BIOSIMILARS AND BIOLOGICS in Panama are regulated by Law No. 419 of February 1, 2024, Executive Decree No. 95 of May 14, 2019.   1. Are biosimilar medicines considered the same as generic medicines in your country? No. Generic medicines are defined as medicines distributed or sold that are marked with the generic name of…

Are biosimilar medicines considered the same as generic medicines in your country? In Egypt, Biosimilars are considered different from Generic Medicines but similar to biological products, where the “Biosimilar” definition according to the Guidelines for Registration of biosimilar products in Egypt, is the following: A similar biological medicinal product having the same active substances, dosage…

1. Are biosimilar medicines considered the same as generic medicines in your country? No, biosimilar medicines are not considered the same as generic medicines in Iraq. Generic medicines are chemically identical to their branded counterparts, while biosimilars are derived from living organisms and are similar but not identical to the original biologic product.   2.…

1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are not considered the same as generic medicines. According to the Health Sciences Authority of Singapore (“HSA”), biologics are medicinal products with large complex molecules produced by living cells through highly specific processes. Even a slight change in the manufacturing…

Key legal info on biosimilars & biologics in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar drugs are not the…

Key legal info on biosimilars & biologics in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GB 119.   1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are not…

Key legal info on biosimilars & biologics in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.   1. Are biosimilar medicines considered the same as generic medicines in your country? No,…

The ins and outs of biosimilars & biologics in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119.   1. Are biosimilar medicines considered the same as generic medicines in your country? No, they are…

An insight into biosimilars & biologics in Indian Pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 119.   1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar…

The key facts about biosimilars and biologics in Chile. Prepared in association with Carey, a leading global law firm, this is an extract from The Pharma Legal Handbook: Chile, available to purchase here for GBP 99.   1. Are biosimilar medicines considered the same as generic medicines in your country? No. According to Technical Guideline…