news
Sandoz breaks ground on new European biosimilar plant
The new investment will help Sandoz to expand its European biosimilar manufacturing capacity and ensure reliable and sustainable supply in the region.
List view / Grid view
Biosimilars
article
Bioprocessing / Bioproduction In-Depth Focus 2025
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.
article
New biosimilar pathways – key takeaways from the EMA’s draft reflection paper
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.
news
R&D and tech innovation boosting biopharmaceutical market to 2030
Advanced technology innovation is driving lower R&D costs and progress of targeted treatments such as cell and gene therapies, the research reports.
news
CHMP meeting highlights – May 2025
The EMA’s committee has granted positive opinions for ten new treatments, including medicines for oncology indications and rare diseases.
news
CHMP meeting highlights – April 2025
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.
news
EMA proposes streamlined approach for biosimilar development
In certain cases, analytical comparability exercises and PK data could be sufficient for demonstrating biosimilarity, the EMA highlights in its new paper.
news
Tariffs could threaten medicine innovation, industry bodies warn
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.
article
Biosimilar medicines: the intersection of access, affordability, and innovation
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.
webinar
When innovative formulations cloud sterility testing
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.
article
Pharma Horizons: Biologics
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key developments in pharmaceutical biologics for drug development, pharmaceutical manufacturing and quality control.
news
CHMP meeting highlights – June 2024
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.
webinar
Enhancing oral drug delivery: Exploring multiparticulate systems
11 June 2024 | By ThermoFisher Scientific
Explores the benefits and uses of multiparticulate systems in oral drug delivery and how they can help address challenges faced by traditional dosage forms.
news
Two novel biosimilars approved in EU and US
The first omalizumab biosimilar in allergic diseases is approved by the European Commission and the US Food and Drug Administration (FDA) has authorised the fifty third biosimilar in the US.
news
Improving accuracy of spectroscopy for protein analysis
A study on spectroscopy challenges during biosimilar analysis has highlighted a novel observation with potential implications for quality control when detecting protein structures.
