FDA’s Post

20 year's experience has generated strong scientific support for interchangeability of biosimilars approved according to standards set by major regulatory authorities such as #FDA and #ema. This statement from US-FDA is fully aligned with our statement from April 2023 (https://lnkd.in/d9Fkqmk5) underpinning that biosimilars offers an alternative that are equally safe and effective as their reference counterparts

CDER’s recent research takes the Spotlight! 🌟 Check out the latest Spotlight on CDER Science, which highlights research that examined the safety aspects of switching between reference #biologics and #biosimilars: https://lnkd.in/d2s2EtHU

2024 has started and there are many biosimilars being covered that may not have been covered before on your formulary- if you have worried about switching between a biosimilar and the reference product, then check out this article that highlights research conducted by FDA staff. The bottom line: In the meta-analyses, the researchers found zero difference in the risk of death, serious adverse events, and treatment discontinuations between participants who switched between biosimilars and reference products and participants who did not switch.

Scale up your industry knowledge at the European Biomanufacturing Summit on 10-11 September 2024 in Berlin, Germany. Immerse yourself with over 120 biomanufacturing experts in lively discussions on biomanufacturing #cellandgene #biologics and #biosimilars, along with many other core discussions in the industry. Stay at the forefront of industry trends and connect with top innovators in the #biomanufacturing industry https://hubs.ly/Q02C1N8k0 #BioEU24 #GenerisBIOEU

Science Fiction TRIPLE Feature! I've got three fantastic new application notes on the use of sub-cellular fractions for #ADC's! In the first we can see how you're toxin stands up inside lysosomes to ensure it isn't degrading before it can show activity. Next we look at your toxin linker ensuring it cleaves in an effective time frame and into the right released warhead. And finally we take the full ADC into your lysosomal fraction to measure the release of your toxin. Check them out at the links in the comments >>> Lots of fantastic new applications here at #Sterling! #Biologics #MassSpectrometry #ADC

Let me know if you plan to attend any of these conferences and would like to connect and learn more about how Solvias can support your analytical testing needs.

Join our Expert trainer Kjell Eriksson on our 3-day course that describes how to develop downstream processes for biologicals. From the use of individual unit operation to developing economical, robust and scalable processes. State of the art techniques with a risk-based approach and using a Quality by Design methodology are discussed. The topic of comparability in scale up and for biosimilars are discussed. #biologics #biosimilars #symmetrictrainings

You are invited to Join the webinar run by RhinoEgypt experts. " Recent Advance in Chronic Rhinosinusitis With Nasal Polyps For Daily Practice" “CRSwNP” Friday 26, 2024 Join us virtually on zoom: https://lnkd.in/dZnnq-st #CRSwNP #rhinoegypt #nasal_polyps #sinusitis #polyps #fess #EESS #biologics

Have you ever SEEN an antibody-drug conjugate (ADC) dissolve? At The Solubility Company this is what we see every day. Want to learn more? Don't miss our next Newsletter on ADC solubility measurement coming on August 12th! Subscribe here https://lnkd.in/duPzEuWp #ADC #innovation #newmodalities #bioconjugation #antibodydiscovery #biomanufacturing #biopharma #biologics #bio #solubility #drugdiscovery #drugdevelopment

It's a first for us to be able to share this visualisation of an ADC dissolving, thanks to Kirsi Bau-Adler and Sami Svanbäck for making it happen. The 2nd second most popular question we get asked is 'can we see how my API dissolves in the the SPA™ Assay?' , now the answer is YES! Bonus points if you can guess the most asked question :) #drugdiscovery #drugdevelopment #solubility #datainnovation #TheSolubilityCompany