The Food and Drug Administration (FDA) has approved the first so-called biosimilar drug for use in the United States, paving the way for alternatives to an entire class of complex drugs.
“As the FDA becomes more comfortable … we’re going to see biosimilars get through a lot more easily,” predicted Jitty Malik, partner in Alston & Bird’s Intellectual Property Litigation Group who specializes in intellectual property and drug-approval issues. “The first one’s always the hardest to get through, because the FDA is more cautious – it’s uncharted territory.”
“As the FDA becomes more comfortable … we’re going to see biosimilars get through a lot more easily,” predicted Jitty Malik, partner in Alston & Bird’s Intellectual Property Litigation Group who specializes in intellectual property and drug-approval issues. “The first one’s always the hardest to get through, because the FDA is more cautious – it’s uncharted territory.”