Background: Only drafts of regulatory guidelines for the registration of biosimilars are available in Lebanon. We\nanalyzed the results of a regional survey conducted in Lebanon to understand the impact of different parameters on\nthe acceptance and future prescription of biosimilars. We also reviewed the current situation of biosimilars around the\nworld. The study surveyed healthcare professionals from the Arab countries, Iran, Belgium and Italy. Data about the\nparticipants� specialty, country of residence, their knowledge about biosimilars, biosimilars� prescription, price influence\nand the manufacturer�s credibility were collected.\nResults: 117 questionnaires were completed and returned: 46 (39.3%) respondents were oncologists. 72 (61.5%)\nrespondents were Lebanese, and the others from Egypt, Syria, Algeria, Iraq, Sudan, Jordan, Iran, Belgium and Italy.\n77 (65.8%) respondents had knowledge about biosimilars, of whom 48 (62.3%) considered biosimilars as biologics\nthat demonstrate bioequivalence with the original biodrug and have all preclinical and clinical trials equal to those\nalready performed with the original biodrug. 74 (63.2%) out of 117 respondents agreed that biosimilars in the Arab\nand Middle Eastern market are already marketed. Among the 48 participants who prescribe biosimilars, the main\nprescription driver was the drug�s approval by the FDA and EMA (68.8%). 71 (60.7%) respondents considered that the\nmain advantage of biosimilars is their lower price and 41 (35%) out of the 117 respondents declared that they should\nknow in which country the drug has been tested/created before using it in their own country. 35% of the respondents\nthought that the cost of a treatment should not come before its effectiveness or safety/tolerance, given that the\nbiosimilar will be less expensive than the reference drug.\nConclusions: Biosimilars� acceptance and use is increasing worldwide. Only few physicians are aware of biosimilars\npresence in the market and do prescribe them in Lebanon and the Arab region. This could be mainly explained by\nlack of confidence in efficacy, safety, manufacturing process and price of these products, and lack of clear legislation.\nThus, WHO is finalizing a new guideline for similar biotherapeutic agents. This could be a starting point for the Lebanese\ngovernment to support the authorization of biosimilars.
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