{"id":586,"date":"2021-06-02T02:15:00","date_gmt":"2021-06-02T02:15:00","guid":{"rendered":"https:\/\/www.pharmascience.com\/?page_id=586"},"modified":"2025-12-03T15:57:26","modified_gmt":"2025-12-03T20:57:26","slug":"generic-drugs-faq","status":"publish","type":"page","link":"https:\/\/pharmascience-02.beauvoir.dev\/en\/generic-drugs-faq\/","title":{"rendered":"Frequently Asked Questions (FAQ)"},"content":{"rendered":"\n\n<section class=\"block block-subpage-header subpage-header bg-primary \" id=\"block_5d5d161ccad14e96c39146e3b08100dd\" data-component=\"block-animation\">\n    <div class=\"container\">\n      <div class=\"row animate\">\n        <div class=\"col-12 block-subpage-header__title-column\">\n\n        \n                  <h1>Frequently Asked Questions (FAQ)<\/h1>\n          \n           \n\n                \n        <\/div>\n      <\/div>\n          <\/div>\n<\/section>\n\n\n\n\n<section class=\"block block-toggles toggles \" id=\"block_5a787b136bda68660e99a8ecca2cdfc7\" data-component=\"block-animation\">\n      <div class=\"container\">\n              <div class=\"row justify-content-end justify-content-lg-around\">\n                        <div class=\"col-12 block-toggles__accordion mt-0 animate animate-fadeInUp\" data-component=\"list-toggle\">\n                                  <div class=\"block-toggles__accordion-item js-toggle-control\" data-control=\"#item-1\">\n                    <button class=\"block-toggles__accordion-header\">\n                      <h4 class=\"\">What Are Generic &#038; Biosimilar Drugs?<\/h4>\n                      <div class=\"block-toggles__accordion-icon\">\n                         <span class=\"block-toggles__accordion-icon--closed\"><svg width=\"20\" height=\"21\" viewBox=\"0 0 20 21\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n<path d=\"M20 12.2967H11.4286V20.8682H8.57143V12.2967H0V9.43959H8.57143V0.868164H11.4286V9.43959H20V12.2967Z\" fill=\"#002856\"\/>\n<\/svg>\n<\/span>\n                         <span class=\"block-toggles__accordion-icon--open\"><svg width=\"20\" height=\"4\" viewBox=\"0 0 20 4\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n<path d=\"M20 3.86816H0V0.868164H20V3.86816Z\" fill=\"#002856\"\/>\n<\/svg>\n<\/span>\n                      <\/div> \n                    <\/button>\n                    <div class=\"block-toggles__accordion-body paragraph js-toggle-controlled\" id=\"item-1\" aria-expanded=\"false\">\n                        <p>A generic drug is an alternative version of a branded drug which contains the same active ingredients, at the same strength, in a formulation that is considered bioequivalent to the original drug. This equivalence is verified by regulatory authorities approving the product at the country level, such as Health Canada, the U.S Foods and Drugs Agency (FDA), or the European Medicines Agency (EMA).<\/p>\n<p>A biosimilar drug is a biologic agent very similar to a branded drug, although not completely identical. Like a generic drug, a biosimilar is intended as an alternative to a branded drug. The safety and efficacy of a biosimilar drug is also approved by regulatory authorities based on clinical trials before it is marketed.<\/p>\n<p>The advantage offered by generic and biosimilar drugs is affordability. The active ingredients of these drugs are no longer patented and can be manufactured and sold by other companies. The price of these drugs is lower than that of branded drugs, making them an attractive option for consumers and payers.<\/p>\n<p>Approved by Health Canada or other country regulators, all generic and biosimilar drugs meet the same rigorous quality standards as the original branded drug.<\/p>\n\n                    <\/div>\n                  <\/div>\n                                  <div class=\"block-toggles__accordion-item js-toggle-control\" data-control=\"#item-2\">\n                    <button class=\"block-toggles__accordion-header\">\n                      <h4 class=\"\">Are Generic and Biosimilar Drugs as Safe and Effective as Original Products?<\/h4>\n                      <div class=\"block-toggles__accordion-icon\">\n                         <span class=\"block-toggles__accordion-icon--closed\"><svg width=\"20\" height=\"21\" viewBox=\"0 0 20 21\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n<path d=\"M20 12.2967H11.4286V20.8682H8.57143V12.2967H0V9.43959H8.57143V0.868164H11.4286V9.43959H20V12.2967Z\" fill=\"#002856\"\/>\n<\/svg>\n<\/span>\n                         <span class=\"block-toggles__accordion-icon--open\"><svg width=\"20\" height=\"4\" viewBox=\"0 0 20 4\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n<path d=\"M20 3.86816H0V0.868164H20V3.86816Z\" fill=\"#002856\"\/>\n<\/svg>\n<\/span>\n                      <\/div> \n                    <\/button>\n                    <div class=\"block-toggles__accordion-body paragraph js-toggle-controlled\" id=\"item-2\" aria-expanded=\"false\">\n                        <p>Yes. Country regulatory authorities are mandated to ensure that generic or biosimilar products offer the same level of safety, efficacity, and purity as original branded medicines. They ensure that this is the case by carefully reviewing the bioequivalence or clinical trials submitted by the generic or biosimilar manufacturer. Approval of the product confirms that safety, efficacy, and purity requirements have been met to the satisfaction of the regulator.<\/p>\n\n                    <\/div>\n                  <\/div>\n                                  <div class=\"block-toggles__accordion-item js-toggle-control\" data-control=\"#item-3\">\n                    <button class=\"block-toggles__accordion-header\">\n                      <h4 class=\"\">Why Are Generic and Biosimilar Drugs Important for Healthcare Systems?<\/h4>\n                      <div class=\"block-toggles__accordion-icon\">\n                         <span class=\"block-toggles__accordion-icon--closed\"><svg width=\"20\" height=\"21\" viewBox=\"0 0 20 21\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n<path d=\"M20 12.2967H11.4286V20.8682H8.57143V12.2967H0V9.43959H8.57143V0.868164H11.4286V9.43959H20V12.2967Z\" fill=\"#002856\"\/>\n<\/svg>\n<\/span>\n                         <span class=\"block-toggles__accordion-icon--open\"><svg width=\"20\" height=\"4\" viewBox=\"0 0 20 4\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n<path d=\"M20 3.86816H0V0.868164H20V3.86816Z\" fill=\"#002856\"\/>\n<\/svg>\n<\/span>\n                      <\/div> \n                    <\/button>\n                    <div class=\"block-toggles__accordion-body paragraph js-toggle-controlled\" id=\"item-3\" aria-expanded=\"false\">\n                        <p>Healthcare systems face increasing strain from factors such as an aging population and the high cost of drug therapies. To ensure the long-term sustainability of health programs, cost effective measures like the use of generic and biosimilar drugs are necessary.<\/p>\n<p>Generic and biosimilar drugs offer safe and effective solutions at a fraction of the cost of the branded original. They can be available at <a href=\"https:\/\/generiquescanadiens.ca\/wp-content\/uploads\/2023\/12\/ACMG_Prix-internationaux-et-medicaments-generiques-prescrits-au-Canada-2023.pdf\" target=\"_blank\" rel=\"noopener\">prices as low as 10%<\/a> of brand. In 2024, 77,7% of prescriptions filled in Canada were with a generic drug.<\/p>\n<p>Generic and biosimilar drugs are essential components of modern health systems, generating savings that can be reinvested to maintain program sustainability, and allow for the continued introduction of new, costly innovative medicines.<\/p>\n\n                    <\/div>\n                  <\/div>\n                                  <div class=\"block-toggles__accordion-item js-toggle-control\" data-control=\"#item-4\">\n                    <button class=\"block-toggles__accordion-header\">\n                      <h4 class=\"\">Who Approves Generics and Biosimilars and How?<\/h4>\n                      <div class=\"block-toggles__accordion-icon\">\n                         <span class=\"block-toggles__accordion-icon--closed\"><svg width=\"20\" height=\"21\" viewBox=\"0 0 20 21\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n<path d=\"M20 12.2967H11.4286V20.8682H8.57143V12.2967H0V9.43959H8.57143V0.868164H11.4286V9.43959H20V12.2967Z\" fill=\"#002856\"\/>\n<\/svg>\n<\/span>\n                         <span class=\"block-toggles__accordion-icon--open\"><svg width=\"20\" height=\"4\" viewBox=\"0 0 20 4\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n<path d=\"M20 3.86816H0V0.868164H20V3.86816Z\" fill=\"#002856\"\/>\n<\/svg>\n<\/span>\n                      <\/div> \n                    <\/button>\n                    <div class=\"block-toggles__accordion-body paragraph js-toggle-controlled\" id=\"item-4\" aria-expanded=\"false\">\n                        <p>Generic and biosimilar drugs must be approved based on their safety, efficacy, purity, and quality by regulatory authorities such as Health Canada, the FDA, or the EMA.<\/p>\n<p>Regulatory submissions for generic drugs are based on evidence of bioequivalence compared to the original branded drug. Complex generics may also require clinical trials. Standards of purity and quality are equivalent or superior to those of the original drug.<\/p>\n<p>Biosimilar drug approval requires evidence from clinical trials that demonstrate the comparable safety, efficacy, purity, and quality of the biosimilar agent to the original biologic drug.<\/p>\n\n                    <\/div>\n                  <\/div>\n                                  <div class=\"block-toggles__accordion-item js-toggle-control\" data-control=\"#item-5\">\n                    <button class=\"block-toggles__accordion-header\">\n                      <h4 class=\"\">What Is Bioequivalence?<\/h4>\n                      <div class=\"block-toggles__accordion-icon\">\n                         <span class=\"block-toggles__accordion-icon--closed\"><svg width=\"20\" height=\"21\" viewBox=\"0 0 20 21\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n<path d=\"M20 12.2967H11.4286V20.8682H8.57143V12.2967H0V9.43959H8.57143V0.868164H11.4286V9.43959H20V12.2967Z\" fill=\"#002856\"\/>\n<\/svg>\n<\/span>\n                         <span class=\"block-toggles__accordion-icon--open\"><svg width=\"20\" height=\"4\" viewBox=\"0 0 20 4\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n<path d=\"M20 3.86816H0V0.868164H20V3.86816Z\" fill=\"#002856\"\/>\n<\/svg>\n<\/span>\n                      <\/div> \n                    <\/button>\n                    <div class=\"block-toggles__accordion-body paragraph js-toggle-controlled\" id=\"item-5\" aria-expanded=\"false\">\n                        <p>Bioequivalence tests are clinical trials aimed at demonstrating that two formulations of a same drug, at the same dosage, are equally safe and effective and can be interchanged. They rest on a direct comparison of the rate at which the original drug and the generic version are absorbed, distributed, and eliminated from the body. If the two formulations are within a narrow range of each other, as defined by regulatory authorities, the two products are deemed to be equivalent.<\/p>\n<p>Bioequivalence is the standard international method for approving generic drugs. It has been relied upon for over 50 years around the world.<\/p>\n\n                    <\/div>\n                  <\/div>\n                                  <div class=\"block-toggles__accordion-item js-toggle-control\" data-control=\"#item-6\">\n                    <button class=\"block-toggles__accordion-header\">\n                      <h4 class=\"\">Do Generic Companies Do R&#038;D?<\/h4>\n                      <div class=\"block-toggles__accordion-icon\">\n                         <span class=\"block-toggles__accordion-icon--closed\"><svg width=\"20\" height=\"21\" viewBox=\"0 0 20 21\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n<path d=\"M20 12.2967H11.4286V20.8682H8.57143V12.2967H0V9.43959H8.57143V0.868164H11.4286V9.43959H20V12.2967Z\" fill=\"#002856\"\/>\n<\/svg>\n<\/span>\n                         <span class=\"block-toggles__accordion-icon--open\"><svg width=\"20\" height=\"4\" viewBox=\"0 0 20 4\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n<path d=\"M20 3.86816H0V0.868164H20V3.86816Z\" fill=\"#002856\"\/>\n<\/svg>\n<\/span>\n                      <\/div> \n                    <\/button>\n                    <div class=\"block-toggles__accordion-body paragraph js-toggle-controlled\" id=\"item-6\" aria-expanded=\"false\">\n                        <p>According to Research Info Source Inc., a specialized Canadian publication, Pharmascience ranks, year-in, year-out, on the list of Canada\u2019s Top 100 Corporate R&amp;D Spenders since 2015. With R&amp;D spending between ~65M$CAD a year, we as a private, Canadian-owned company have made it a strategic priority to invest in R&amp;D. We are proud of our investments in the areas of the formulation of new generics, bioequivalence testing, and clinical research.<br \/>\nAll Pharmascience R&amp;D is conducted domestically and contributes significantly to pharmaceutical innovation, both in Canada and abroad.<\/p>\n\n                    <\/div>\n                  <\/div>\n                              <\/div>\n                    <\/div>\n      <\/div>\n<\/section>\n\n\n\n\n<section class=\"block bg-primary block-text text block-primary-has-separator \" id=\"block_9d12e09c194f836c1baf1208bf3a04ac\" data-component=\"block-animation\">\n  <div class=\"container\">\n    <div class=\"row justify-content-center\">\n      <div class=\"col-12 col-lg-8 col-xl-7 text-center animate animate-fadeInUp\">\n              <div class=\"block-text__section-title\">\n                    <h2 class=\"block-text__title\">Questions for our team?<\/h2>\n        <\/div>\n      <\/div>\n    <\/div>\n    <div class=\"row justify-content-center animate\">\n      <div class=\"col-12 col-md-10 text-center\">\n        <div class=\"block-text__wysiwyg-content text-center\">\n          \n        <\/div>\n\n        <section class=\"links-container\">\n\n          <div class=\"first-link\">\n                                          <a href=\"https:\/\/www.pharmascience.com\/en\/contact\/\" class=\"cta\" >\n                  Contact Us\n                <\/a>\n                \n                      <\/div>\n\n          \n\n            \n        <\/section>\n\n    <\/div>\n  <\/div>\n<\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-586","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ 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