The long awaited promise of biosimilars takes another step to fulfilment with the first approval in Europe of high-value second generation products. But what products can be expected to follow, who is developing them and what are the hot prospects?
Biosimilars: another milestone passed
At the end of June 2013, the European Medicines Agency’s Committee for Medical Products for Human Use issued a positive opinion for the first biosimilar version of Johnson & Johnson’s infliximab for the treatment of rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis. For the two successful applicants, Celltrion and Hospira, this development passes a significant milestone for the whole biosimilar sector as the products are the first monoclonal antibody (mAb) therapies to reach a positive opinion following review via the EMA biosimilars regulatory pathway. This is an important event which heralds a new era of lower-cost biological therapies in Europe.
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Table of Content
Foreword & Executive Summary
- Biosimilars: What Are They and Why
- Are We Interested?
- What Is A Biotech Drug?
- Biosimilars and Biobetters Defined
Product Analysis Each product review which follows covers, where appropriate,
- Mode of Action
- Competition within the Marketplace
- Sales Trends
First Generation Biosimilars Erythropoietin
- Epogen/Eprex/Procrit (epoetin alfa)
- Aranesp (darbepoetin alfa)
- NeoRecormon (epoetin beta)
- Mircera (methoxy polyethylene glycolepoetin beta) Biosimilar Erythropoietin
- Rest of the World (Epoetin & Darbepoetin)
- Neupogen (filgrastim)
- Neulasta (pegfilgrastim)
- Neutrogin/Granocyte (lenograstim)
- Biosimilar G-CSF
- Europe (Filgrastim and Pegfilgrastim)
- Rest of the World