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US biosimilar rules due by year end

Date November 23, 2011

As the long-awaited publication of biosimilar approval rules in the US approaches, Amgen’s efforts to wall Enbrel off from copycat rivals show the extent to which patents will be a growing part of protecting biologicals from new competition (Amgen's Enbrel patent extension useful rather than crucial, November 23, 2011).

Molecular complexity and regulatory ambiguity have proven a major barrier for market challengers in spaces such as immunoglobulins and antibodies. However, with the potential for a new wave of biosimilars to chisel away at the sales of longstanding brands, the same lifecycle extension tactics used by small-molecule drug makers may take on a greater significance for their biotech brethren.

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