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