Iraqi regulatory authority current system and experience with biosimilars

Al-Kinani, Khalid Kadhem; Ibrahim, Mazin Judy; AlZubaidi, Ruaa Fadhil Abbas; Younus, Manal M.; Ramadhan, Samir H; Kadhim, Hussein J; Challand, Rodeina

doi:10.1016/j.yrtph.2020.104768

Cited by 8 publications

(20 citation statements)

References 15 publications

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“…46 An entire cost savings exceeding 50 million USD only in the year of 2020 has been observed due to the approval of various important biosimilar products by the Iraqi National Regulatory Authority along with implementation of guidelines on Iraqi biosimilars. 47 In a study on the budget impact analysis published recently in December 2020, it was concluded that increased use of trastuzumab and rituximab given intravenously resulted in cost savings from the patients' perspective who are paying money for them across the five countries of European Union. 48 Reallocating the funds in the healthcare sector and the problems related to it under the lack of economic support may be an explanation while cost shifting from inpatient departments to ambulatory care department maybe another.…”

Section: Overview Of Economic Impact and Financial Savings From Biosimilar Utilizationmentioning

confidence: 99%

Progress in oncology biosimilars till 2020: Scrutinizing comparative studies of biosimilar monoclonal antibodies

Safdar

Butt

Ahmad

et al. 2021

J Oncol Pharm Pract

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Stupendous elevation in the healthcare costs has followed with the inception of the current unconventional options of treatment available for cancer patients. There is a dire need of innovative financing approaches to lessen the financial load on healthcare system. Biosimilars are biological drugs consisting of an active ingredient from a reference biological drug that has a great potential of relieving financial load. Strict requirements from regulatory point of view are required as biosimilars are exceedingly similar to but not identical to the reference product. This provides with a certainty that no consequential differences from clinical point of view as compared to the respective biologics exists with regards to efficacy, safety and purity. Safety and effectiveness of biosimilars have been disclosed since more than 10 years of affirmations. However, there is a need to educate the healthcare professionals to abolish potential misconceptions and coalesce biosimilars into regular clinical practice. The present review focuses on providing an overview of regulatory aspects and requirements for biosimilars, the main challenges in the selection and development of biosimilars and the economic impact and financial savings observed in recent studies carried out in different parts of the world. In addition, we have discussed the different successful comparative studies which have been done in different parts of the world to depict the biosimilarity for monoclonal antibodies such as bevacizumab, trastuzumab and rituximab.

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Section: Overview Of Economic Impact and Financial Savings From Biosimilar Utilizationmentioning

confidence: 99%

Progress in oncology biosimilars till 2020: Scrutinizing comparative studies of biosimilar monoclonal antibodies

Safdar

Butt

Ahmad

et al. 2021

J Oncol Pharm Pract

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show abstract

“…The Iraqi biosimilars guidelines were adapted mainly from the European Medicines Agency (EMA) guidelines, since EMA was the pioneer in the biosimilars' field. (7) Pharmacist plays an important role in developing biosimilars medicines from synthesis to dispensing to post-marketing pharmacovigilance monitoring. In many countries, pharmacists must be well educated about any new regulations concerning biosimilars.…”

Section: Introductionmentioning

confidence: 99%

Knowledge and Perception of Iraqi Pharmacists Towards Biosimilar Medicines

Mohammed¹,

Kadhim

2021

IJPS

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Abstract Biosimilars are non-innovative copy versions of biologic medicines which are proven to be clinically equivalent to, as effective and as safe as their reference biologics. Biosimilars creates opportunities for cost savings for payers, governments, and patients compared with the reference products. Pharmacist plays an essential role in developing biosimilar medicines from manufacturing to post-marketing pharmacovigilance monitoring. The aim of the current study was to explore the level of knowledge, behaviors and practices of a sample of Iraqi pharmacists towards biosimilar medicines. The current study was a cross sectional, carried out during May 2020. A total of 264 pharmacists )143 male, 121 female) were involved in this study. A web-based self-administered questionnaire was used for data collection . Regarding pharmacists’ knowledge of biosimilar medicines, the results showed that two questions received the highest percentages of adequate answers: biosimilar medicine requires preclinical and clinical studies (58.0%) and biosimilar medicines require more comprehensive data compared to generic drugs (56.1%). In contrast, marketing authorization of biosimilar medicines is granted on the sole investigation of pharmacokinetic bioequivalence received the lowest percentage of adequate answers (21.6%). In addition, the current study showed that more experience years and male gender associated with better knowledge. With respect to perceptions of pharmacists about biosimilar medicines, two statements received the highest percentage of pharmacist agreements: biosimilar medicines are tested in terms of efficacy and safety (64.4%) and biosimilar prescription allows for reducing costs (64.4%). At the same time, 40.2% of the participating pharmacists agreed with pharmacist replacing a reference biologic medicines with its biosimilar product. In conclusion, the majority of the surveyed pharmacists had insufficient knowledge towards biosimilar medicines. The study highlighted that Iraqi pharmacists needed more accurate comprehensive information concerning biosimilar medicines.

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“…The report also indicated that only about 1.24 million US dollars were allocated for procuring medicines, medical appliances, and supplies by the state company for marketing drugs and medical appliances (KIMADIA), a company described in more details later in this section. The Iraqi National Regulatory Authority (NRA) includes several directorates and departments that are parts of the Iraqi MoH, mainly the directorate of technical affairs (DOTA) [6]. The main functions of the Iraqi NRA are associated with ensuring safe, effective, and affordable medicinal products available in Iraq.…”

Section: Introductionmentioning

confidence: 99%

“…These functions include, but are not limited to, granting marketing authorization, estimation of medicines quantities needed to be procured for the Iraqi healthcare institutions, laboratory quality control testing and batch release of medicines, inspection duties, granting pharmaceutical manufacturing licenses, and pharmacovigilance. The Iraqi NRA is led by two supreme committees, the Medicines Policy Committee and the National Board for the Selection of Drugs (NBSD) [6]. The former committee is in charge of establishing the general outlines for medicines policy in the country.…”

Section: Introductionmentioning

confidence: 99%

Essential medicine required for national SRHR guidelines implementation in Iraq

Al-Kinani¹

2021

J Adv Pharm Educ Res

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Iraqi regulatory authority current system and experience with biosimilars

Cited by 8 publications

References 15 publications

Progress in oncology biosimilars till 2020: Scrutinizing comparative studies of biosimilar monoclonal antibodies

Progress in oncology biosimilars till 2020: Scrutinizing comparative studies of biosimilar monoclonal antibodies

Knowledge and Perception of Iraqi Pharmacists Towards Biosimilar Medicines

Essential medicine required for national SRHR guidelines implementation in Iraq

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