Iraqi J Pharm Sci, Vol.30(1) 2021 Knowledge and perception towards biosimilars DOI: https://doi.org/10.31351/vol30iss1pp226-232 226 Knowledge and Perception of Iraqi Pharmacists Towards Biosimilar Medicines Ashwaq J. Mohammed*,1 and Dheyaa J. Kadhim** * Ministry of Health and Environment , Iraq. **Department of Clinical Pharmacy, College of Pharmacy, University of Baghdad, Baghdad, Iraq. Abstract Biosimilars are non-innovative versions of biologic medicines which are proven to be clinically equivalent to, as effective, and as safe as their reference biologics. Biosimilars create opportunities for cost savings for payers, governments, and patients compared to the reference products. Pharmacists play an essential role in developing biosimilars from manufacturing to post-marketing pharmacovigilance monitoring. The aim of the current study was to explore the level of knowledge and perception of a sample of Iraqi pharmacists towards biosimilars. The current study was a cross sectional and was 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 years of experience and male gender were associated with better knowledge. With respect to perceptions of pharmacists to biosimilars, 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 pharmacists included in the survey had insufficient knowledge about biosimilars. The study highlighted that Iraqi pharmacists needed more accurate and comprehensive information about biosimilars. Keywords: Biosimilars, Pharmacists, Iraq, Knowledge, Perception. معرفة وتصور الصيادلة العراقيين تجاه المشابهات الحيوية **و ضياء جبار كاظم 1،*شواق جاسم محمدأ العراق.والبيئة ، وزارة الصحة * .بغداد، بغداد، العراق الصيدلة، جامعة السريرية، كلية الصيدلة فرع ** الخالصة االحيائية االحيائية التي ثبت علميًا أنها مكافئة سريريًا ، وفعالة وآمنة مثل األدوية هي نسخ غير مبتكرة من األدوية الحيوية المشابهات يلعب الصيدلي .في التكاليف للدافعين والحكومات والمرضى ، مقارنة بالمنتجات المرجعية توفيرفرًصا لتحقيق الحيوية المشابهاتتخلق . المرجعية .بدًءا من التصنيع حتى دراسات اليقظة الدوائية وما بعد التسويق الحيوية المشابهاتدوًرا مهًما في تطوير الدراسة الحالية .الحيوية المشابهاتمن الصيادلة العراقيين تجاه لعينةتصورات استكشاف مستوى المعرفة والكان الهدف من الدراسة الحالية هو تم استخدام استبيان عبر (. أنثى 121ذكًرا و 143)صيدليًا 264شارك في هذه الدراسة .2020 عبارة عن دراسة مقطعية أجريت خالل شهر ايار النسب المئوية ، أظهرت النتائج أن سؤالين تلقيا أعلى الحيوية المشابهاتبفيما يتعلق بمعرفة الصيادلة . المتعلقة بالدراسةاإلنترنت لجمع البيانات تتطلب بيانات أكثر شموالً مقارنة الحيوية المشابهاتو ( ٪58.0)تتطلب دراسات ما قبل السريرية والسريرية الحيوية المشابهات: لإلجابات الكافية بناًء على تحقيق وحيد للتكافؤ الحيوي الدوائي حصل على أقل الحيوية المشابهاتفي المقابل ، يُمنح ترخيص تسويق ( . ٪56.1)دوية الجنيسة باأل باإلضافة إلى ذلك ، أظهرت الدراسة الحالية أن المزيد من سنوات الخبرة وجنس الذكور مرتبطان بمعرفة (. ٪21.6)نسبة من اإلجابات الكافية من الحيوية المشابهاتتم اختبار :، حصل بيانان على أعلى نسبة من اتفاق الصيادلة الحيوية المشابهاتفيما يتعلق بتصورات الصيادلة حول . أفضل المشاركين ٪ من الصيادلة 40.2في الوقت نفسه ، اتفق (. ٪64.4)يسمح بخفض التكاليف الحيوية المشابهاتووصف ( ٪64.4)حيث الفعالية واألمان غالبية الصيادلة الذين شملهم االستطالع كنتيجة فأن .الحيوية المشابهاتاالحيائية المرجعية بمنتج من على امكانية قيام الصيدالني باستبدال األدوية المشابهاتمات دقيقة وشاملة عن سلط المسح الضوء على الحاجة إلى تزويد الصيادلة العراقيين بمعلو. الحيوية المشابهاتبلم تكن لديهم معرفة كافية .الحيوية تصور. ، معرفة، العراق ،الصيادلة، الحيوية المشابهات الكلمات المفتاحية: 1Corresponding author E-mail: winterice1010@gmail.com Received: 5/10/2020 Accepted: 5/12 /2020 Iraqi Journal of Pharmaceutical Science https://doi.org/10.31351/vol30iss1pp226-232 Iraqi J Pharm Sci, Vol.30(1) 2021 Knowledge and perception towards biosimilars 227 Introduction The introduction of biologic medicines represented a significant development in therapy for many serious diseases. (1) Despite their important value, biologic medicines have become a big financial problem to the health care systems. (2) Therefore, availability of “generic” copy of biological medicines would be essential as this could save billions of dollars yearly. (3) The U.S. Food and Drug Administration (FDA) defines a biosimilar product as highly similar but not identical to an already licensed biologic product in terms of quality, safety, and efficacy. (4) Costs of biosimilars are about 15–30% less than the originator prices so their use creates opportunities for cost savings for payers, governments, and patients compared with the reference products since. (5) Biologic medicines are big molecules that are mostly proteins. The manufacturing of biologic medicines is very complex which required living cells; so variation in the final product is a concern. Post-translational modifications such as oxidation and glycosylation and even a small variation in the manufacturing process can change the structure of biologic medicines, with possible changing in pharmacological activity, safety profile, efficacy, and immunogenicity. Accordingly, the manufacturing of biologic medicines must be closely monitored so that consistency of batch to batch will be ensured. Consequently, it is almost difficult to synthesize a biologic medicine that is identical to its originator. (6) In Iraq, a specialized committee called the ‟Biologics and Biosimilars Registration Committee (BBRC)” to register biosimilars was established by the National Regulatory Authority (NRA). The BBRC established the first version of guideline for biosimilars and submitted it to the Medicines Policy Committee for approval on April 28th of 2019. 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. In addition, pharmacists are involved in educating physicians and patients about similarity, efficacy and safety of biosimilar medicines. (8) 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. Subjects and Method Study population The current study was a cross sectional study carried out during May 2020. A total of 264 Iraqi pharmacists (143 males, 121 females) were involved in this study. Inclusion criteria Any Iraqi pharmacist willing to participate in the study were included. Data collection A web-based, self-administered, questionnaire was used for data collection. The questionnaire investigates knowledge, behaviors and practices of pharmacists regarding biosimilar medicines. It consisted of three parts, the first part was about the sociodemographic and background characteristics of the participants. The second part addressed the knowledge of pharmacists about biosimilar medicines, this included 9 statements about quality, safety, efficacy and marketing authorization. Knowledge domain have response categories of (Yes, No, and Don’t know). The third part (6 questions) were used to investigate pharmacists perceptions about biosimilar medicines, implementation of biosimilar medicines, substitution, and cost saving. The agreement of participants and attitude domains have five Likert scale response categories. (9) Ethical consideration The current study gained its approval from the ethical and scientific committee at the College of Pharmacy/University of Baghdad. All participants were informed about the study objectives and confidentiality of their answers. Statistical analysis Analyses were conducted using the Statistical Package for the Social Science (SPSS, version 22, IBM, New York, USA). Descriptive statistics (Categorical variable) were described using frequencies and percentages while, mean and standard deviation (SD) were used to describe (continuous variables) of the participants. Independent T-test was used to measure the difference between the means of accurate answer scores according to gender. We excluded “not sure” group from the analysis. The total score of correct answers for each participants was calculated by giving one point for each correct answer. Spearman correlation was used to measure the correlation between the pharmacist experience years and the mean of total score of correct answers to questions about biosimilar medicines. A p-value of less than 0.05 was considered to be statistically significant. Iraqi J Pharm Sci, Vol.30(1) 2021 Knowledge and perception towards biosimilars 228 Results The study recruited 264 pharmacists with average age of (30.16 ±6.94 years) and more than half (54.2%) were men. The average years of pharmacists' experience in field of pharmacy were (6.38±6.04 years). Approximately, three-quarters (75.0%) of participants had bachelor’s degree in pharmacy (BSc). Most of them lived in Baghdad (58.7) as shown (Table 1). Table 1. Demographic characteristics of participating pharmacists Item Subcategory Frequency (N) % Gender Female 121 45.8 Male 143 54.2 Degree Bachelor 198 75.0 Diploma 18 6.8 Master 40 15.2 Ph.D. 8 3.0 Province Baghdad 155 58.7 Anbar 28 10.6 Diyala 16 6.1 Karbala 12 4.5 Najaf 11 4.2 others 42 15.9 Item Minimum Maximum Mean Std. Deviation Age 22 68 30.16 6.94 Experience years 0 33 6.38 6.04 When the respondents were asked about the basic information regarding biosimilar medicines, the results showed that two questions received the highest percentages of adequate answers: The requirement of biosimilar medicine for preclinical and clinical studies (58.0%) and the requirement for more comprehensive data compared to generic drugs (56.1%)ˮ . In contrast, the lowest percentage of adequate answers (21.6%) was for question regarding the role of bioequivalence study in marketing authorization of biosimilar medicines (Table 2 and Figure 1). Table 2. Pharmacists’ knowledge about biosimilar medicines Statement Adequate N % 1 «A biosimilar medicine is structurally identical to its reference medicinal product» No 106 40.2 2 «A biosimilar medicine is similar to a reference medicinal product that has gone off-patent» Yes 114 43.2 3 «A biosimilar medicine has no meaningful differences from a reference medicinal product in terms of quality» Yes 117 44.3 4 «A biosimilar medicine has no meaningful differences from a reference medicinal product in terms of safety» Yes 142 53.8 5 «A biosimilar medicine has no meaningful differences from a reference medicinal product in terms of efficacy» Yes 137 51.9 6 «A biosimilar medicine has the same dosage and route of administration compared to its reference medicine» Yes 146 55.3 7 «A biosimilar medicine is a drug for which marketing authorization is granted on the sole investigation of pharmacokinetic bioequivalence with its reference medicine» No 57 21.6 8 «A biosimilar medicine is a drug for which assessment of biosimilarity requires more comprehensive data compared to generic drugs» Yes 148 56.1 9 «A biosimilar medicine requires preclinical and clinical studies» Yes 153 58.0 Iraqi J Pharm Sci, Vol.30(1) 2021 Knowledge and perception towards biosimilars 229 0 1 0 2 0 3 0 4 0 5 0 6 0 B S M h a s t h e s o l e i n v e s t i g a t i o n o f p h a r m a c o k i n e t i c b i o e q u i v a l e n c e . B S M i s s t r u c t u r a l l y i d e n t i c a l t o i t s r e f e r e n c e m e d i c i n e s B S M i s s i m i l a r t o a r e f e r e n c e m e d i c i n a e s B S M h a s n o d i f f e r e n c e s i n q u a l i t y v s r e f e r e n c e . B S M h a s n o d i f f e r e n c e s i n s a f e t y v s r e f e r e n c e . B S M h a s n o d i f f e r e n c e s i n e f f i c a c y v s r e f e r e n c e . B S M h a s t h e s a m e d o s a g e a n d a d m i n i s t r a t i o n r o u t e o f r e f e r e n c e B S M r e q u i r e s m o r e c o m p r e h e n s i v e d a t a c o m p a r e d t o g e n e r i c s . B i o s i m i l a r m e d i c i n e r e q u i r e s p r e c l i n i c a l a n d c l n i c a l s t u d i e s % o f p h a r m a c i s t s w i t h a d e q u a t e a n s w e r s Figure 1. The percentage of pharmacist with correct answers about biosimilar medicines (BSM). The number of participants who adequately answered to the questions about biosimilar medicines is normally distributed. Approximately 41% of the pharmacist answered half of the questions adequately, 60 (22.7%) and 48 (18.2%) participants correctly answered five and four questions respectively. Only 14 (5.3%) had all wrong answers, while eight (3.0%) had all nine correct answers (Table 3). Table 3. Frequency distribution of participants according to number of correct answers with respect to knowledge. Correct answers n % 1 Nine correct answers 8 3.0 2 Eight correct answers 10 3.8 3 Seven correct answers 25 9.5 4 Six correct answers 36 13.6 5 Five correct answers 60 22.7 6 Four correct answers 48 18.2 7 Three correct answers 31 11.7 8 Two correct answers 23 8.7 9 One correct answer 9 3.4 10 No correct answer 14 5.3 The Spearman correlation shows there is significant (P< 0.05) positive correlation between the pharmacist years of experience and total score of the correct answers (Table 4). In other words, longer experience years gives more correct answers. According to the independent samples T-Test, male pharmacists had significantly higher mean of total score of correct answers compared to female pharmacists (Table 5). Table 4. Correlation between the score of adequate answer and pharmacist experience years Correlation Coefficient (r) 0.138 P-value 0.025* N 264 * Correlation is significant at the 0.05 level (2- tailed). Significant positive correlation using Spearman correlation Iraqi J Pharm Sci, Vol.30(1) 2021 Knowledge and perception towards biosimilars 230 Table 5. The difference between the means of accurate answer scores according to gender. Gender N Mean Std. Dev. Mean Difference P-value Total score Female 121 3.926 2.122 -1.025 .0001* Male 143 4.951 1.962 * Significant difference (P-value < 0.05 level). A total of 6 questions were used to investigate pharmacists' perceptions about biosimilar medicines, and the results were outlined in (Table 6). 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 replacing a reference biologic medicines with its biosimilar product by pharmacist. Table 6. Pharmacists’ perceptions about biosimilar medicines Item Strongly disagree N (%) Disagree N (%) Neutral N (%) Agree N (%) Strongly Agree N (%) «I am in favor with the implementation of biosimilar medicines» 24 (9.1) 14 (5.3) 114 (43.2) 90 (34.1) 22 (8.3) «Biosimilar medicines are tried and tested in terms of efficacy and safety» 19 (7.2) 31 (11.7) 44 (16.7) 123 (46.6) 47 (17.8) «Biosimilar medicines are not only pharmacist’s concern» 33 (12.5) 27 (10.2) 50 (18.9) 107 (40.5) 47 (17.8) «I approve a pharmacist substitution of a reference biological medicine to its biosimilar product» 33 (12.5) 54 (20.5) 81 (30.7) 73 (27.7) 33 (12.5) «I approve a pharmacist substitution of a reference medicine product to its generic product» 31 (11.7) 34 (12.9) 79 (29.9) 80 (30.3) 40 (15.2) «Biosimilar medicines prescription allows for reducing healthcare costs» 25 (9.5) 22 (8.3) 47 (17.8) 99 (37.5) 71 (26.9) Discussion The current study provided a snapshot of Iraqi pharmacists’ knowledge, and perceptions about biosimilars. Regarding pharmacists’ knowledge of biosimilars, about half of respondents (52.6%) have answered 5 or more questions (out of 10 questions) correctly. Comparing the results of the current study with that of one French study revealed a significant gap. For example, more than 90% of French pharmacists answered adequately regarding the statements " A biosimilar has no meaningful differences from a reference in terms of quality" and " A biosimilar medicine has no meaningful differences from a reference in terms of efficacy " compared to (44.3%) and (51.9%) in the current study, respectively. All French pharmacist adequate answers for the remaining of the nine questions were more than 70.0% except for the first one " A biosimilar medicine is structurally identical to its reference medicinal product" which was (59.4%). (9) In Europe Union, France is the first country establishing a regulation for biosimilar substitution and creation of a French directory for biosimilars. (10) Although the exact means of biosimilar education were not stated, van Overbeeke et al. suggested a positive relationship between biosimilar education and biosimilar knowledge. (11) The current finding showed that there is a strong need for pharmacist- directed education to enhance knowledge about biosimilars which might increase acceptance of biosimilars as safe and effective therapeutic options. In addition, the current study showed that more experience years associated with better knowledge. When there is little education about biosimilars in the undergraduate study, it is expected that practical experience will be an influential factor. Also, the current study showed that male gender was associated with better knowledge. Possible explanation may be that, compared to female, male Iraqi pharmacists are more involved in drug promotion and marketing where the term " biosimilars" frequently encountered. A total of 6 questions were used to investigate pharmacists' perceptions about biosimilars. Two statements received the highest Iraqi J Pharm Sci, Vol.30(1) 2021 Knowledge and perception towards biosimilars 231 percentage of pharmacist agreements: Biosimilar are tested in terms of efficacy and safety (64.4%) and biosimilar prescription allows for reducing costs (64.4%). Regarding efficacy and safety, various clinical trials gave evidence-based results to confirm that there are no essential differences between a reference biological medicines and their biosimilars in terms of efficacy, and safety. (12, 13) Concerning cost reduction, biosimilars are not only lower in cost to biologic therapies, but also introduce price competition leading to a decrease in the price of reference product. (6) Pharmacist-led biosimilar substitution was another main issues raised in current survey where about 40.0% of pharmacists have approved a pharmacist substitution of a reference biologic medicine to its biosimilar counterpart. This proportion is relatively comparable with the rate of pharmacists who agreed with the substitution of a reference chemical medicines by its generic one (about 45.0%). However; it is lower than that reported in French study where about 53.0% of pharmacists approved pharmacist substitution of a reference biologic medicine to its biosimilar. (9) Iga Pawłowska et al. in their study detected that most Polish pharmacists (about three-quarters) were worried about pharmacist-led substitution and only 23% of pharmacists thought that the reference medicine could be substituted by a biosimilar during therapy (14). In Ireland, Joan Ocallagan et al. found that more than half of Irish pharmacists (58%) were comfortable in changing patients from reference medicine to biosimilars in agreement with the prescriber and only (14%) preferred to make their own decision regarding suitable substitution. (15) Pharmacists must be included in any policy making or regulations concerning biosimilars since they have close contact with both physicians and patients. There are continuous debates about the right of interchangeability, substitution and extrapolation of indications. While the innovative manufacturers are interested to keep their market share large and avoid any competition, biosimilar advocates are more interested in increasing share of biosimilars in the biologic market. Pharmacists are in a good position to keep the balance between the two groups by looking for this issue from the patients’ side to provide biologic products readily accessible and at acceptable prices. (8) Conclusions The majority of the surveyed pharmacists had insufficient knowledge towards biosimilar medicines. The study highlighted that Iraqi pharmacists needed more comprehensive information concerning biosimilar medicines. Limitation of the study The study had some limitations. First, a small sample size of the participants. Hence, the results of the current study cannot be generalized to the whole Iraqi pharmacists. Second, the survey was short and detailed information was not obtained. Nevertheless, the short form of the questionnaire may increase the willingness of pharmacists to complete the survey. Third, the study was cross- sectional done at a particular time point, and the perceptions of pharmacists may change over time. So, it will be valuable to repeat a similar survey several years later to know whether perceptions have changed or not. References 1. Stevenson JG, Popovian R, Jacobs I, Hurst S, Shane LG. Biosimilars: Practical Considerations for Pharmacists. Annals of Pharmacotherapy. 2017;51(7):590-602. 2. Jarrett S, Dingermann T. Biosimilars Are Here: A Hospital Pharmacist’s Guide to Educating Health Care Professionals on Biosimilars. Hosp Pharm. 2015;50(10):884–893. 3. Jeske W, Walenga JM , Hoppensteadt D, Fareed J. Update on the safety and bioequivalence of biosimilars – focus on enoxaparin.Dovepress.2013; (5):133-141. 4. Leonard E, Wascovich M, Oskouei S, Gurz P, Carpenter D. Factors Affecting Health Care Provider Knowledge and Acceptance of Biosimilar Medicines: A Systematic Review. JMCP;25(1):102-112 5. Benefits and Considerations, Biosimilars update: 2019 Report Sixth Edition .Available at :https://www.amgenbiosimilars.com//media/Th emes/Amgen/amgenbiosimilars- com/Amgenbiosimilars-com/pdf/2019-Trends- in-Biosimilars-Report-Electronic-Version--- USA-BIO-80182.pdf .Accessed Augest, 2019. 6. Al Ani N Ab ,Gorial F I, Al-Sulaitti S, Humadi JA, Awadh NI , Mounir M,et al. Review of biologics, biosimilars, and intended copies in rheumatology, and current practice in Iraq.Dovepress.2019;11:1-9. 7. Al-Kinani K.K , Ibrahim MJ, Al-Zubaidi RF , Younus MM, Ramadhan SH, Kadhim JK, et al. Iraqi regulatory authority current system and experience with biosimilars. Regulatory Toxicology and Pharmacology.2020;117:1-5. 8. Kunter İ, Balogun HO, Şahin G. The role of the pharmacist from development to pharmacovigilance of biosimilars. Marmara Pharm. J . 2018; 22(4): 469-473. 9. Beck M, Michel B, Rybarczyk-Vigouret MC, Levêque D, Sordet Ch, Sibilia J, et al. Knowledge, behaviors and practices of community and hospital pharmacists towards biosimilar medicines: Results of a French web- based survey. MAbs .2017;9 (2) :384-391. 10. Adéa A , Bourdon O, Bussières J F. A survey of pharmacists knowledge and views of biosimilars in Quebec and France. Ann Pharm Fr.2017;75(4):267-275. 11. Van Overbeeke E, De Beleyr B, de Hoon J, Westhovens R, Huys I. Perception of originator https://www.amgenbiosimilars.com/media/Themes/Amgen/amgenbiosimilars-com/Amgenbiosimilars-com/pdf/2019-Trends-in-Biosimilars-Report-Electronic-Version---USA-BIO-80182.pdf https://www.amgenbiosimilars.com/media/Themes/Amgen/amgenbiosimilars-com/Amgenbiosimilars-com/pdf/2019-Trends-in-Biosimilars-Report-Electronic-Version---USA-BIO-80182.pdf https://www.amgenbiosimilars.com/media/Themes/Amgen/amgenbiosimilars-com/Amgenbiosimilars-com/pdf/2019-Trends-in-Biosimilars-Report-Electronic-Version---USA-BIO-80182.pdf https://www.amgenbiosimilars.com/media/Themes/Amgen/amgenbiosimilars-com/Amgenbiosimilars-com/pdf/2019-Trends-in-Biosimilars-Report-Electronic-Version---USA-BIO-80182.pdf https://www.amgenbiosimilars.com/media/Themes/Amgen/amgenbiosimilars-com/Amgenbiosimilars-com/pdf/2019-Trends-in-Biosimilars-Report-Electronic-Version---USA-BIO-80182.pdf Iraqi J Pharm Sci, Vol.30(1) 2021 Knowledge and perception towards biosimilars 232 biologics and biosimilars: a survey among Belgian rheumatoid arthritis patients and rheumatologists. BioDrugs. 2017;31(5):447-59. 12. Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, et al. A randomized, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT- P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013; 72(10):1605-12. 13. Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, et al. A randomized, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. AnnRheum Dis 2013; 72(10):1613-20. 14. Pawłowska I, Pawłowski L, Krzyzaniak N, Kocić I . Perspectives of Hospital Pharmacists Towards Biosimilar Medicines: A Survey of Polish Pharmacy Practice in General Hospitals. Bio Drugs. 2019;33(2):183-91. 15. O'Callaghan J, Bermingham M, Leonard M, Hallinan F, Morris M, Moore U, et al. Assessing awareness and attitudes of healthcare professionals on the use of biosimilar medicines: A survey of physicians and pharmacists in Ireland. Regulatory Toxicology and Pharmacology.2017;88:252-261. Baghdad Iraqi Journal Pharmaceutical Sciences by bijps is licensed under a Creative Commons Attribution 4.0 International License. Copyrights© 2015 College of Pharmacy - University of Baghdad. http://bijps.uobaghdad.edu.iq/index.php/bijps.com http://creativecommons.org/licenses/by/4.0/ http://creativecommons.org/licenses/by/4.0/ http://creativecommons.org/licenses/by/4.0/