Biosimilars

A literature review was conducted with the expression “Biosimilars”, in English and in French:
– between the 11 and 13 July 2022, and
– between the 21 and 28 November 2022
in the following databases: Dalloz, HeinOnline, Lexbase, Lexis Nexis, Lextenso, Navis, Doctrinal Plus, Westlaw UK, Brill, Cairn, Bibliothèque numérique en droit de la santé, Wiley Online Library, Lamyline Reflex, Cambridge University Press Revues – Archives ISTEX, De Gruyter revues – Archives ISTEX, Encyclopédie Max Planck de droit international public, JSTOR, Law Review Commons, OpenEdition Journals, ScienceDirect, Springer Nature, Web of Science, Google Scholar and PubMed.
Please find below the most relevant results of this review.

Agostini, Carlo, Canonica, Giorgio Walter, and Maggi, Enrico. « European Medicines Agency Guideline for Biological Medicinal Products: A Further Step for a Safe Use of Biosimilars ». Clinical and Molecular Allergy 13, n^o 1 (15 May 2015): 3. https://doi.org/10.1186/s12948-015-0010-3.

Allocati, Eleonora, Bertele’, Vittorio, Gerardi, Chiara, Garattini, Silvio, and Banzi, Rita. « Clinical Evidence Supporting the Marketing Authorization of Biosimilars in Europe ». European Journal of Clinical Pharmacology 76, n^o 4 (1^st  April 2020): 557‑566.
https://doi.org/10.1007/s00228-019-02805-y.

Averbuch, Ariel, and Graeser, D’vorah. « The Future of Biosimilars. » Intellectual Property Magazine, February 2012, 45‑46.

Banthia, Vinita. « Biosimilars: Countering Shortages of Biotherapies in a Global and Local Context ». IDEA: The Journal of the Franklin Pierce Center for Intellectual Property 57, n^o 3 (2017 2016): 359‑384.

Barbier, Liese, Mbuaki, Allary, Simoens, Steven, Declerck, Paul, Vulto, Arnold G., and Huys, Isabelle. « Regulatory Information and Guidance on Biosimilars and Their Use Across Europe: A Call for Strengthened One Voice Messaging ». Frontiers in Medicine (9 March 2022): Published online.
https://doi.org/10.3389/fmed.2022.820755.

Becker, Rainer, et Papadopoulou, Maria Olga. « Application du droit européen de la concurrence au secteur pharmaceutique : défis, enjeux et perspectives ». Revue Lamy de la concurrence, n^o 116 (1^st May 2022).

Blackstone, Erwin A., and Fuhr, Joseph P. Jr.. « The Future of Competition in the Biologics Market ». Temple Journal of Science, Technology and Environmental Law 31, n^o 1 (2012): 1‑30.

Bocquet, François. « Entre difficultés de statuer sur la question de substitution et incitations financières à leur prescription : quelle régulation optimale pour les médicaments biosimilaires ? » Revue générale de droit médical 7, n^o 28 (January 2020): 227‑244.

Bocquet, François, and Paubel, Pascal. « Les aspects juridiques du développement des médicaments biosimilaires ». RDSS Dalloz, n^o 1 (29 February 2012): 121‑133.

Bogaert, Peter, and Michaux, Geneviève. « La protection administrative des données ». Revue trimestrielle de droit Européen (RTD. Eur.), n^o 1 (15 March 2006): 47.

Borg, John Joseph, Serracino-Inglott, Anthony, Azzopardi, Lilian M. and Schneider, Christian K. « Comment On: “EU’s New Pharmacovigilance Legislation: Considerations for Biosimilars” ». Drug Safety 37, n^o 2 (1^st February 2014): 123‑124.
https://doi.org/10.1007/s40264-013-0128-5.

Boyle, Chris, and Manley, Marie. « New Regulatory Landscape for Biosimilars in the Post Brexit Transition Period ». European Pharmaceutical Review. Accessed 4 July 2022. https://www.europeanpharmaceuticalreview.com/article/143204/new-regulatory-landscape-for-biosimilars-in-the-uk-and-eu-post-brexit-transition-period/.

Bunn, Rachel, and Nutland, Juliet. « Generic Medicinal Products and Their Biological Counterparts. » Pharmaceutical Law Insight 2, n^o 9 (2006): 8‑10.

Calvo, Begoña, and Zuñiga, Leyre. « EU’s New Pharmacovigilance Legislation: Considerations for Biosimilars ». Drug Safety 37, n^o 1 (1^st January 2014): 9‑18.
https://doi.org/10.1007/s40264-013-0121-z.

Chaplin, Steve. « Biosimilars in the EU: A New Guide for Health Professionals ». Prescriber 28, n^o 10 (23 October 2017): 27‑31.
https://doi.org/10.1002/psb.1617.

Cilia, Mark, Ruiz, Sol, Richardson, Peter, Salmonson, Tomas, Serracino-Inglott, Anthony, Wirth, Francesca, and Borg, John Joseph. « Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency’s Committee for Medicinal Products for Human Use ». AAPS PharmSciTech 19, n^o 2 (1^st February 2018): 489‑511.
https://doi.org/10.1208/s12249-017-0892-0.

Courage, Noel, and Parsons, Ainslie. « The Comparability Conundrum: Biosimiliars in the United States, Europe and Canada ». Food and Drug Law Journal 66, n^o 2 (2011): 203‑224.

Dashore, Dipti, and Gohen, Simon. « EMEA: Biosimilars: The Way Forward in Europe. » BIO-Science Law Review 8, n^o 1 (June 2005): 44‑47.

Desmoulin-Canselier, Sonia. « L’évaluation des médicaments à l’ère de la médecine des données ». Revue de Droit Sanitaire et Social, n^o 6 (31 December 2018): 1043‑1054.

Diependaele, Lisa, Cockbain, Julian, and Sterckx, Sigrid. « Similar Or the Same: Why Biosimilars Are Not the Solution Independent Articles ». Journal of Law, Medicine and Ethics 46, n^o 3 (2018): 776‑790.

Dowlat, H. A., Kuhlmann, M. K., Khatami, H., and Ampudia-Blasco, F. J. « Interchangeability among Reference Insulin Analogues and Their Biosimilars: Regulatory Framework, Study Design and Clinical Implications ». Diabetes, Obesity and Metabolism 18, n^o 8 (August 2016): 737‑746.
https://doi.org/10.1111/dom.12676.

Druedahl, Louise C., Kälvemark Sporrong, Sofia, Van de Weert, Marco, De Bruin, Marie Louise, Hoogland, Hans, Minssen, Timo, and Birna Almarsdóttir, Anna. « Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators ». BioDrugs 35, n^o 3 (1^st May 2021): 351‑361.
https://doi.org/10.1007/s40259-021-00478-7.

Emmanouilides, Christos E, Karampola, Maria I, and Beredima, Maria. « Biosimilars: Hope and Concern ». Journal of Oncology Pharmacy Practice 22, n^o 4 (August 2016): 618‑624.
https://doi.org/10.1177/1078155215603232.

Farfan-Portet, María-Isabel, Gerkens, Sophie, Lepage-Nefkens, Isabelle, Vinck, Irmgard, and Hulstaert, Frank. « Are Biosimilars the next Tool to Guarantee Cost-Containment for Pharmaceutical Expenditures? » The European Journal of Health Economics 15, n^o 3 (2014): 223‑228.
https://doi.org/10.1007/s10198-013-0538-4.

Fontès Le Gal, Cécile, and Chiappin, Mathilde. « Biosimilaires : le point sur les notions d’interchangeabilité et de substitution ». Revue générale de droit médical 7, n^o 28 (January 2020): 245‑258.

Forno, Guillermina, and Orti, Eduardo. « Biosimilars: Current Situation and Future Expectations Reports: Biotechnology ». European Journal of Risk Regulation 3, n^o 2 (2012): 213‑218.

Furlani, Pia. « Biosimilars: A Regulatory Review ». Drug Information Journal 42, n^o 5 (1^st September 2008): 477‑485.
https://doi.org/10.1177/009286150804200508.

Garattini, Livio, Curto, Alessandro, and van de Vooren, Katelijne. « Western European Markets for Biosimilar and Generic Drugs: Worth Differentiating ». The European Journal of Health Economics 16, n^o 7 (2015): 683‑687.
https://doi.org/10.1007/s10198-015-0684-y.

Gaumont-Prat, Hélène. « Produits pharmaceutiques – Un an de droit de la propriété industrielle des produits pharmaceutiques – ». Propriété industrielle, n^o 7‑8 (1^st July 2020): 23‑27.

Genovese, Jacqueline. « Biosimilar Naming:  A Call for Uniformity in a Complex Field ». Brooklyn Journal of International Law 41, n^o 1 (1^st January 2015): 292‑327.

Gera, Eshan, Raghunandan, H.V., Kumar, Pramod, and Venkatesh, M.P. « How Similar Should Be A Biosimilar!!! » American Journal of Pharmtech Research, June 2012, 192‑205.

Gitter, Donna. « Informed by the European Union Experience: What the United States Can Anticipate and Learn from the European Union’s Regulatory Approach to Biosimilars ». Seton Hall Law Review 41, n^o 2 (11 November 2011).
https://scholarship.shu.edu/shlr/vol41/iss2/3.

Gravel, P., and Le Cotonnec, J.-Y.. « Qu’est-ce qu’un biosimilaire ? Jusqu’où va la similarité ? » Oncologie 13, n^o 5 (1^st May 2011): 183‑190.
https://doi.org/10.1007/s10269-011-2020-1.

Hallersten, Anna, Fürst, Walter, and Mezzasalma, Riccardo. « Physicians Prefer Greater Detail in the Biosimilar Label (SmPC) – Results of a Survey across Seven European Countries ». Regulatory Toxicology and Pharmacology 77 (1^st June 2016): 275‑281.
https://doi.org/10.1016/j.yrtph.2016.03.021.

Huneycutt, Brenda J., Malkin, Brian J., Van de Wiele, Victor, Williams, Mark P., and Mehta, Rikin. « Regulatory Agency Transparency for Drugs and Biologics: A Comparative Survey of the U.S. Food and Drug Administration, the European Medicines Agency, and Health Canada ». Food and Drug Law Journal 75, n^o 4 (2020): 498‑551.

Huzair, Farah, and Kale, Dinar. « Biosimilars and the Long Game ». Trends in Biotechnology 33, n^o 5 (1^st May 2015): 250‑252.
https://doi.org/10.1016/j.tibtech.2015.01.001.

Islam, Muhammad Sougatul, Alam, Masih Ul, and Amin, Munia. « A Global Perspective of the Prospects and Challenges of an Awaiting Revolution of Biosimilars ». Biojournal of Science and Technology 2 (6 November 2015).
https://bio-journal.com/content/article/2015/11/prospects-and-challenges-of-of-biosimilars.

Juillard-Condat, Blandine, and Taboulet, Florence. « L’encadrement des médicaments biosimilaires à la croisée des logiques sanitaires et économiques ». Journal international de bioéthique et d’éthique des sciences 29, n^o 2 (2018): 87‑111.
https://doi.org/10.3917/jibes.292.0087.

Juillard-Condat, Blandine, and Taboulet, Florence. « L’équivalence thérapeutique : une notion bien équivoque ! » Revue générale de droit médical 4, n^o 24 (January 2017): 49‑66.

Kaldre, Ingrid. « The Future of Generic Biologics: Should the United States “Follow-on” the European Pathway? » Duke Law & Technology Review, n^o 9 (2008): 13.

Kang, Hye-Na, Thorpe, Robin, Knezevic, Ivana, Casas Levano, Mary, Chilufya, Mumbi Bernice, Chirachanakul, Parichard, Chua, Hui Ming, and al. « Regulatory Challenges with Biosimilars: An Update from 20 Countries ». Annals of the New York Academy of Sciences 1491, n^o 1 (2021): 42‑59.
https://doi.org/10.1111/nyas.14522.

Katerina U. « Mutual Recognition of Manufacturing Practices between the European Medicines Agency and the Food and Drug Administration: The Groundwork for the Mutual Recognition of Biosimilars ». Santa Clara Law Review 59 (s. d.): 37.

Kirchhoff, Carol F., Wang, Xiao-Zhuo Michelle, Conlon, Hugh D., Anderson, Scott, Ryan, Anne M., and Bose, Arindam. « Biosimilars: Key Regulatory Considerations and Similarity Assessment Tools ». Biotechnology and Bioengineering 114, n^o 12 (2017): 2696‑2705.
https://doi.org/10.1002/bit.26438.

Kox, Suzette. « The Saga of the Legal Framework for Biogenerics in Europe ». Journal of Generic Medicines 2, n^o 2 (1^st January 2005): 105‑110.
https://doi.org/10.1057/palgrave.jgm.4940058.

Kresse, Georg-Burkhard. « Biosimilars – Science, Status, and Strategic Perspective ». European Journal of Pharmaceutics and Biopharmaceutics 72, n^o 3 (1^st August 2009): 479‑486.
https://doi.org/10.1016/j.ejpb.2009.02.014.

Kretzschmar, Marcus D. « Drug Safe Harbour Provisions in the USA and Europe: Implications for the Emerging Biosimilars Industry. » Journal of Intellectual Property Law & Practice 9, n^o 4 (2014): 298‑311.

Kupfer, Séverine, and Job, Jean-Marie. « Santé publique – Les médicaments biosimilaires : enjeux et stratégie – Étude ». La Semaine Juridique Entreprise et Affaires, n^o 49, (5 December 2013): 27‑33.

Kurki, Pekka, and Ekman, Niklas. « Biosimilar Regulation in the EU ». Expert Review of Clinical Pharmacology 8, n^o 5 (3 September 2015): 649‑659. https://doi.org/10.1586/17512433.2015.1071188.

Lechat, P. « Médicaments biosimilaires : enjeux réglementaires et impacts médico-économiques ». Bulletin de l’Académie Nationale de Médecine 204, n^o 8 (1^st October 2020): 877‑883.
https://doi.org/10.1016/j.banm.2020.07.050.

Manley, Maria Isabel, and Benning-Prince, Sharon. « Is There Any Regulatory Approval Pathway for Biosimilars? | Westlaw UK ». Pharmaceutical Law Insight 3 (2007): 8‑11.

McEnrue, Martin. « Barriers to Biosimilar Approval: Creating Clarity through the Publication of Product-Class Specific Guidances Notes and Comments ». Maryland Journal of International Law 31 (2016): 311‑330.

Minghetti, Paola, Rocco, Paolo, Cilurzo, Francesco, Del Vecchio, Lucia, and Locatelli, Francesco. « The Regulatory Framework of Biosimilars in the European Union ». Drug Discovery Today 17, n^o 1 (1 ^st January 2012): 63‑70.
https://doi.org/10.1016/j.drudis.2011.08.001.

Mora, Fernando de. « Biosimilar: What It Is Not ». British Journal of Clinical Pharmacology 80, n^o 5 (2015): 949‑956.
https://doi.org/10.1111/bcp.12656.

Mounho, Barbara, Phillips, Audrey, Holcombe, Kay, and Grampp, Gustavo. « Global Regulatory Standards for the Approval of Biosimilars ». Food & Drug Law Journal 65, n^o 4 (2010): 819‑838.

Mrozovski, Jean Michel. « Les biosimilaires, des biomédicaments comme les autres ? » Actualités Pharmaceutiques 58, n^o 586 (1^st May 2019): 44‑47.
https://doi.org/10.1016/j.actpha.2019.03.019.

Noor, Marjan. « EMEA: Biosimilars – EMEA Publishes More Guidance on Approval of Biosimilars. » BIO-Science Law Review (BSLR), n^o 7(3) (May 2004): 136‑138.

Paradise, Jordan. « The Legal and Regulatory Status of Biosimilars: How Product Naming and State Substitution Laws May Impact the United States Healthcare System ». American Journal of Law & Medicine 41, n^o 1 (March 2015): 49‑84.
https://doi.org/10.1177/0098858815591509.

Peigné, Jérôme. « La réforme de la législation pharmaceutique communautaire ». RDSS Dalloz, n^o 3 (15 September 2004): 577‑597.

Perroy, Anne-Catherine, and Rimailho, Alain. « Les médicaments biosimilaires à la recherche d’un cadre juridique ». Revue Droit et Santé, n^o 65 (2015): 491‑498.

Prugnaud, Jean-Louis. « Similarity of Biotechnology-Derived Medicinal Products: Specific Problems and New Regulatory Framework ». British Journal of Clinical Pharmacology 65, n^o 4 (2008): 619‑620.
https://doi.org/10.1111/j.1365-2125.2007.03062.x.

Reinivuori, Tiina, Kurki, Pekka, and Chamberlain, Paul. « Immunogenicity Assessment of Biosimilars ». Pharmaceutical Medicine 32, n^o 2 (1 ^st April 2018): 103‑121.
https://doi.org/10.1007/s40290-018-0231-0.

Rozek, Richard P. « Economics as a Guide to Developing Public Policies for Biosimilar Pharmaceutical Products ». Queen Mary Journal of Intellectual Property, 2, n^o 4 (2012): 363‑375.

Schiestl, Martin, Ranganna, Gopinath, Watson, Keith, Jung, Byoungin, Roth, Karsten,  Capsius, Björn, Trieb, Michael, Bias, Peter, and Maréchal-Jamil, Julie. « The Path Towards a Tailored Clinical Biosimilar Development ». BioDrugs 34, n^o 3 (1^st June 2020): 297‑306.
https://doi.org/10.1007/s40259-020-00422-1.

Schiestl, Martin, Zabransky, Markus, and Sörgel, Fritz. « Ten Years of Biosimilars in Europe: Development and Evolution of the Regulatory Pathways ». Drug Design, Development and Therapy 11 (16 May 2017): 1509‑1515.
https://doi.org/10.2147/DDDT.S130318.

Sciberras, Josette, Zammit, Raymond, and Bonanno, Vella. « The European Framework for Intellectual Property Rights for Biological Medicines ». GaBI Journal – Generics and Biosimilars Initiative Journal 10, n^o 4 (16 March 2022): 172‑183.

Tabutiaux, Agnès, and Pecyna, Joanna. « Impact de la réglementation sur l’accès au marché européen des médicaments biosimilaires. Des arbitrages nécessaires entre critères sanitaires et économiques au regard des approches juridiques internationales ». Revue générale de droit médical 5, n^o 26 (January 2018): 249‑267.

Teare, Isabel. « Biosimilar Warfare: The Arrival of Generic Biopharmaceuticals – The Omnitrope Decision ». BIO-Science Law Review (BSLR) 8, n^o 1 (June 2005): 9‑13.

Tsiftsoglou, Asterios S., Ruiz, Sol, and Schneider, Christian K. « Development and Regulation of Biosimilars: Current Status and Future Challenges ». BioDrugs 27, n^o 3 (1^st June 2013): 203‑211. https://doi.org/10.1007/s40259-013-0020-y.

Tsiftsoglou, Asterios S., Trouvin, Jean Hugues, Calvo, Gonzalo, and Ruiz, Sol. « Demonstration of Biosimilarity, Extrapolation of Indications and Other Challenges Related to Biosimilars in Europe ». BioDrugs 28, n^o 6 (1^st December 2014): 479‑486.
https://doi.org/10.1007/s40259-014-0109-y.

Vleminckx, C., and Ehmann, F. « Guidelines EMA pour le développement de médicaments biosimilaires ». Oncologie 13, n^o 5 (1^st May 2011): 191‑195.
https://doi.org/10.1007/s10269-011-2011-2.

Voisin, Emmanuelle, Uguen, David, and Deneux, Marie. « Biosimilars in the EU: Nonclinical and Early Clinical Development ». Drug Information Journal 44, n^o 6 (1^st November 2010): 741‑743.
https://doi.org/10.1177/009286151004400610.

Wang, Jun, and Chow, Shein-Chung. « On the Regulatory Approval Pathway of Biosimilar Products ». Pharmaceuticals 5, n^o 4 (30 March 2012): 353‑368.
https://doi.org/10.3390/ph5040353.

Weise, Martina, Bielsky, Marie-Christine, De Smet, Karen, Ehmann, Falk, Ekman, Niklas, Giezen, Thijs J., Gravanis, Iordanis, and al. « Biosimilars: What Clinicians Should Know ». Blood 120, n^o 26 (20 December 2012): 5111‑5117.
https://doi.org/10.1182/blood-2012-04-425744.

Whitfield, Stephen. « European Commission: Biosimilars. » BIO-Science Law Review 11, n^o 5 (2011): 177‑178.

Wolff-Holz, Elena, Tiitso, Klara, Vleminckx, Camille, and Weise, Martina. « Evolution of the EU Biosimilar Framework: Past and Future ». Biodrugs 33, n^o 6 (2019): 621‑634.
https://doi.org/10.1007/s40259-019-00377-y.

Zuñiga, Leyre, and Calvo, Begoña. « Biosimilars Approval Process ». Regulatory Toxicology and Pharmacology 56, n^o 3 (1^st April 2010): 374‑377.
https://doi.org/10.1016/j.yrtph.2009.11.004.

Zuñiga, Leyre, and Calvo, Begoña. « Biosimilars: Pharmacovigilance and Risk Management ». Pharmacoepidemiology and Drug Safety 19, n^o 7 (2010): 661‑669. https://doi.org/10.1002/pds.1948.