JOURNAL ARTICLE

What are biosimilars and are they important?

(no author information available yet)
Drug and Therapeutics Bulletin 2013, 51 (5): 57-60
23657197
All prescribers will be familiar with the issues associated with the use of branded and generic 'chemical' medicines.(1) For biological products (e.g. epoetin, filgrastim), a biosmilar medicine is a new biological product that is similar to a medicine that has already been authorised to be marketed in the EU (the biological reference medicine).(2) Six biosimilar medicinal products are currently marketed in the UK-three versions of filgrastim (▾Nivestim, ▾Tevagrastim and Zarzio),(3-5) two versions of epoetin (Binocrit and Retacrit)(6,7) and one version of somatropin (Omnitrope).(8) Applications for biosimilar versions of follitropin alfa and infliximab are under evaluation by the European Medicine's Agency (EMA) Committee for Medicinal Products for Human Use.(9) In the future there may also be biosimilar versions of insulins, recombinant vaccines, interferons and monoclonal antibodies such as rituximab and trastuzumab.(10) It is estimated that about 50% of the current UK market for biological medicines by spend may be subject to biosimilar competition by 2019. In this article, we will consider the background to developing biosimilar medicines, how and why they differ from traditional generic medicines in their licensing requirements and the issues that may arise as they are introduced to clinical practice.

Full Text Links

Find Full Text Links for this Article

Discussion

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

Related Papers

Remove bar
Read by QxMD icon Read
23657197
×

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"