“…Therefore, producing biosimilars to serve as the “biosimilar” versions of biologics would help in saving billions of dollars annually. These savings are projected to reach around 9 to 12 billion USD for the U.S. Medicare program during the next decade . Although biologics are highly effective, their cost is a burden on the health care sector and end‐consumer.…”
Section: Resultsmentioning
confidence: 99%
“…A wide range of products fall under the category of "biologics" [1]. Such products have become part of the standard of care in treatment of a large variety of diseases, such as cancer, cardiovascular illnesses, hemophilia, autoimmune diseases such as multiple sclerosis and rheumatoid arthritis, and rare genetic conditions such as Gaucher's disease and Fabry disease [1,11]. Biosimilars are prescribed in four important therapeutic areas, namely, erythropoietin (EPO) for anemia in patients on renal dialysis, granulocyte colony-stimulating factor (G-CSF) for lowered white blood cell counts after chemotherapy, HGH, FSH for reproduction, and monoclonal antibodies in rheumatology [6,12,13].…”
Section: Definitionsmentioning
confidence: 99%
“…Biosimilars contain different inactive ingredients and may have different brand names, appearance, and packaging from the reference medicinal product [11]. Several expressions have been used in the U.S., the European Union (EU), Canada, and other countries to refer to biosimilars, including follow-on biologics, follow-on protein products, biogenerics, and generic biologics [1,17]. In the U.S., the Biologics Price Competition and Innovation Act defines biosimilar as "a biological product highly similar to the reference product notwithstanding minor differences in clinically inactive components;" and with "no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity, and potency of the product" [18].…”
This article highlights the importance of biosimilars, as a cost-cutting strategy, in the delivery of state-of-the-art health care in developing countries, at a fraction of what a reference biological agent would cost.
“…Therefore, producing biosimilars to serve as the “biosimilar” versions of biologics would help in saving billions of dollars annually. These savings are projected to reach around 9 to 12 billion USD for the U.S. Medicare program during the next decade . Although biologics are highly effective, their cost is a burden on the health care sector and end‐consumer.…”
Section: Resultsmentioning
confidence: 99%
“…A wide range of products fall under the category of "biologics" [1]. Such products have become part of the standard of care in treatment of a large variety of diseases, such as cancer, cardiovascular illnesses, hemophilia, autoimmune diseases such as multiple sclerosis and rheumatoid arthritis, and rare genetic conditions such as Gaucher's disease and Fabry disease [1,11]. Biosimilars are prescribed in four important therapeutic areas, namely, erythropoietin (EPO) for anemia in patients on renal dialysis, granulocyte colony-stimulating factor (G-CSF) for lowered white blood cell counts after chemotherapy, HGH, FSH for reproduction, and monoclonal antibodies in rheumatology [6,12,13].…”
Section: Definitionsmentioning
confidence: 99%
“…Biosimilars contain different inactive ingredients and may have different brand names, appearance, and packaging from the reference medicinal product [11]. Several expressions have been used in the U.S., the European Union (EU), Canada, and other countries to refer to biosimilars, including follow-on biologics, follow-on protein products, biogenerics, and generic biologics [1,17]. In the U.S., the Biologics Price Competition and Innovation Act defines biosimilar as "a biological product highly similar to the reference product notwithstanding minor differences in clinically inactive components;" and with "no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity, and potency of the product" [18].…”
This article highlights the importance of biosimilars, as a cost-cutting strategy, in the delivery of state-of-the-art health care in developing countries, at a fraction of what a reference biological agent would cost.
“…Biosimilars are medicinal products with a similar but not identical safety, efficacy and quality as the authorized reference (originator) biologic agents. They are composed of an analogous active substance but are large molecular-weight, complex molecules that are produced in living cells through genetic engineering (Sylvester et al 2013). They are also referred to as biological and biotherapeutic agents/products.…”
BackgroundOnly drafts of regulatory guidelines for the registration of biosimilars are available in Lebanon. We analyzed the results of a regional survey conducted in Lebanon to understand the impact of different parameters on the acceptance and future prescription of biosimilars. We also reviewed the current situation of biosimilars around the world. The study surveyed healthcare professionals from the Arab countries, Iran, Belgium and Italy. Data about the participants’ specialty, country of residence, their knowledge about biosimilars, biosimilars’ prescription, price influence and the manufacturer’s credibility were collected.Results117 questionnaires were completed and returned: 46 (39.3%) respondents were oncologists. 72 (61.5%) respondents were Lebanese, and the others from Egypt, Syria, Algeria, Iraq, Sudan, Jordan, Iran, Belgium and Italy. 77 (65.8%) respondents had knowledge about biosimilars, of whom 48 (62.3%) considered biosimilars as biologics that demonstrate bioequivalence with the original biodrug and have all preclinical and clinical trials equal to those already performed with the original biodrug. 74 (63.2%) out of 117 respondents agreed that biosimilars in the Arab and Middle Eastern market are already marketed. Among the 48 participants who prescribe biosimilars, the main prescription driver was the drug’s approval by the FDA and EMA (68.8%). 71 (60.7%) respondents considered that the main advantage of biosimilars is their lower price and 41 (35%) out of the 117 respondents declared that they should know in which country the drug has been tested/created before using it in their own country. 35% of the respondents thought that the cost of a treatment should not come before its effectiveness or safety/tolerance, given that the biosimilar will be less expensive than the reference drug.ConclusionsBiosimilars’ acceptance and use is increasing worldwide. Only few physicians are aware of biosimilars presence in the market and do prescribe them in Lebanon and the Arab region. This could be mainly explained by lack of confidence in efficacy, safety, manufacturing process and price of these products, and lack of clear legislation. Thus, WHO is finalizing a new guideline for similar biotherapeutic agents. This could be a starting point for the Lebanese government to support the authorization of biosimilars.Electronic supplementary materialThe online version of this article (doi:10.1186/s40064-016-3779-8) contains supplementary material, which is available to authorized users.
“…Разом з тим, шляхом звичайного синтезу подібного лікарського засобу не можна було створити подібний біотехнологічний продукт. Тому за допомогою сучасних технологій при бажанні відтворити біотехнологічний продукт отримують біосиміляр [6].…”
Національний медичний університет імені О. О. Богомольця, Київ, Україна gorchakovan@ukr.net Гуманітарні питання медицини і проблеми викладання у вищій школі Український журнал медицини, біології та спорту -Том 4, № 4 (20)
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