A ‘Global Reference’ Comparator for Biosimilar Development

A Reference Model for Global Software Development

The objective of this paper is to propose a reference model for global software development, based on the results found in a case study conducted in two software development units from multinational organizations located in Brazil. Since the number of organizations distributing their software development processes worldwide keeps increasing, this change is having a profound impact on the way pr...

Establishment of reference standards in biosimilar studies.

When an innovative biological product goes off-patent, biopharmaceutical or biotechnological companies may file an application for regulatory approval of biosimilar products. In practice, however, important information on the innovative (reference) product may not be available for assessment. Thus, it is important to first establish a reference standard while assessing biosimilarity between a b...

Alternative statistical strategies for biosimilar drug development

Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges

Biosimilars are biological medicinal products that contain a version of the active substance of an already authorised original biological medicinal product (the innovator or reference product). The first approved biosimilar medicines were small proteins, and more recently biosimilar versions of innovator monoclonal antibody (mAb) drugs have entered development as patents on these more complex p...

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...