The FDA has licensed the pentavalent vaccine Penmenvy (GSK) for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, B, C, W, or Y (MenABCWY) in persons 10-25 years old. Penmenvy is the second pentavalent meningococcal vaccine to become available in the US; Penbraya was licensed in 2023.1
MENINGOCOCCAL DISEASE — Six serogroups of N. meningitidis (A, B, C, W, X, and Y) cause most cases of invasive meningococcal disease worldwide. Most US cases are caused by serogroups B, C, and Y....
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RELEASE
Omlyclo (omalizumab-igec; Celltrion), a biosimilar product interchangeable with the recombinant anti-IgE monoclonal antibody Xolair, has been approved by the FDA for same indications as Xolair (see Table 1). Omlyclo is the first Xolair biosimilar to be approved in the US.
REGULATORY STATUS — A biosimilar is a biologic product that is highly similar in composition and strength and has no clinically meaningful differences in safety, purity, and potency to the FDA-approved reference product. For a biosimilar to be approved as an interchangeable product, the manufacturer generally conducts clinical trials to prove that the results will be the same if the patient switches between the reference product and the biosimilar. In clinical studies, there were no clinically significant differences in efficacy, …