Drugs

Lilly Wants Forteo ANDAs Rejected

Lilly has petitioned FDA asking that the agency refuse to approve any ANDA citing its Forteo (teriparatide [rDNA origin] injection) as the reference-listed drug or reference product, including a specific Teva ANDA. The petition also asks the agency to require that any 505(b)(2) NDA applicant or future biosimilar applicant referencing Forteo demonstrate that the proposed follow-on product is highly similar to and has no clinically meaningful differences from Forteo in terms of safety and effectiveness based on data derived from the analytical studies, bioassay, comparative clinical immunogenicity testing, comparative clinical pharmacokinetic and pharmacodynamics studies, and other studies described in the petition.

It further calls on FDA to determine that a follow-on teriparatide product may not be deemed therapeutically equivalent to Forteo or, if FDA determines that therapeutic equivalence determinations with respect to Forteo are scientifically feasible, not issue such a therapeutic equivalence determination unless the applicant provides specific clinical switching and alternating data.

FDA should use notice and comment rulemaking to revise the regulatory definition of “biological product” to align with the definition in the Public Health Service Act, Lilly says, and on 3/23/20 should deem the Forteo NDA to be a BLA for regulatory approval purposes and require follow-on applications to proceed under section 351(k) of the Public Health Service Act at that time.

An ANDA is inappropriate, Lilly says, because sameness of active ingredient cannot be shown since teriparatide is a recombinantly-derived amino acid polymer with 34 amino acids.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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