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Table 2 Knowledge about biosimilars and their prescription (n = 117)

From: Review and results of a survey about biosimilars prescription and challenges in the Middle East and North Africa region

Questionnaire item N (%) N (%)
Knowledge about biosimilars
 Do you know what biosimilars are?
  Yes 77 (65.8)  
  No 14 (12.0)  
  No answer 26 (22.2)  
 Choose one item that adjusts to your concept of biosmilarsa
  A biologic that demonstrates bioequivalence with the original biodrug and has all preclinical and clinical trials equal to those already performed with the original biodrug. Besides, when approved, it already has a well-defined immunogenicity 48/77 (62.3)  
  A biologic that demonstrates bioequivalence with an original biodrug and does not need clinical trials to be commercialized 12/77 (15.6)  
  A molecule equal to that of the original biologic but of lower production cost 17/77 (22.1)  
  An attempt to copy an innovative biodrug and will never be equal to it 1/77 (1.3)  
  A generic biologic of an already commercialized biodrug 4/77 (5.2)  
Biosimilars’ prescription
 Do you agree with the information that there are already marketed biosimilars in the Arab and Middle Eastern Market?
  Yes 74 (63.2)  
  No 22 (18.8)  
  No answer 21 (17.9)  
 Do you agree with the information that biosimilars are being manufactured in the Arab and Middle Eastern Market?
  Yes 53 (45.3)  
  No 38 (32.5)  
  No answer 26 (22.2)  
 Do you prescribe biosimilars?
  Yes 48 (41.0)  
  No 38 (32.5)  
  No answer 31 (26.5)  
 What are the major drivers that encourage you to prescribe biosimilars?
  Safety 20/48 (41.7)b 40/117 (34.2)c
  Bioefficacy 23/48 (47.9)b 45/117 (38.5)c
  FDA and EMA approval for biosimilar 33/48 (68.8)b 61/117 (52.1)c
  Good manufacturing practices and high reputation of the manufacturer 15/48 (31.3)b 31/117 (26.5)c
  Country of origin of the biosimilars’ manufacturer 14/48 (29.2)b 25/117 (21.4)c
  Lower price of the bioequivalence in comparison with the innovator 31/48 (64.6)b 58/117 (49.6)c
  Nothing encourages you 2/48 (4.2)b 6/117 (5.1)c
 What are the major local drivers that encourage you to prescribe biosimilars?
  Assurance that phase III clinical trials will be performed in a sample of the local population 14/48 (29.2)b 33/117 (28.2)c
  Maintenance of an adequate national system of pharmacovigilance specific to biosimilars 23/48 (47.9)b 36/117 (30.8)c
  Transparency of the local health regulatory authority(ies) 16/48 (33.3)b 34/117 (29.1)c
  Nothing encourages you 7/48 (14.6)b 14/117 (12.0)c
 In your opinion, what are the advantages of a biosimilar?
  Lower price 71/117 (60.7)  
  Commercialization approved with initial indication including all diseases previously approved for the innovative biodrug 32/117 (27.4)  
  Administration route different from that of the original biodrug 10/117 (8.5)  
  Lower therapeutic dose 8/117 (6.8)  
  There are no advantages 6/117 (5.1)  
 Now that biosimilars are coming to the market, you think thatd
  Patient associations should be informed and should be able to give their opinion 28/117 (23.9)  
  Patients should systematically be given information 28/117 (23.9)  
  We should wait for many patients to receive biosimilars in a real life setting before recommending its use in a large population of patients 16/117 (13.7)  
  We should know in which country the drug has been tested/created before using it in your own country 41/117 (35.0)  
Price influence   
 The biosimilar will be less expensive than the reference drug, you think thatd
  These are good news because more patients will be treated with biologics 30/117 (25.6)  
  The cost of a treatment should not come before its effectiveness or safety/tolerance 41/117 (35.0)  
  This will help cost savings 31/117 (26.5)  
  If biosimilars are already in the market, a 30% reduction from the innovator’s price will be sufficient 15/117 (12.8)  
  You do not think that a lower cost will change something 4/117 (3.4)  
Manufacturers’ credibility
 Do you trust a company highly experienced in manufacturing small-molecule generic drugs as a producer of biosimilars knowing that they have the expertise to deal with regulatory authorities and have the knowledge of approval’s guidelines?
  Yes 57 (48.7)  
  No 19 (16.2)  
  No answer 41 (35.0)  
 Do you trust a company with prior experience in manufacturing biologics as a manufacturer of biosimilars?
  Yes 64 (54.7)  
  No 13 (11.1)  
  No answer 40 (34.2)  
  1. aSome people who said no to knowledge also answered this question which is not correct since it says in the questionnaire that only those who said yes in the prior question should answer these questions. Those people who answered but they should have not were not included in this table. For those eligible to answer, they should choose one answer but some of them did more than one question (hence the overall % will exceed 100%)
  2. bAnswers among respondents who answered yes to prescribing biosimilars
  3. cAnswers among all respondents
  4. dParticipants were supposed to pick only one answer but they did not