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In this article, Michal Nitka, Senior Vice President, Head of Generics Europe & Global Head OTC, Teva Pharmaceuticals, outlines how policy reform, digital innovation, and manufacturing resilience can secure sustainable access to essential treatments - ensuring generic medicines remain a cornerstone of equitable, reliable care.
The proposed transaction means Just-Evotec Biologics’ Toulouse site would be used to develop and manufacture Sandoz biosimilars.
While the pharmaceutical market is expected to witness strong pricing competition, there is also significant opportunity for biotech companies, research says.
The new investment will help Sandoz to expand its European biosimilar manufacturing capacity and ensure reliable and sustainable supply in the region.
This in-depth focus features articles on biosimilars and biomanufacturing in Europe, the potential of plant tissue-based bioproduction and utilising digital twins for optimisation of bioprocesses.
Here, Vladimir Murovec, Counsel, Osborne Clarke, discusses the European Medicines Agency (EMA)’s latest draft reflection paper and its scientific rationale, regulatory implications and potential impact on biosimilar drug development and manufacturing in the EU.
Advanced technology innovation is driving lower R&D costs and progress of targeted treatments such as cell and gene therapies, the research reports.
The EMA’s committee has granted positive opinions for ten new treatments, including medicines for oncology indications and rare diseases.
The Committee for Medicinal Products for Human Use (CHMP) recommended approval of a variety of new medicines, including several treatments for hereditary and rare conditions.
In certain cases, analytical comparability exercises and PK data could be sufficient for demonstrating biosimilarity, the EMA highlights in its new paper.
Biotechnology Innovation Organization (BIO) and the International Generic and Biosimilar medicines Association (IGBA) highlight the need for industry cooperation to support the potential impact of tarrifs.
In this article, Julie Maréchal-Jamil, Director, Biosimilar Policy & Science, Medicines for Europe, explores the strategies needed at European and national levels to secure the benefits of biosimilar medicines in an evolving landscape to deliver a pipeline for these drugs by 2030.
30 October 2024 | By Charles River
Webinar presented by Miriam Guest, Senior Principal Scientific Advisor at Charles River, to explore how ATP-bioluminescence outperforms traditional sterility testing in complex matrices.
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key developments in pharmaceutical biologics for drug development, pharmaceutical manufacturing and quality control.
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended several new medicines, including positive opinions for treatments for rare disorders.
