Wednesday, August 18, 2010

Biosimilars: To develop as a generics or new products?

In a recent article written by Thomas Gryta at the Dow Jones Newswire, he looks at the current situations for large Pharma when developing biosimilars: treat them as generics or new products? While there is now a pathway to have biosimilars approved, the FDA is still yet to provide the guidance on how they are suppose to be developed. Many companies are making their own decisions before the FDA officially ways in. They're looking to secure the market that will come from biosimilars being marketed under individual names. Read Gryta's full article here.

Which path should companies developing biosimilars follow? The generic route or a new product route? How much of a factor is it that the generics are large molecules when it comes to this decision?

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