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EP Biosimilar Competition Causes a Drop in Sales for Remicade

Remsima, a biosimilar of Remicade (infliximab), was granted a marketing authorization throughout the European Union in 2013.  Last week, Merck reported a 30% drop in Remicade first-quarter sales due to “the accelerating impact of biosimilar competition in the company’s marketing territories in Europe.”  This will likely be the trend as…

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Amgen v. Hospira: Court Considers Issues Regarding the Scope of Discovery and the RPS’s Ability to Assert Additional Patents in BPCIA Actions

In a recent hearing held in Amgen v. Hospira, the parties offered arguments on  some novel issues relating to litigation under the BPCIA, particularly: Whether a reference product sponsor (“RPS”) can compel a biosimilar applicant to produce manufacturing information that may be relevant to other patents it holds, but is…

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