A biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product.
Generics News
Padagis was granted 180 days of Competitive Generic Therapy exclusivity.
The approval of the new citrate-free, high-concentration formulation was based on data from a phase 1 pharmacokinetics bridging study.
Emzahh is an AB-rated generic equivalent of Ortho Micronor.
The approval for Idacio was based on a review of data that showed similar pharmacokinetics, efficacy, safety, and immunogenicity to the reference adalimumab product.
The approval was granted Competitive Generic Therapy exclusivity meaning the Company will have 180 days exclusivity.
Haloette is an estrogen/progestin combination hormonal contraceptive.
Romidepsin is a histone deacetylase inhibitor indicated for the treatment of cutaneous T-cell lymphoma.
The approval was based on data demonstrating a high degree of similarity of Fylnetra to the reference product, with no clinically meaningful differences.
The generic version is available in 2 dosage strengths.
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