Monoclonal antibody biologic therapies, introduced nearly 20 years ago, revolutionized the treatment of inflammatory bowel disease (IBD) and are now well established as the most effective agents available. As the first of these biologic agents starts to come off patent, biosimilar agents have emerged as alternatives to originator drugs. The unique drug development and manufacturing processes in...

FDA deluged with opinions on biosimilar naming plans.

Monoclonal antibodies have become mainstays of treatment for many diseases. After more than a decade on the Canadian market, a number of authorized monoclonal antibody products are facing patent expiry. Given their success, most notably in the areas of oncology and autoimmune disease, pharmaceutical and biotechnology companies are eager to produce their own biosimilar versions and have begun ma...

A phase 1 pharmacokinetic (PK) and pharmacodynamic (PD) study was conducted to demonstrate similarity of a proposed pegfilgrastim biosimilar to its reference product. In a single-dose, randomized, assessor-blinded, 2-way crossover, active-controlled PK/PD study, 66 healthy adults received the proposed pegfilgrastim biosimilar and US-licensed pegfilgrastim reference product. Primary end points w...

A biosimilar is a biological medicinal product that is comparable to a reference medicinal product in terms of quality, safety, and efficacy. SB4 was developed as a biosimilar to Enbrel® (etanercept) and was approved as Benepali®, the first biosimilar of etanercept licensed in the European Union (EU). The quality assessment of SB4 was performed in accordance with the ICH comparability guideline...

BACKGROUND Exogenous replacement of erythropoietin (EPO) by recombinant human EPO has been considered a standard of care for the treatment of anemia in patients with chronic kidney disease for more than 20 years. Genetically engineered biologic proteins derived from human, animal, or microorganism sources are a major area of growth in modern medical care, accounting for one-third of new drug ap...

BACKGROUND Biosimilars are similar but non-identical versions of existing biological drugs. The HEXAFIL study was an observational study that assessed the clinical usage, safety and efficacy of the biosimilar filgrastim in routine clinical practice in Germany. PATIENTS AND METHODS A total of 1,337 cancer patients received the biosimilar filgrastim for primary prophylaxis (PP), secondary proph...

OBJECTIVE Bevacizumab is an important component in the treatment of various cancers, and despite guidelines recommending its use in both ovarian and cervical cancer, patient access to bevacizumab and other angiogenesis inhibitors is limited. Biosimilars are large, structurally complex molecules that are intended to be highly similar to, and treat the same condition(s) as, an existing licensed o...

Comparability between a biosimilar and its reference product requires the evaluation of critical quality attributes that may impact on its pharmacological response. Herein we present a physicochemical characterization of a biosimilar trastuzumab focused on the attributes related to the pharmacokinetic response. Capillary isoelectrofocusing (cIEF) and cation exchange chromatography (CEX) were us...

Insulin analog patent expiry is likely to mean that, increasingly, copies of original biopharmaceutical products will be submitted for authorization. Experience with biosimilars in other therapeutic areas suggests that careful regulation and caution are needed. Published guidelines of regulatory authorities around the world on approval of biosimilars and, where available, insulin biosimilars we...