Abstract

• "Biosimilar" drug regulatory status, created in 2004 for copies of "biological" drugs, is far more onerous than "generic" drug status.
   
• The possibility of substituting a cheaper copy for an originator drug once its market monopoly has expired has major implications for the efficient management of healthcare expenditure. The context surrounding the creation of the concept of "biosimilarity" was one of originator pharmaceutical companies trying to defend their turf by preventing copies of biotechnology-derived drugs from acquiring the status of generics.
   
• While generic drugs are authorised on the basis of an abridged application, companies that wish to market a copy of a biotechnology-derived drug must provide the results of specific preclinical tests and clinical trials. The reasons put forward are, in particular, technical difficulties in establishing the similarity of complex biological substances.
   
• In May 2013, the European Medicines Agency (EMA) released for public consultation a draft revision of its guidelines on the evaluations required to obtain marketing authorisation for copies of "biological" drugs. This EMA proposal would relax a number of requirements that are of little value to patients and delay the market introduction of these copies. In late 2014 and early 2015, the EMA adopted the final version of these guidelines.
   
• The response of the Medicines in Europe Forum and the International Society of Drug Bulletins (ISDB) to this consultation provided an opportunity to review the current situation regarding "biosimilars", ten years after this regulatory status was created.
   
• These two international networks supported the EMA’s pragmatic proposals to no longer require that clinical trials be routinely conducted before "biosimilar" drugs can be authorised.
  
  
• This response also provided an opportunity to stress that unless a difference in efficacy or adverse effects is demonstrated, assigning a different international nonproprietary name (INN) from that of the originator drug would lead to a profusion of names for the same drug and cause unnecessary confusion for healthcare professionals and patients.
   

©Prescrire 1 Febuary 2015

""Biosimilars": towards fewer obstacles to their use" Prescrire Int 2015; 24 (157): 80-83. (Pdf, subscribers only)