Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Biosimilars in the EU and the USA: Impact of regulations on the development, registration and marketing process and consequences from the reimbursement system in Germany
Elwira Baldyga (Abschlußjahr: 2012)
Language: English
This master thesis has the aim to highlight and analyze especially the difficulties and opportunities in the market access process of cost intensive development of a biosimilar, having regard to the recent development in the German reimbursement system. The main focus of description of reimbursement system is laid down on Germany, because in the EU e.g. Germany several Biosimilars are since 2006 on the market, thus first experience of the reimbursement and prescription situation can be analyzed.
The established regulatory pathway for biosimilars in the US will be compared to the existing regulatory pathway in the EU. The European regulatory bodies were pioneers in terms of regulatory pathway for biosimilars within the highly regulated markets. Since 2006 almost 14 Biosimilars were approved by the EMA and several Guidelines issued. In 2010 the government under President Barack Obama established a regulatory pathway for Biosimilar applications. 2012 first draft guidelines were issued by the FDA.
The hurdles and opportunities to harmonize the development for the EU and the USA will be described in this master thesis. In particular the current reimbursement situation for existing Biosimilars on the German market is highlighted and the attitude towards interchangeability between the Biosimilars within the existing legal framework set by the ministry of health and the relevant stake holders in Germany. An outlook for the USA is as well given based on the recent regulatory development. As there are no approved biosimilars through the recent established regulatory pathway in the USA yet, there is a lack of experience with marketing of biosimilars in the USA.
The established regulatory pathway for biosimilars in the US will be compared to the existing regulatory pathway in the EU. The European regulatory bodies were pioneers in terms of regulatory pathway for biosimilars within the highly regulated markets. Since 2006 almost 14 Biosimilars were approved by the EMA and several Guidelines issued. In 2010 the government under President Barack Obama established a regulatory pathway for Biosimilar applications. 2012 first draft guidelines were issued by the FDA.
The hurdles and opportunities to harmonize the development for the EU and the USA will be described in this master thesis. In particular the current reimbursement situation for existing Biosimilars on the German market is highlighted and the attitude towards interchangeability between the Biosimilars within the existing legal framework set by the ministry of health and the relevant stake holders in Germany. An outlook for the USA is as well given based on the recent regulatory development. As there are no approved biosimilars through the recent established regulatory pathway in the USA yet, there is a lack of experience with marketing of biosimilars in the USA.
The regulatory bodies have to set the necessary regulatory frame in terms of drug efficacy and safety for biosimilars. In the EU the interchangeability between biosimilars is handled on a national level. Especially in Germany the relevant stake holders in the health insurance system will play a significant role during the marketing phase of biosimilars, whereas the FDA uses already the term interchangeability in their draft regulatory guidelines for regulatory approval. Up to day it is a question mark based on which regulatory requirements the FDA will asses the interchangeability in the USA.
The acceptance by health professionals, patients, paying bodies and prescribing physicians will play a significant role during the marketing phase of biosimilars. Only in case there will be enough safety in terms of interchangeability of a biosimilar product prescribing physicians will choose this opportunity.
Pages: 54
The acceptance by health professionals, patients, paying bodies and prescribing physicians will play a significant role during the marketing phase of biosimilars. Only in case there will be enough safety in terms of interchangeability of a biosimilar product prescribing physicians will choose this opportunity.
Pages: 54