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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

1 However, as most biosimilars are developed by means of a complex biotechnological process in living organisms, this inevitably leads to differences between the biosimilar and the reference product. Marie Manley leads Sidley’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law.

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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. The work, said lead investigator Brett King, Associate Professor at Yale Dermatology, “helped change the landscape of alopecia areata forever.”. 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. The work, said lead investigator Brett King, Associate Professor at Yale Dermatology, “helped change the landscape of alopecia areata forever.”

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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. he is responsible for leading the commercialization efforts of specialty products which includes a broad portfolio of biosimilars. Now, as the President of Accord BioPharma , the U.S. Look, competition is healthy.

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Drug pricing increases are disgraceful

World of DTC Marketing

In November 2017, a study published in JAMA Internal Medicine examined the costs of developing 10 cancer drugs approved by the FDA from 2006 to 2015 and provided a strong contrast to the Tufts study from a year before. After all, 90 percent of all drugs that enter human testing fail. Drug companies are wasting huge amounts of money.

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Comparison of Humira biosimilars in the US and Europe

Pharmaceutical Technology

Currently, 40 biosimilars are FDA-approved and 25 have launched, whereas the EMA has approved 86 biosimilars since 2006. Many experts have concerns that only a few Humira biosimilars will have access to the US market, while the rest will not be listed, thereby leading to lower savings than expected.

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

pharmaphorum

For instance, in pharmaceutical manufacturing, mistakes in training can lead to contamination or waste, which can cause businesses unnecessary headaches. In addition, she worked as head of inspectorate and licensing for the MHRA from 2004-2006. She joined NSF in 2017. appeared first on.