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Biosimilars : a new generation of biologics / / Jean-Louis Prugnaud, Jean-Hugues Trouvin, editors ; [translated by Mrs. Laurence Grenier]
| Biosimilars : a new generation of biologics / / Jean-Louis Prugnaud, Jean-Hugues Trouvin, editors ; [translated by Mrs. Laurence Grenier] |
| Pubbl/distr/stampa | Paris, : Springer, 2013 |
| Descrizione fisica | 1 online resource (100 p.) |
| Disciplina |
610.28
615.7 |
| Altri autori (Persone) |
PrugnaudJean-Louis
TrouvinJean-Hugues GrenierLaurence, Mrs. |
| Soggetto topico |
Generic drugs - European Union countries
Pharmaceutical biotechnology - European Union countries Patent medicines - European Union countries |
| ISBN |
1-283-91060-8
2-8178-0336-1 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Preface: Biosimilars – a philosophy? -- Foreword -- 1. Biosimilars characteristics -- Introduction : from generics to biosimilars -- Definitions -- Complexity of biologics and examples -- Conclusion -- 2. From the biosimilar concept to the Marketing Approval. –Introduction -- Definition of biosimilars -- Pharmaceutical approval’s framework -- Quality control approach -- Non clinical and clinical aspects -- Recommendations in onco-hematology -- Other recommendations -- Conclusion -- 3. Immunogenicity -- Introduction -- Immune mechanisms -- Usual immune response -- Immunologic tolerance breakdown response -- Factors influencing immunogenicity -- Case of monoclonal antibodies -- Conclusion -- 4. Substitution and interchangeability -- Introduction -- Generics and biosimilars’ substitution -- What about biosimilar medicinal products ? -- Interchangeability: suggested definition -- Biosimilars’ interchangeability and conditions to be implemented -- Interchangeability practices -- Conclusion -- 5. Onco-hematologist point of view –GCSFcase -- Biosimilars -- Conclusion -- 6. The oncologist‘s point of view -- Introduction -- Erythropoiesis-stimulating Agents (ESA) -- Biosimilars -- Conclusion -- 7. Challenges posed by biosimilars: who is responsible for cost and risk management -- Introduction -- General information on cost management -- Savings linked to the purchase of biosimilars -- General information on risk management responsibility -- Conclusion. |
| Record Nr. | UNINA-9910438011403321 |
| Paris, : Springer, 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Intellectual property related generic defense strategies in the European pharmaceutical market : implications of the EU Commission's sector inquiry from an IP, competition law and economic perspective / / Marc P. Philipp
| Intellectual property related generic defense strategies in the European pharmaceutical market : implications of the EU Commission's sector inquiry from an IP, competition law and economic perspective / / Marc P. Philipp |
| Autore | Philipp Marc P |
| Pubbl/distr/stampa | Nomos Verlagsgesellschaft mbH & Co. KG, 2011 |
| Descrizione fisica | 1 electronic resource (92 p.) |
| Collana | MIPLC studies |
| Soggetto topico |
Drugs - Law and legislation - European Union countries
Drugs Generic drugs - European Union countries Antitrust law - European Union countries |
| Soggetto non controllato |
Wettbewerbsrecht
Handels- und Wirtschaftsrecht Kartellrecht |
| ISBN | 3-8452-3103-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction -- Governance framework of Europe's pharmaceutical sector -- Competitive dynamics in Europe's pharmaceutical market -- Potential future limitations for generic defense -- Implications of business model transformations -- Conclusion & managerial recommendation. |
| Altri titoli varianti | Intellectual Property Related Generic Defense Strategies in the European Pharmaceutical Market |
| Record Nr. | UNINA-9910297035003321 |
Philipp Marc P
|
||
| Nomos Verlagsgesellschaft mbH & Co. KG, 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Intellectual property related generic defense strategies in the European pharmaceutical market : implications of the EU Commission's sector inquiry from an IP, competition law and economic perspective / / Marc P. Philipp
| Intellectual property related generic defense strategies in the European pharmaceutical market : implications of the EU Commission's sector inquiry from an IP, competition law and economic perspective / / Marc P. Philipp |
| Autore | Philipp Marc P |
| Pubbl/distr/stampa | Nomos Verlagsgesellschaft mbH & Co. KG, 2011 |
| Descrizione fisica | 1 electronic resource (92 p.) |
| Collana | MIPLC studies |
| Soggetto topico |
Drugs - Law and legislation - European Union countries
Drugs Generic drugs - European Union countries Antitrust law - European Union countries |
| Soggetto non controllato |
Wettbewerbsrecht
Handels- und Wirtschaftsrecht Kartellrecht |
| ISBN | 3-8452-3103-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction -- Governance framework of Europe's pharmaceutical sector -- Competitive dynamics in Europe's pharmaceutical market -- Potential future limitations for generic defense -- Implications of business model transformations -- Conclusion & managerial recommendation. |
| Altri titoli varianti | Intellectual Property Related Generic Defense Strategies in the European Pharmaceutical Market |
| Record Nr. | UNISA-996344234403316 |
|
Philipp Marc P
|
||
| Nomos Verlagsgesellschaft mbH & Co. KG, 2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
| ||
