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The Evolution of Biosimilars from Their Beginning Until Now—And What’s Next

PM360

Chrys Kokino has been involved in the biosimilars market prior to the first biosimilar being approved in Europe in 2006. Now, as the President of Accord BioPharma , the U.S. From that point in 2006 all the way to where we are currently today, there has been a very dramatic evolution of these products.

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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. For this reason, a unique ‘abridged’ procedure was introduced to provide a specific regulatory pathway for biosimilars in the EU.

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How can the pharma industry address the gap in talent recruitment and development?

pharmaphorum

This is due to the specialist nature of roles and the growth and diversification of biopharma, which requires an increasingly sophisticated and skilled workforce. In addition, she worked as head of inspectorate and licensing for the MHRA from 2004-2006. Training and development. She joined NSF in 2017. appeared first on.

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Bringing the patient voice into clinical trials with clinical outcome assessments

Clarivate

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. In this article, we share how a sponsor partnered with Clarivate to incorporate COAs into clinical trials for alopecia areata. The regulatory landscape around COAs is fast evolving.

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How clinical outcome assessments can help us understand the patient experience

Clarivate

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. Data and insights gleaned from these projects have most recently been presented at industry conferences and events, including ISPOR.

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The Biotech Effect

Pharmaceutical Technology

“The inherent advantages of biopharma are that it allows you to pursue therapies against targets that are not small molecule therapies, for example by targeting protein-protein interactions and targeting GPCRs (G-protein coupled receptors),” he says. “Biotechnology has exploded across the industry. .”