17/09/2021
The key facts about biosimilars and biologics in Colombia. Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? No, generic medicines are understood as medicines with the same structure of the active substance as the reference medicine. And biosimilar medicines are those biotech molecules that can have a…
08/09/2021
Key legal info on biosimilars & biologics in Portugal. Prepared in association with Cuatrecasas, a leading Iberian law firm, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for GBP 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are defined by exclusion, i.e. a biosimilar medicine is a biological medicine which does not fulfil the conditions of the definition of a generic medicine (amongst other,…
30/08/2021
Key legal info on biosimilars & biologics in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? The basic principles of research and evaluation of biosimilar medicines are similar to that of generic medicines, but the regulation in practice is different. Biosimilar medicines are…
29/07/2021
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 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? No, biosimilars are not regarded as generics of biological medicines. Czech legislation implements EU directives, and directly applicable EU regulations on biosimilars and biologics apply. EU…
15/07/2021
Key legal info on biosimilars & biologics in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for GBP 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? No, compared to generics with chemically synthesized active ingredients, the production of biosimilars is much more complex, and further requirements must be met for their approval. …
10/07/2021
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 same as generic drugs in Russia. A biosimilar drug cannot be a copy of the original biological drug, as in respect of a biosimilar drug…
13/05/2021
Key facts about biosimilars and biologics in Mexico. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? No, biosimilars are not considered the same as generic medicines. Biosimilars are regulated by specific provisions within the sanitary legislation. The Mexican General Health Law defines a “biologic product” as any substance…
29/04/2021
All legal aspects surrounding localization in Bulgaria. Prepared in association with Kinstellar and PharmDedict, this is an extract from The Pharma Legal Handbook: Bulgaria, available to purchase here for GBP 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? In order to be considered generic biosimilar medicines shall fulfill the requirements for categorizing a product as generic, namely: Generic medicinal product shall be a medicinal product of the same qualitative and quantitative composition in terms…
28/04/2021
The key facts about biosimilars and biologics in Japan. Prepared in association with Nishimura & Asahi, a leading law firm in Japan, this is an extract from The Pharma Legal Handbook: Japan, available to purchase here for GBP 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? A biosimilar medicine is differentiated from a generic medicine in the point that final biosimilar products possibly differ from the original product, depending on the manufacturing process. This…
20/04/2021
All legal aspects surrounding biosimilars and biologics in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? Under the Pharmaceutical Law, a product is deemed as generic with respect to the reference product if it has the same qualitative and quantitative composition of…
15/04/2021
The ins and outs of biosimilars and biologics in Romania. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? The biosimilar medicinal products are not considered the same as generic medicinal products, since the Romanian legislation regulates in a different manner biosimilars and generics. As per the local…
12/04/2021
The legal framework for biosimilars and biologics in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are not considered the same as generic medicines in Slovakia. A similar biological medicinal product, also known as “biosimilar”, is a product which is similar (not identical)…
27/06/2020
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 No. 170, issued by the Ministry of Health on August 21, 2014 and approved by decree No. 945 of 2014 -and its amendments-, which contain…
26/05/2020
A brief overview of the situation regarding biosimilars & biologics in Singaporean Pharma. Prepared in association with Drew & Napier LLC, this is an extract from The Pharma Legal Handbook: Singapore, available to purchase here for USD 99. 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…
14/03/2020
Biosimilars & biologics in Brazil – a comprehensive legal overview. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 75, here. 1. Are biosimilar medicines considered the same as generic medicines in your country? No, a biosimilar drug is not considered to be the same as a generic drug. There are specific rules governing generic and similar drugs, and they…
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 GBP 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are not the same as generic drugs (a drug that contains the same molecule as an existing non-biological medicine, such as aspirin). Namely, biological medicine, unlike non-biological…
13/03/2020
All legal aspects surrounding biosimilars & biologics in Argentina. Prepared in association with Marval, O’Farrell & Mairal, a leading global law firm, this is an extract from The Pharma Legal Handbook: Argentina, available to purchase here for GBP 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? No, biosimilar medicines have their own legal regime. ANMAT does not use any specific term such as “biosimilar” or “biocomparable”, but defines this type of biological medicines as: “medicinal…
31/01/2020
The low-down on the situation regarding biosimilars & biologics in Turkey. Prepared in association with Moroğlu Arseven, a leading Turkish law firm, this is an extract from The Pharma Legal Handbook: Turkey, available to purchase here for GBP 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? Generic medicines include identical molecules with the original reference product, and these molecules are small and chemically stable molecules produced through chemical synthesis. However, biosimilar is the name…
23/01/2020
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 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? No, they are different. On one side biosimilar products are biologically synthesized products which require a much more complex procedure to elaborate due to the fact that bigger…
The key facts about biosimilars & biologics in Panamanian Pharma. Prepared in association with AFRA, a leading global law firm, this is an extract from The Pharma Legal Handbook: Panama, available to purchase here for GBP 75. BIOSIMILARS AND BIOLOGICS in Panama are regulated by Law 1 January 10, 2001, 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…
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 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are not regulated in the same manner as generic medicines in India. While biosimilars and generic medicines are classified as drugs under the Drugs…
Biosimilars & biologics in Egypt – a legal guide. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75. 1. 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…
Key legal info on biosimilars & biologics in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? No. A biosimilar medicinal product is a new version of an existing biological medicinal product (i.e. a medicinal product is derived from a biological source). Biosimilar products are…
20/01/2020
A brief overview of the situation regarding biosimilars and biologics. Prepared in association with SAARPE Association, a leading law firm in Algeria, this is an extract from The Pharma Legal Handbook: Algeria, available to purchase here for USD 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? The Health Law No 18-11, dated of 2 July 2018 and published in the Official Gazette, has made a clear distinction between similar biotherapeutic products and generic…
11/11/2019
Biosimilars and biologics in Thailand – a legal guide. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? No. At present, a “biosimilar” is not the same as a generic drug. Previously, some biological marketing authorization licenses were obtained by using the same registration pathway of generic…
08/09/2019
Biosimilars and biologics in Ecuadorian pharma – a comprehensive legal overview. Prepared in association with Corral Rosales, a leading global law firm, this is an extract from The Pharma Legal Handbook: Ecuador, available to purchase here for GBP 75. 1. Are biosimilar medicines considered the same as generic medicines in your country? No, the generic term is used only for chemical synthesis medicines and the term biosimilar is used for medicines of biological origin. The biosimilar medicine is similar…
05/09/2019
Biosimilars and biologics in Canada: A legal guide. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99. 1. Are biosimilar medicines considered the same as generic medicines in your country? A biosimilar is not a generic biologic product since it is not identical to its reference product; its authorization does not constitute evidence of pharmaceutical equivalence, bioequivalence or clinical equivalence. A biosimilar is a…
08/10/2019
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