World Health Organization first bio-similar pre-qualification

WHO (World Health Organization), pre qualified their first bio-similar.

This newly pre qualified medicine is Samsung Bioepis’ Ontruzant which is a bio-similar version of trastuzumab.

After assessment WHO stated that this product is comparable to its originator in terms of efficacy, safety and quality. Thus, making it eligible for procurement by many national health systems and United Nations agencies.

This would see the alleviation of inaccessible treatment and high cost of medicines for many in poor countries, providing affordable breast cancer treatment for all women.

The cost of this new pre-qualified medicine would be 65% lower than Rituxan making it affordable for many healthcare systems in developing countries.

Transformation Of Digital Health for Regulatory Professionals

November 2019 saw a large focus on the changing digital health landscape alongside big data so what does this mean for regulatory professionals.

With opportunities and challenges in technology making exponential breakthroughs for digital health solutions in today’s society. Accessibility, convenience, and mobility have formed a cultural shift in the way we use, process and provide healthcare solutions.

This transformational shift has changed how an individual uses and obtains information from products and users in a real-world scenario, driving interest from many industries.

Digital health will continue to be at the forefront to dominate private investments, political rhetoric, regulatory interest, and public conversations.

Big Data? A convenient way to share and transmit information internationally and instantaneously. Improvement in the functionality of the Internet would see the volume of data has increased due to data being readily available and processed from by many sources.

Cybersecurity Requirements? Our smartphones are getting more integrated into patient care planning, providing internet connectivity to share data with Healthcare Delivery Organizations (HDOs), doctors and researchers.

Chinese Medicine? Chinese medicinal herbs are now slowly getting integrated as new alternatives to treat febrile disease.

2020 would see a deeper exploration in advertising, promotion, and labeling in addition to the role of social media in regulatory communications.