There are a few biosimilars on the European market at present, but growing interest is being spurred by a number of top selling biologicals about to come off patent in the next five years.

Biosimilars characteristics differ from generics, which have simple, small chemical structures. The complexity of biological products makes the standard generic drug procedure, based on bioequivalence, not applicable. The complicated biological production process is kept a company secret. Disclosure of the production process could lead to easier and more exact copying of the originator.

The often-mentioned concern about the quality of generics should not play a major role for biosimilars. Not only are there only a few manufacturers, but most of them are well-established companies in the pharmaceutical field.

Like generics, biosimilars will find it difficult to earn a place in the pharmaceutical arsenal unless they introduce considerable savings for health authorities. The manufacturers’ claim that price cuts on biosimilars should be much smaller than on generics seems questionable. Tenders could be the most effective tool to cut biosimilars’ prices. However, the bid needs to be designed so that competition can produce its effects, by at least allowing more than one manufacturer to compete for the same lot.

The main hurdle for diffusion of biosimilars at present seems to be international patent regulation. Opening up production secrecy well before patent expiry would help biosimilars contribute more to sustainable pharmaceutical expenditure.

Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.

Abstracted by Professor Livio Garattini, member of the International Editorial Advisory Board, GaBI Journal.

Editor’s comment
Readers interested to learn more about biosimilars from a payer’s perspective and regional tenders on biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Health authority perspective on biosimilars

Regional tenders on biosimilars in Italy: potentially competitive?

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

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Patient perceptions of generics in Ireland

Reference
1.  van de Vooren K, Curto A, Garattini L. Biosimilar versus generic drugs: same but different? Appl Health Econ Health Policy. 2015 Feb 5. [Epub ahead of print]

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