Wednesday, January 30, 2019 Daily Archives

Biosimilars: Challenging the Justifications for Clinical Testing

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The Biologics Price Competition and Innovation Act (BPIA) of 2009, describes the need for clinical trials as follows (1): “(cc) a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product.†However, all the above studies are left…

January 30, 2019

Trends in Real-World Study Design and Postmarketing Commitments in the EU and US: What We Can Learn from Big Data

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When a new medicine is approved, there is under a 25% chance that the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA) will impose, as part of conditional approval, studies conducted to satisfy postmarketing requirements. US regulations governing such studies are found in the 2011 guidance document regarding “Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (1).†EMA regulations are found in the 2017 “Guideline…

January 30, 2019

Life after Lonza: Sartorius looks to build inhouse culture media biz

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After a six-year partnership with CDMO Lonza ended, Sartorius Stedim Biotech says it is looking to build its own cell culture media business. In November 2018, bioprocessing vendor Sartorius and contract development and manufacturing organization (CDMO) Lonza ended a supply and distribution partnership forged in December 2012 for media and buffers used in the manufacture of protein-based therapeutics and vaccines. Under terms of the deal, Lonza manufactured the media and Sartorius had the exclusive sales and marketing rights. Customers of…

January 30, 2019

Finding closure: Lowering the costs of cell and gene therapies

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Fully closed and automated platforms are key to reducing the current high costs of cell and gene therapy manufacturing, say industry experts. Cell and gene therapies (CGTs) have come a long way over the past two years, resulting in two chimeric antigen receptor (CAR) T-cell therapies – Kymriah and Yescarta – and the novel gene therapy Luxturna reaching commercialization. But now these therapies have proved themselves, the major talking point among delegates at the Phacilitate conference in Miami, Florida last…

January 30, 2019

Amgen completes five-year plan, sees 24% drop in facility footprint

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Amgen’s commitment to next generation biomanufacturing has led to a reduction in its facility footprint of nearly a quarter since 2013. In 2013, Amgen commenced a “company-wide re-engineering process†aimed at transforming its business to prepare for long-term growth. The restructure included significant job cuts and plans to reduce facility footprint by 23%, while ensuring increased bulk production through next-generation biomanufacturing platforms. Five years on, and David Meline, Amgen’s CFO, said the firm has successfully transformed “the business “to achieve…

January 30, 2019