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M 10: Factors That Affect Market Share of Biosimilars Against Reference Biologics
Christopher G. Milan
Pharmacy Student, Phi Lambda Sigma Chapter President
Touro College of Pharmacy United States
The objective of this study to evaluate existing and possible new factors of the current healthcare system and pharmacoeconomics landscape for analyzing market share outlook of biosimilars among pharmaceutical companies, in relation to the innovator biologic products.
For this study, we reviewed literature of biosimilars and the respective reference biologic product in the current global drug market. The outlook and drugs were assessed by product makeup, therapeutic classes and indications, healthcare expenditures, regulatory status, and geographical location.
The biosimilars landscape is focused on recombinant non-glycosylated proteins (filgrastim, insulin, interferons), glycosylated proteins (erythropoietin, monoclonal antibodies, and peptides (calcitonin, glucagon); the application of these agents and their reference biologics are mostly used and applied in oncology and blood disorders. In the European market, Granulocyte-colony stimulating factor (G-CSFs) had an increase of biosimilar market share from 1% in 2008 to 60% in 2013 against the reference biologic product. Erythropoietin-stimulating agents (ESAs) increased from 3% in 2008 to 25% in 2013 against the reference biologic product. In the US, the first biosimilar was only approved in March 2015, with many products in pipeline from a multitude of market players. Biosimilars is projected to account for 4-10% of the biologics market total by 2020, which is dependent on regulatory approval. The growing demand of biosimilars to decrease healthcare expenditures is being fueled by expiring brand patents, reducing patient out-of-pocket costs, increasing alternative, interchangeable drug regimens and therapeutic cost-effectiveness. With the rising incidences of various diseases like rheumatoid arthritis, blood disorders, and numerous cancers, statistically and clinically significant outcomes in ongoing clinical trials of biosimilars in comparison to placebo is to be noted. Factors affecting a decrease in market share of biosimilars include drug complexities, expensive manufacturing costs, and strict regulatory approvals and processes. Biologic reference products have not always been priced above biosimilars. Between 2005 and 2013, the level of price erosion has been gradual for epoetin alfa, epoeitin beta, filgrastim, and lenograstim, in comparison to the respective biosimilars. The global biosimilars market is expected to increase to $6.22 billion by 2020, with a compound annual growth rate (CAGR) of 22.1% from 2015 to 2020.
The emergence and innovative implementation of biosimilars in relation to pharmacoeconomics will affect the market share of existing drug products. New research and business development endeavors, approval pathways and dispensing legislations, treatment alternatives, patient safety and effectiveness monitoring/guidelines, costs and reimbursements are all factors in the biosimilars market against reference biologics. While patent drugs are expiring, biosimilars approval and alternative use will decrease payer costs, which affects therapeutic cost-effectiveness. Neither a generic nor a novelty brand drug, biosimilars are gaining increasing use and affecting healthcare systems and healthcare economics worldwide. The application of biosimilars in diseases like cancer, diabetes, rheumatoid arthritis, multiple sclerosis, and other serious conditions motivates more biosimilars to be implemented in the market, especially when the agents provide a cheaper, effective and safe alternative. However, pharmaceutical companies are faced with drug complexities, expensive manufacturing costs, and strict regulatory approvals and processes, which can hinder market share outlooks when comparing biosimilars to reference biologic products. Therefore, expansions of pharmaceutical companies such as partnerships, joint ventures, and agreements have strengthened market players and their portfolios. Many countries in Europe have already approved biosimilars and they are currently dominating the global biosimilars market; the US and the Asia-Pacific will soon experience more biosimilar products. This is due to the developing infrastructure of healthcare, increasing patient population, and growing investments and funding for the advancement of biosimilars. Biosimilars will affect our lives, and the lives of our patients both in the short- and long-term. The worldwide healthcare system and pharmacoeconomics will continue to adapt as different biosimilars become available.