Biotechnological drugs (BTDs) are complex molecules whose manufacturing process precludes the ability to identically reproduce the structure of the original product, and therefore there cannot be an absolute equivalence between the original (innovative) medication and its biosimilar counterpart. BTDs have been proven useful in the treatment of several rheumatic diseases, however their high cost...

PURPOSE An update on scientific and regulatory challenges in the rapidly evolving field of biosimilar product development is presented. SUMMARY The U.S. market for biosimilar products (i.e., highly similar "follow-on" versions of approved biological drugs) is expected to expand with establishment of an expedited-approval pathway for biosimilars similar to that implemented in European Union co...

Background We studied the comparative effectiveness of biosimilar filgrastim vs original filgrastim in patients with chemotherapy-induced neutropenia. Patients and methods This multicenter, observational study was conducted at 14 centers. The study included 337 patients experiencing neutropenia under chemotherapy. Patients were given either filgrastim 30 MIU or 48 MIU (Neupogen®) or biosimila...

In recent years, 2D-LC has been highly promising for the detailed characterization and comparability assessment of protein biopharmaceuticals such as monoclonal antibodies. This Application Note describes the use of the Agilent 1290 Infinity II 2D-LC solution in the comparison of an infliximab originator and candidate biosimilar. RPLC×RPLC and SCX×RPLC peptide mapping revealed important differe...

The regulation of biosimilars is a process that is still developing. In Europe, guidance regarding the approval and use of biosimilars has evolved with the products under consideration. It is now more than 3 years since the first biosimilar agents in oncology support, erythropoiesis-stimulating agents, were approved in the EU. More recently, biosimilar granulocyte colony-stimulating factors hav...

INTRODUCTION A biosimilar is a biological medicine that is developed to be similar to an existing biologic, with the active component of the biosimilar being essentially the same biological substance as its reference product. A wide variety of biosimilars are available, from relatively small molecules such as human insulin or erythropoietin, to complex molecules such as monoclonal antibodies. B...

BACKGROUND Recombinant granulocyte colony-stimulating factor (G-CSF) is widely used to mobilize haematopoietic stem cells. We compared the efficacy and safety of a biosimilar G-CSF (Zarzio(®), Sandoz Biopharmaceuticals) with the originator G-CSF (Neupogen(®), Amgen) in patients with haematological malignancies. METHODS A total of 108 patients were included in this study, 59 of whom were femal...

As first biosimilar approval nears, key questions remain.

Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents-molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs-provide opportunities both to improve health-care access and outcomes, and to reduce costs...

With the imminent expiry of patents on a number of biological products on the market, the development of biosimilars (or 'follow-on biologics') creates an increasing opportunity in the biotechnology industry. Although general guidelines on the quality and safety of biological products also apply to biosimilars, there is a need to address specific requirements for developing biosimilar drugs. Si...