SomaLogic And FDA Will Streamline Biosimilar Development
Agreement Aims To Identify Pharmacodynamic Biomarkers For Reference Biologics
Further to the US Food and Drug Administration’s own plans to develop a framework to further the use of pharmacodynamic biomarkers and potentially streamline biosimilar development, the FDA has joined forces with US-based specialist SomaLogic, gaining access to its proprietary technology platform.
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Finance Watch: Biopharma VC Explosion Extends To Tools, Services
Private Company Edition: Venture capital financings didn’t take a break during Thanksgiving week. In addition to the $800m Resilience raised to fund manufacturing services, SomaLogic closed a $121m series A round to fund its proteomic tools for drug discovery and diagnostics development.
UK Lays Out Reduced-Data Pathway For Biosimilars
The UK’s MHRA has laid out its plans for a biosimilar licensing pathway that will typically not require comparative efficacy data and will consider approved biosimilars interchangeable with their reference products for all indications. Local industry believes the guideline creates an opportunity for the UK to be the first launch market for biosimilars.
IGBA Calls For ‘Streamlining’ Of Global Biosimilars Process
The IGBA has called for a “streamlined” global biosimilar development and registration process, with a new policy paper highlighting the limited value of comparative efficacy clinical data at the same time as it urges renewed efforts on educating healthcare professionals.