Growth Potential of Biosimilar Products in Bangladesh

Abstract

In view of the global changes in disease pattern, reduced health budget in developed countries, increasing health budget in developing countries, patent expiry of some high valued products, transformations in R&D productivities and side effects of chemical drugs global pharmaceutical giants are concentrating on biologic products among which anticancer, antidiabetic, antiarthritic, cardiovascular products are especially important. However, developing a biotech product involved huge cost which is possible only by research based top companies. Realizing the fact, many pharmaceutical companies tried to imitate the original biotech products after patent expiry and became successful which bring a breakthrough in terms of health cost. These imitated products are termed as biosimilar products. Although the history of biosimilars started at European Union (EU) in 2006 with single product but currently it has been recognized everywhere in the world and EU have highest 19 biosimilar products. United States Food & Drug Administration (USFDA) was little conservative with biosimilars; nevertheless, they approved the first biosimilar 09 years after EU approval and presently they have three biosimilars which are playing significant role in price cutting of branded biologics. They also have so many biosimilars in pipelines. Emerging economies especially South Africa, China & India are very aggressive with biosimilars. Under Pharmaceutical Benefits Scheme Australian government is promoting biosimilars and they already approved 09 biosimilars. Japan, Korea, Canada are also encouraging biosimilars. Bangladesh isthe only Least Development Countries (LDCs) that have very strong pharmaceutical sector; there are so many manufacturing facilities with global standard and approved by USFDA and UKMHRA. Bangladesh pharmaceuticals industry worth $ 2 billion and have a long history success in both domestic and international markets with generic products. Unlike global giants very few Bangladeshi companies are putting concentration on biosimilars. Till to date one pharmaceutical claimed them as true biosimilar company without any product in the market. 08 other pharmaceutical companies are offering Non-Comparable Biologics (NCBs) which is below 5% of the total domestic revenue although biologics accounts for more than 22% of the global total. Considering huge number of patients with chronic diseases, increasing access to biologic treatment due to changes in income level, improving access to medical services and diagnostic facilities, easy regulations, cheap labor and related cost factors, geographical location, availability of trainable manpower, raising patient awareness, price sensitivity, strong entrepreneurial skills Bangladesh is in little advantageous position with biosimilars. However, success of biosimilars in Bangladesh is mostly depends on the acceptance by the physicians, reduction of treatment cost, increasing life expectancy, easy availability at the drug stores, trust on manufacturers, various promotional and disease awareness campaigns, dissemination of proper information towards doctors and patients, monitoring by the regulatory bodies, government patronization, drug substitution, efficacy and safety of the individual product, technical collaboration with the experts, export possibilities etc. Therefore, this study identifies the growth potential of biosimilar products in Bangladesh.