India's biosimilar regulations

Indias last bastion of polio at "tipping point".

Biosimilar Therapeutic Monoclonal Antibodies

Last month, Part 1 of this discussion brief ly described the regulatory landscape for developing biosimilar therapeutic monoclonal antibodies (TMAbs). We identified certain specific structural components of TMAb drug substances that warrant particular attention because alterations to them are likely to affect therapeutic safety and effectiveness. Now we conclude by considering whether studies o...

Safety Regulations Safety Regulations Environments for Safety Regulations

Environments for Safety Regulations A common factor in whether regulation is used is the seriousness of the outcome being addressed in terms of human health. For this reason regulation is more common in transportation and the workplace, where the potential for fatal injury is perceived to be relatively great, and less common in the home and in sports environments, where the potential for fatal ...

Biosimilar medicines and cost-effectiveness

Given that biosimilars are agents that are similar but not identical to the reference biopharmaceutical, this study aims to introduce and describe specific issues related to the economic evaluation of biosimilars by focusing on the relative costs, relative effectiveness, and cost-effectiveness of biosimilars. Economic evaluation assesses the cost-effectiveness of a medicine by comparing the cos...

The Future of Biosimilar Insulins

IN BRIEF Biosimilar insulins are available in many countries and will be made available in the United States in the near future. Some concerns associated with biosimilar insulins include potential differences in the efficacy and safety between a biosimilar product and its reference insulin, the ramifications of having the same name or different names for a biosimilar and its reference insulin, ...