Experience in the Use of the β-Interferon-1a Biosimilars CinnoVex and Genfaxon-44 at the Moscow City Multiple Sclerosis Center

Borets, O. G.; Davydovskaya, M. V.; Demina, T. L.; Lashch, N. Yu.; Popova, N. F.; Попова, Е. В.; Хачанова, Н. В.; Khasaeva, M. V.; Shchur, S G; Бойко, А. Н.

doi:10.1007/s11055-016-0371-1

Cited by 3 publications

(6 citation statements)

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“…21,23 There were high rates of treatment discontinuation owing to perceived efficacy or safety issues after use of two purported interferon-beta 1a biosimilars produced in LRAs. 21…”

Section: Resultsmentioning

confidence: 99%

“…They may have considerable structural differences from their reference products, potentially resulting in different clinical outcomes and/or immunogenicity. 21,23 There were high rates of treatment discontinuation owing to perceived efficacy or safety issues after use of two purported interferon-beta 1a biosimilars produced in LRAs. 21 At minimum, any decision to substitute DMTs at the pharmacy level should be actively communicated to the PwMS and the prescribing clinician.…”

Section: Switching From the Reference Product To An Fo-dmt Is Appropr...mentioning

confidence: 99%

“…21,23 There were high rates of treatment discontinuation owing to perceived efficacy or safety issues after use of two purported interferon-beta 1a biosimilars produced in LRAs. 21 At minimum, any decision to substitute DMTs at the pharmacy level should be actively communicated to the PwMS and the prescribing clinician. In the EU, prescribing practices, including substitution of FO-DMTs at pharmacy level, fall under the responsibility of the member states and are not regulated by the EMA.…”

Section: Switching From the Reference Product To An Fo-dmt Is Appropr...mentioning

confidence: 99%

“…20 Nevertheless, such purported FO-DMTs for MS have been introduced in many LRAs, and their use has become widespread. [20][21][22] Although, a lack of regulation in drug procurement in some LRAs has prevented discernible health cost savings like those seen in other regions. 20,23 There are concerns that the cheaper FO-DMTs are only used to reduce healthcare expenditure, and that the well-being and safety of patients is given a lower priority.…”

Section: Introductionmentioning

confidence: 99%

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Use of follow-on disease-modifying treatments for multiple sclerosis: Consensus recommendations

Brownlee

Wolf²,

Hartung

et al. 2022

Mult Scler

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Background: As patents for multiple sclerosis (MS) therapies expire, follow-on disease-modifying treatments (FO-DMTs) become available at reduced cost. Concerns exist that cheaper FO-DMTs are used simply to reduce healthcare costs. However, the well-being of people with MS should take priority. Objectives: To identify best practices for FO-DMT development and use by agreeing on principles and consensus statements through appraisal of published evidence. Methods: Following a systematic review, we formulated five overarching principles and 13 consensus statements. Principles and statements were voted on by a multidisciplinary panel from 17 European countries, Argentina, Canada and the United States. Results: All principles and statements were endorsed by >80% of panellists. In brief, FO-DMTs approved within highly regulated areas can be considered effective and safe as their reference products; FO-DMTs can be evaluated case by case and do not always require Phase III trials; long-term pharmacovigilance and transparency are needed; there is lack of evidence for multiple- and cross-switching among FO-DMTs; and education is needed to address remaining concerns. Conclusion: Published data support the use of FO-DMTs in MS. The consensus may aid shared decision-making. While our consensus focused on Europe, the results may contribute to enhanced quality standards for FO-DMTs use elsewhere.

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“…21,23 There were high rates of treatment discontinuation owing to perceived efficacy or safety issues after use of two purported interferon-beta 1a biosimilars produced in LRAs. 21…”

Section: Resultsmentioning

confidence: 99%

Section: Switching From the Reference Product To An Fo-dmt Is Appropr...mentioning

confidence: 99%

Section: Switching From the Reference Product To An Fo-dmt Is Appropr...mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Use of follow-on disease-modifying treatments for multiple sclerosis: Consensus recommendations

Brownlee

Wolf²,

Hartung

et al. 2022

Mult Scler

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“…The public and Russian neurological communities, however, have been wary on a perceived reduced efficacy and side effects experienced with foreign-produced biosimilar interferon medications. A study based on patient-event reporting in a Moscow’s cohort comparing CinnoVex ® with another biosimilar interferon-1a (subcutaneous Genfaxon ® 44 mcg) produced by an Argentinean company, disclosed high frequency treatment withdrawal due to perceived clinical failure and subjective intolerance [15]. The Russian government has encouraged local enterprises (i.e., Biocad) to enter the biosimilar industry scenario.…”

Section: International Impact Of Biosimilar Follow-on Medicationsmentioning

confidence: 99%

Biosimilar Drugs for Multiple Sclerosis: An Unmet International Need or a Regulatory Risk?

Rivera

2019

Neurol Ther

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Multiple sclerosis (MS) more than any other neurological disorder has experienced a tremendous progress in available evidence-based innovator disease modifying therapies (DMT). These medications include injectable complex nonbiological drugs (CNBD), the injectable biological products β-interferons-1a and -1b, and the infusible monoclonal antibodies (MAB), as well as oral synthetic therapeutic molecules. The degree of efficacy and adverse effects profile is variable. By the end of 2019, all medications have been approved for relapsing forms of MS, including five with indication for clinically isolated syndrome (CIS), two for active secondary progressive MS, and one for primary progressive MS. With the advent of the first generation or “platform” injectable DMT in the 1990s the cost of MS care increased substantially driven basically by the cost of these therapies. As new drugs licensed by health agencies appeared in the global market, the cost of these agents notably increased augmenting the economic gravamen of disease particularly in North America This industrial phenomenon has been promoted by the remarkable profits obtained by the biopharmaceutical companies producing these medications, costs increasing about seven times per patient per year in the span of two decades. The global MS drug market was valued at US$16.3 billion in 2016, expecting to reach US$27.8 billion by 2025. The societal and economic effect of these costs constitute an international concern for health systems which adjudicate an increasing portion of financial resources to MS care. This effect has had a more notorious impact in emerging countries with economies in development. In the early 2000s the industry producers of biosimilar molecules initiated the concept of manufacturing follow-on biosimilar therapeutic options for MS available at a reduced cost without affecting efficacy and safety. Latin American biotechnological companies from Mexico, Argentina and Uruguay, introduced into the regional markets biosimilar β-interferons. These products were licensed by the local regulatory agencies without challenging pharmacological profile and their claims of similarity with the innovator medications. In the licensing process, biosimilar manufactures have typically utilized published literature and phase III clinical trials data previously acquired by the brand medication (“third approval pathway’’). This has raised concerns among local neurological communities and patient organizations in the area. This situation is compounded by the fact that no discernible health cost savings have resulted since their introduction in Latin American countries. In some European countries where the health care system, public and private systems, regulated by Ministries of Health, negotiate with the pharmaceutical industry drug pricing and payment systems. The business scenario has stimulated local industries to produce follow-on biosimilar medications, theoretically to compete or replace the original brands. Countries such as Iran who have experienced a substantial...

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Interferon-β-1a

2017

Reactions Weekly

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Experience in the Use of the β-Interferon-1a Biosimilars CinnoVex and Genfaxon-44 at the Moscow City Multiple Sclerosis Center

Cited by 3 publications

References 0 publications

Use of follow-on disease-modifying treatments for multiple sclerosis: Consensus recommendations

Use of follow-on disease-modifying treatments for multiple sclerosis: Consensus recommendations

Biosimilar Drugs for Multiple Sclerosis: An Unmet International Need or a Regulatory Risk?

Interferon-β-1a

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