Declerck, Paul × Darendeliler, Feyza Goth, Miklos Kolouskova, Stanislava Micle, Ioana Noordam, Cees Peterkova, Valentina Volevodz, Natalia N Zapletalova, Jirina Ranke, Michael B #
Current medical research and opinion vol:26 issue:5 pages:1219-1229
Background and scope:
Similar biological medicinal products, also called ‘biosimilars’, are copies of biopharmaceutical products whose patent has expired. Whether biosimilars are truly comparable and interchangeable with their reference biopharmaceutical products in terms of quality, efficacy and tolerability, is still a matter of debate. This review discusses the controversies related to the criteria for regulatory approval of biosimilars. These concerns are illustrated using recombinant human growth hormone (rhGH) biosimilars
as an example.