And Now For The Real Biosimilar Opportunity: Antibodies And Complex Biologics
With patents on blockbuster drugs – including Roche/Biogen Idec Inc.'s Rituxan (rituximab), Amgen Inc./Pfizer Inc.'s Enbrel (etanercept) and Roche's Herceptin (trastuzumab) – due to expire in key markets within the next three years, there's a renewed buzz around biosimilars as industry players seek to grab a share of this multi-billion dollar opportunity.
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EMA’s biosimilars interferon beta guideline, which says that magnetic resonance imaging of disease lesions may be enough to demonstrate similarity. More important perhaps, it’s the first guidance issued under the watch of new EMA chief Guido Rasi, who strongly supports allowing single data package for EU and U.S. biosimilar medicines.
The deal is a key part of both companies’ plans for aggressive international expansion because they will be able to spread fixed costs and offer robust portfolios to vastly different geographically diverse customers.
The partners’ flexibility allows them, together and separately, to establish solid footholds in a still-evolving field with plenty of potential but also uncertainties.