Biological anticancer therapies developed in recent decades have contributed to improvements in patient care for serious illnesses. Patents for several biologics will soon expire, paving the way for initiating approval processes for biosimilarsddefined as highly similar versions of already licensed or approved biological therapies. The aim of developing a biosimilar is to establish similarity i...

A biosimilar is a biopharmaceutical product intended to be comparable to a previously licensed biopharmaceutical agent. The goal of such products is to increase the accessibility of biopharmaceutical therapy for rheumatoid arthritis by reducing costs. They are not like generic drugs, in that they may differ from the reference products in manufacturing, composition, and formulation. Regulatory a...

A biosimilar product needs to demonstrate biosimilarity to the originator reference product, and the quality profile of the latter should be monitored throughout the period of the biosimilar's development to match the quality attributes of the 2 products that relate to efficacy and safety. For the development of a biosimilar version of trastuzumab, the reference product, Herceptin®, was extensi...

Pharmaceutical industry sectors are at odds as the Food and Drug Administration seeks to define "interchangeability" for biosimilars. The battle lines vary by topic, but biosimilar marketers, health plans, and drugstores are generally urging lower hurdles.

Biosimilars are protein products that are sufficiently similar to a biopharmaceutical already approved by a regulatory agency. Several biotechnology companies and generic drug manufacturers in Asia and Europe are developing biosimilars of tumor necrosis factor inhibitors and rituximab. A biosimilar etanercept is already being marketed in Colombia and China. In the US, several natural source pro...

The use of biological medicine has significantly increased in recent decades and has made substantial contributions to improving the effectiveness of therapies in many diseases. The expiration of patents of biological innovative medicines enables copies of those drugs called similar biological products (biosimilars) to be approved by regulatory authorities and to enter in clinical use. Biosimil...

Biosimilar medicinal products (biosimilars) have become a reality in the European Union and will soon be available in the United States. Despite an established legal pathway for biosimilars in the European Union since 2005 and increasing and detailed regulatory guidance on data requirements for their development and licensing, many clinicians, particularly oncologists, are reluctant to consider...

Biologic agents are an important therapeutic option in the treatment of patients with rheumatic diseases, including RA [1], AS [2] and PsA [3, 4]. Despite the positive attributes of these agents in the treatment of these conditions, patients are unlikely to receive biological agents as firstline therapy, and barriers to their use as second-line therapy (and beyond) may also occur [5]. This larg...

We present EULAR sessions on the latest treatments for rheumatic disease with an infliximab biosimilar, certolizumab pegol, secukinumab, and bimekizumab. We also report on significant developments in diabetes presented at ADA's Scientific Sessions.

PL A biosimilar is a biologic drug that has been produced to closely resemble a drug whose patent has expired. Thus, a biosimilar is very similar, but not identical, to the originator drug. As of January 14, 2016, 22 biosimilars have been approved by the European Medicines Agency. Treatment areas include diabetes (insulin; Abasaglar, Lilly), neutropenia/anemia (filgrastim; Accofil, Accord and F...