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.

This content is written, edited and published by EP Vantage and is distributed by Evaluate Ltd. All queries regarding the content should be directed to: news@epvantage.com

EP Vantage is a unique, forward-looking, news analysis service tailored to the needs of pharma and finance professionals. EP Vantage focuses on the events that will define the future of companies, products and therapy areas, with detailed financial analysis of events in real-time, including regulatory decisions, product approvals, licensing deals, patent decisions, M&A.

Drawing on Evaluate, an industry-leading database of actual and forecast product sales and financials, EP Vantage gives readers the insight to make value-enhancing decisions.

EP Vantage SM ©2018 EP Vantage Ltd