Worldwide experience with biosimilar development

Worldwide experience with biosimilar development

Limited access for high-quality biologics due to cost of treatment constitutes an unmet medical need in the United States (US) and other regions of the world. The term "biosimilar" is used to designate a follow-on biologic that meets extremely high standards for comparability or similarity to the originator biologic drug that is approved for use in the same indications. Use of biosimilar produc...

Biosimilar Development: the Race to Market Continues..

2012 will certainly be memorable as an Olympic year, but it has also seen a flurry of activity in the race to market biosimilar products. Keen to participate in this event, many countries throughout the world have established legal and regulatory pathways which allow manufacture of “copies” of a patent-expired biotherapeutic product. However, these are not simple generics as in the case of smal...

Development and Rheological Profiling of Biosimilar Mucus

This article presents the development of a biosimilar mucus mixture for assessment of the effect of mucus on drug absorption. The biosimilar mucus was optimized to represent a rheological profile similar to that of porcine intestinal mucus. This was obtained with a mixture of mucin, polyacrylic acid, lipids and BSA. INTRODUCTION The viscoelastic mucus layers covering the epithelial surfaces are...

Regulatory considerations in oncologic biosimilar drug development

Biosimilar monoclonal antibodies are being developed globally for patients with different types of solid tumors and hematologic malignancies. Applications for proposed biosimilar monoclonal antibodies are being submitted to the regulatory authorities around the world and may increase patient access to key treatment options upon approval. An understanding among stakeholders (e.g., physicians, pa...

Alternative statistical strategies for biosimilar drug development