Science-Led Regulatory Reform: Accelerating Biosimilar Development to Expand Patient Access to Life-Changing Medicines

Science-Led Regulatory Reform: Accelerating Biosimilar Development to Expand Patient Access to Life-Changing Medicines

Wednesday, October 29, 2025 10:00 AM to 10:30 AM · 30 min. (Africa/Abidjan)
Hall 12.1 - 12.1C68
Future of Pharma & Ingredients
ManufacturingSupply ChainSustainability

Information

How can streamlined regulation unlock access to biosimilar medicines and ease pressures on healthcare systems?

Regulatory harmonization and efficient development pathways are key to accelerating access to biosimilars. While biologics have transformed care for conditions like cancer and autoimmune diseases, their high cost can limit patient access. Biosimilars offer a more affordable alternative with the same efficacy, safety and quality, broadening treatment options and freeing up resources for patient care. Yet, barriers to access remain. This session explores how science-based regulatory reforms, such as waiving unnecessary comparative efficacy studies, can help speed up development across more therapeutic areas, and deliver greater value for patients globally..

Siegfried AGSiegfried is a preferred partner for complete integrated Drug Substance and Drug Product services with production capabilities worldwide. Creating, improving and manufacturing formulations is our passion. Our professionalism is pivotal for your project throughout the entire life cycle. Our offering, the combination of inherited technical know-how and expertise, is unique for a supplier of development and manufacturing services. Our Drug Substance services include Custom Development and Contract Manufacturing for both APIs and intermediates. In addition, we offer a multiclient API portfolio (including controlled substances) with drug master files and patented technologies. Our Drug Product clients benefit from a broad spectrum of dosage forms and technologies like oral solids, inhalative products, opthalmics and sterile ointments. Drug Product services include Custom Development and Contract Manufacturing for the dosage forms mentioned above. Siegfried enhanced its Drug Product capabilities with the acquisition of two Novartis sites near Barcelona and the establishment of a center of excellence for developing and optimizing formulations. Thus, we expanded our competency with high potent Drug Product development and manufacturing down to an OEL of 1Mug/m3, next to capsules with APIs (down to 0.1 Mug/m3). Complex oral drug delivery systems or solubility increasing of APIs (e.g. nanomilling or spray drying) belong to our core competences. In the field of steriles, we are experienced with fill and finish of vaccines and biologic compounds. Furthermore, we can offer dry powder inhalator capsules. Siegfried has 11 GMP approved sites worldwide spanning both the eastern and western hemispheres. Our Drug Substance sites are located in Zofingen (Switzerland), Pennsville (US), Nantong (China), Minden (Germany), Evionnaz (Switzerland) and St. Vulbas (France). Our Drug Product locations are in H...

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