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Unlike with generic drugs of the more common small-molecule type, biosimilar drugs generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes. Despite this heterogeneity, all biopharmaceuticals , including biosimilars, must maintain consistent quality and clinical performance throughout their ...
In determining bioequivalence between two products such as a commercially available Branded product and a potential to-be-marketed Generic product, pharmacokinetic studies are conducted whereby each of the preparations are administered in a cross-over study (sometimes parallel study, when a cross-over study is not feasible) to volunteer subjects, generally healthy individuals but occasionally ...
Specialty drugs, a recent classification of pharmaceuticals, are high-cost drugs that are often biologics. [ 7 ] [ 8 ] [ 9 ] The European Medicines Agency uses the term advanced therapy medicinal products (ATMPs) for medicines for human use that are "based on genes, cells, or tissue engineering", [ 10 ] including gene therapy medicines, somatic ...
The U.S. Food and Drug Administration is holding a two-day public hearing to start the process of creating an abbreviated approval procedure for so-called biosimilar and interchangeable biological ...
The applicant for this medicinal product is CuraTeQ Biologics s.r.o. [13] Zefylti is a biosimilar medicinal product. [13] It is highly similar to the reference product Neupogen (filgrastim), which has been authorized in various EU countries. [13] Zefylti was authorized for medical use in the European Union in February 2025. [14]
(Reuters) -The U.S. Food and Drug Administration (FDA) on Monday approved two close copies of Regeneron Pharmaceuticals' Eylea, its first-ever clearance to biosimilar versions of the blockbuster ...
csDMARDs are the traditional drugs (such as methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, gold salts) tsDMARDs are drugs that were developed to target a particular molecular structure; biological (bDMARD) can be further separated into original and biosimilar DMARDs (boDMARDs and bsDMARDs)
List of Antiviral Drugs Antiviral Use Manufacturer Component Type Year approved Abacavir: HIV: ViiV Healthcare: Nucleoside analogue reverse transcriptase inhibitor (NRTI) 1998 Acyclovir (Aciclovir) Herpes Simplex, chickenpox, [2] varicella zoster virus: GSK: guanosine analogue RTI 1981 Adefovir: Hepatitis B [3] Gilead Sciences RTI 2002 , 2003 ...