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