Sandoz Lands Recommendation for Biosimilar of Enbrel

Sandoz’s biosimilar of Amgen’s Enbrel has received a recommendation of approval from an FDA advisory committee.

The robustness of the analytical studies, which showed that GP2015 is highly similar to Enbrel, prompted the 20-0 vote, committee members said last week.

Accompanying clinical evidence showed an equivalent response in patients dosed with the candidate and reference drug for psoriasis patients, which the committee said warranted extrapolation for the five proposed indications Sandoz sought.