to be efficacious and well tolerated in IBD. The increasing use of Remsima® in clinical practice has also contributed to significant cost savings on the health budget. Results from the NOR-SWITCH study will be available during 2016 and will hopefully contribute to answer some of the important questions that have been raised following the introduction of biosimilars as a treatment option for IBD and other immune-mediated inflammatory diseases.

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Section: Biosimilarsmentioning

confidence: 99%

Experience with Biosimilar Infliximab (Remsima®) in Norway

Jahnsen

Jørgensen²

2017

Dig Dis

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“…The latter are changes a developer makes in its own manufacturing process while all other manufacturing aspects remain constant [19] whereas a BS developer has to set up a new manufacturing process [9,19,24,28] .…”

Section: Manufacturing Process Process Drift and Product Evolution Cmentioning

confidence: 99%

“…Effective, full traceability implies mandatory prescribing by the product's trade name, recording the trade name and the batch number in patients interoperable electronic data so that physicians and pharmacists can access the prescription. Tracked adverse events should be notified immediately for the regulators and the manufacturer to evaluate the quality of the commercial batches [4,19,28,39,50] . Ideally, the PS should be linked to the manufacturing risk management plan of the sponsor.…”

Section: Why a Robust Ps Is Important?mentioning

confidence: 99%

Anti-TNFs: Originators and Biosimilars

Mantzaris

2016

Dig Dis

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In the last 20 years, the advent of anti-tumor necrosis factor alpha (TNFα) biologics has revolutionized the treatment of patients with inflammatory bowel disease (IBD) but the cost of biologic therapy now constitutes a large proportion of all healthcare expenditures. Patent expiration has sparked the healthcare industry's interest in the production of biosimilar (BS) versions of first generation biologics (originators [ORGs]) for market sharing. Having no access to the production line of the ORG, the sponsor of a BS needs to develop his own manufacturing process to produce a highly similar version of the reference product. Similarity in structure, physicochemical properties, biologic activity, efficacy and safety must be demonstrated by a comprehensive comparability exercise that includes the most sensitive in vitro tests, models and clinical condition with pre-defined equivalence margins. Extrapolation of indications, inter-changeability and automatic substitution between BS and ORG depend on a legal framework that varies between different agencies. It is not, therefore, unexpected that marketing authorization by the European Medicines Agency and other regulatory agencies (but not Health Canada) of CT-P13 (Remsima™/Inflectra™) as infliximab (Remicade®) BSs for IBD by indication extrapolation has led to stormy discussions in the IBD community and beyond regarding the scientific adequacy of this decision. However, as we now have to live with BSs, we hope that the impeding automatic substitution in association with post-marketing pharmacovigilance, full traceability, registries and new studies will settle the controversy and will increase the confidence of physicians and patients. A universally adopted legal framework should be implemented because, as expected, the non-anti-TNFα BSs will be soon on the stage.

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“…With approximately eighteen biosimilar products approved in Europe thus far, biosimilars are now becoming a treatment option in the United States. On March 23, 2010, the United States Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) as a means to improve patient accessibility to innovative medical therapies [6]. The BPCIA authorized the FDA to regulate biosimilar drug products acting as an amendment to the Public Health Service Act.…”

Section: Biosimilarsmentioning

confidence: 99%

Hepatitis Foundation International Biosimilars Issue Brief

Cameron¹

2016

JLRDT

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Biosimilars are biological medical products highly similar to the original products manufactured by different pharmaceutical companies. Biosimilars inherit a critical role that addresses the growing need for mechanism-based drugs needed to treat diseases such as hepatitis, HIV and various cancers. In this issue brief, the developmental background, approval process, regulatory review and safety procedures and naming process will be discussed in detail. Benefits and cost to the patient population will also be examined, contrasting how biosimilars can be interchanged or substituted with other drugs to produce near identical health outcomes at affordable prices. Although biosimilar development appears promising, guidelines to proper labeling and surveillance of adverse effects are still being conducted. Patients tend to respond differently to drug therapies, making biosimilars the patient-specific treatment alternative. The Food and Drug Administration (FDA) continues to expand on its recommendations to improve regulation, safety precautions and transparency across all levels of health care for medical providers and their patients.

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Biosimilars: how similar?

Cited by 25 publications

References 17 publications

Experience with Biosimilar Infliximab (Remsima®) in Norway

Experience with Biosimilar Infliximab (Remsima®) in Norway

Anti-TNFs: Originators and Biosimilars

Hepatitis Foundation International Biosimilars Issue Brief

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