FDA Approves Momenta/Sandoz' Lovenox Generic Without Need For Clinical Studies
FDA approval of Momenta and Sandoz' generic version of Sanofi-Aventis' Lovenox (enoxaparin) suggests the agency is willing to find a way around requiring clinical efficacy and safety data for future biosimilar approvals
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Copaxone Generics: FDA Approval Standards Defy Teva’s Argument On Complexity
Sandoz/Momenta’s Glatopa (glatiramer) met four criteria for equivalence that ‘provide overlapping and confirmatory evidence of active ingredient sameness,’ FDA says.
FDA Heparin Immunogenicity Guidance Addresses ANDA Approvals, Brand Changes
Guidance formalizes five criteria FDA used in making a “sameness” determination for Momenta/Sandoz’s enoxaparin ANDA and lays out an approach to assessing the effect of post-approval NDA changes on a product’s immunogenicity without the need for clinical trials.
MS Boon: Many Drugs On The Way, But Will Payors Swallow The Cost?
Several new drugs for multiple sclerosis could launch within the next two years, but amid escalating drug costs, payors are taking a harder look at the therapeutic category. New drugs will face increasing reimbursement hurdles, as payors implement the first prior authorization and step therapy protocols and look for ways to implement further cost reductions.