Biological oncology products are integral to cancer treatment, but their high costs pose
challenges to patients, families, providers, and insurers. The introduction of biosimilar …

Since the introduction of the first infiximab biosimilar, Inflectra [R], signif cant changes have
taken place in the Canadian biosimilar landscape, and both the regulatory and the …

Biosimilar products are already approved and marketed in several countries. The Food and
Drug Administration has approved ten different biosimilars, and the European Medicines …

Biosimilars started receiving the marketing authorization by European Medicine Agency
since 2006. The development of biosimilars follows a well-defined step-wise approach, the …

The treatment of many diseases, particularly cancer, has been profoundly impacted by the
introduction of biologic therapies (biologics), which are incorporated into the treatment …

The use of biotech medicines is increasing, with consequent mounting expenses for
National Health Systems (NHSs). Biosimilars should be considered an opportunity to …

Fifteen years of experience with biosimilar evaluation in Europe and advancement in the
science behind biological medicines, provides a timely moment to open up debate as to …

Biologicals are distinct from small molecule drugs in that they are larger, more structurally
complex agents. While the overall risk is modest, the active protein structure characteristic of …

Biological drugs are vital but often high-cost components of cancer treatment. Several
biosimilar versions of these drugs have been approved in Europe and/or the USA, with …

Biosimilars have the potential to broaden patient access to biologics and provide cost
savings for health care systems. During the development of a biosimilar, data that directly …