Is FDA do­ing enough to bring biosim­i­lars to mar­ket? Ex­perts dis­cuss

As the num­ber of biosim­i­lar ap­provals con­tin­ues to rise in the US, the num­ber of biosim­i­lar launch­es con­tin­ues to lag, but ex­perts ex­plained how this is more of a le­gal is­sue than a prob­lem with the FDA.

Chad Land­mon, part­ner at Ax­inn, Vel­trop & Harkrid­er LLP, of­fered an overview on Mon­day at the As­so­ci­a­tion of Ac­ces­si­ble Med­i­cines’ con­fer­ence in Bethes­da, MD, of the biosim­i­lar “patent dance,” which is the con­vo­lut­ed and of­ten un­cer­tain process by which the patent is­sues are re­solved ahead of a biosim­i­lar’s launch.

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