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BioCentury 05.12.13 - [1] After 7 Years

EMA's Richardson: Biosimilars uptake a "little bit slow" but "price competition is certainly there." Amgen's Moore: With 29 healthcare systems, price discounts "non-existent" in some Euro markets.

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BioCentury 05.12.13 - [2] Substitutability

Richardson: Very high quality is "foundation stone" of biosimilars; can drive down amount of data required. Moore: Double-digit growth of biosimilars in Europe happening without substitution. Norway's attempt at substitution.

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BioCentury 05.12.13 - [3] Biosimilar mAbs

Richardson: Monoclonal complexity varies; EMA review depends on "quality characterization." Infliximab decisions soon. Moore on Amgen biosimilars: An "interesting scientific endeavor" in "trying to clone existing products."

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BioCentury 05.12.13 - [4] Harmonization

Richardson: EMA, FDA working on mutual recognition of biosimilar clinical trials. Moore: Harmonization could streamline expenses "if it's done right." Europe first on biosimilars because innovator patents expired there first.

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