Irene Krämer
Therapeutische Umschau. Revue Thérapeutique 2011, 68 (11): 659-66
Biosimilars are biological medicinal products referring to an existing biological originator product and submitted to regulatory authorities formarketing authorization by an independent applicant after the patent has expired. The European Medicines Agency (EMA) has issued overarching and specific guidelines that should be fulfilled in order to receive approval as biosimilar. In accordance with these guidelines biosimilars of recombinant somatropin, epoetin alfa, and granulocyte-colony stimulating factor have gained market authorisation in the EU. Similarity in terms of quality, safety and efficacy to a reference product was demonstrated. Points to consider when switching from the innovator product to a biosimilar, or from one biosimilar to another, are reported. INN-naming, labelling, pharmacovigilance issues, interchangeability, and substitution of biosimilars are still a matter of discussion.

Full Text Links

Find Full Text Links for this Article


You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Remove bar
Read by QxMD icon Read

Save your favorite articles in one place with a free QxMD account.


Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"