Sponsor Overview
Explore verified public information about Swedish Orphan Biovitrum AB's expanded access programs, compassionate use policies, and patient eligibility pathways. This report aggregates official statements, independent research, and regulatory data to help patients, providers, and sponsors collaborate efficiently.
Unique references curated across 2 content categories.
ClinicalTrials.gov data sources power this status.
Dataset refreshed continuously through Right2Hope ETL pipelines.
Expanded Access Intelligence
Official Statements
Score contribution: 100 — 5 supporting sources.
“Sobi has a process in place, referred to as “Managed Access Programmes” through which certain treatments can be made available to eligible patients, provided specific criteria and requirements are met.”
“Welcome to Sobi's Managed Access Portal. Here you can submit a new request or log into your existing account to view previous requests and apply for resupply of a product.”
“Sobi har inrättat en process, ”Managed Access Programmes”, genom vilken vissa behandlingar kan göras tillgängliga för dessa patienter, förutsatt att specifika kriterier och krav uppfylls.”
“Our growth and expansion strategy helps bring medicines to new markets and adds indications, which allows more patients to access medicine. We also have a partnership strategy to serve currently underserved markets.”
“In some countries, Sobi has managed access programmes for people living with life-threatening diseases with no other option available. Sobi has an established process for emergency orders within the EU and the US for life-saving medicines, which are also available during non-office hours 365 days a year for immediate service if needed to save a person’s life.”
Reagan-Udall Foundation Insights
Single-Patient EA Policies/Criteria Sobi may make an investigational medicine available if the following eligibility criteria and additional requirements are met: § The patient has a serious or life-threatening disease without a satisfactory alternative therapy or treatment and an unsolicited Managed Access request has been submitted to Sobi by the treating physician § The patient is not eligible or able to enter an ongoing clinical trial § There is sufficient data to indicate that the benefit of the investigational medicine outweighs the potential risks in the context of the disease or condition being treated § There is a sufficient supply of the investigational medicine available and providing the medicine will not interfere with ongoing clinical studies or other development activities § The patient meets any eligibility criteria set by Sobi’s Medical Committee evaluating Managed Access requests § Laws and regulations in the country of request allow Managed Access
Partner with Right2Hope
Right2Hope helps sponsors translate regulatory programs into actionable patient access pathways. Connect with our team to publish new programs, streamline intake workflows, or align with providers seeking compassionate use options.