Drugs

Apotex Petitions to Hold Neulasta Biosimilars to Higher Approval Bar

Apotex has petitioned FDA to impose stricter requirements for applicants seeking approval for a biosimilar product referencing Amgen’s Neulasta (pegfilgrastim). The petition wants applicants to “conduct their comparative clinical efficacy studies (including pharmacokinetics (PK) and pharmacodynamics (PD) studies and immunogenicity studies) in at least one intended patient population.” Apotex maintains that comparative clinical studies administering pegfilgrastim alone would not demonstrate “no clinically meaningful differences” between a proposed biosimilar and Neulasta for one of the indications for Neulasta.

“To the extent that FDA accepts a clinical study design only in healthy subjects, FDA should require such biosimilar applicants to demonstrate that there is a correlation in ANC [absolute neutrophil counts] activity and a reduced incidence of infection over the duration of exposure to pegfilgrastim in the indicated patient population,” Apotex says. “This is because the literature demonstrates that cancer chemotherapy patients process pegfilgrastim more slowly and are exposed to pegfilgrastim for much longer than healthy subjects, thus undermining the conclusion that the comparison does not reveal clinically meaningful differences in the intended patient population.” Apotex also asks FDA to require that biosimilar applicants conduct immunogenicity studies over at least four and preferably six cycles, which reflects a typical initial chemotherapy course.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome