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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.
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Biosimilars
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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.
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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.
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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.
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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.
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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.
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CHMP meeting highlights: April 2024
In its April meeting, the EMA’s human medicines committee recommended eight new medicines, including treatments for cancer and autoimmune diseases.
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Bioprocessing / Bioproduction In-Depth Focus 2024
This in-depth focus features articles on bioreactor size, as well as bioprocess development and manufacturing of bioconjugated products.
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European Commission authorises one of first ustekinumab biosimilars in Europe
This approval follows a development and commercialisation agreement made in September 2023 between Sandoz and Samsung Bioepis for the biosimilar ustekinumab.
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Teva enters into oncology biosimilar licensing agreement
The agreement between Teva and mAbxience for the oncology biosimilar candidate will help to reduce costs within healthcare.
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Patent expiration to drive biosimilars market expansion to 2032
Cost effectivity of biosimilars is predicted to be a key contributor to growth of the global biosimilar market to 2032, research states.
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Sandoz granted novel biosimilars approval
The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
