Member Spotlight / News - January 25, 2023

EUCOPE Member Spotlight: Q&A with Sobi – Swedish Orphan Biovitrum

Every month, EUCOPE spotlights a member company and the great work they’re doing to advance the life sciences industry and drive innovation to serve patients better. In January, we spoke with Jameel Nazir, Vice President Patient Access and Community Engagement at Sobi – Swedish Orphan Biovitrum AB.

​​​​​​Dr Jameel Nazir is currently serving as Vice President Patient Access and Community Engagement (PACE) at Swedish Orphan Biovitrum AB (Sobi) where he is responsible for managing global Access strategies and policy initiatives, HEOR strategies and real-world evidence generation to support health technology assessments across the globe.  He has a Bachelor of Science degree in Pharmacology from University College London (UCL), an MSc in Health Economics from City University of London and a PhD in Health Economics from Manchester Metropolitan University (MMU). Prior to taking on his role at SOBI, Dr Nazir gained experience in Health Economics and Outcomes research in various global and regional roles at Astellas Pharma, Smith & Nephew and Janssen Cilag Ltd (J &J).


 Tell us about your organisation and its mission and how you drive innovation internally?

Sobi is an international biopharmaceutical company, headquartered in Stockholm, Sweden. Since 1931 (originally under the name of Kabi) Sobi has been delivering innovative therapies to patients across the world in the areas of Haematology and Immunology, and the overlap between them. Across the entire value chain, Sobi works in close dialogue with all stakeholders from healthcare professionals, patient organisations, government authorities, regulatory bodies, payers and business partners in developing and providing treatments that transform the lives of people living with rare diseases. We see partnerships as essential in our efforts to build and expand our clinical pipeline into new indications and therapeutic areas. Just before Christmas 2022, Sobi and ADC Therapeutics SA proudly announced that the European Commission has granted conditional marketing authorisation for Zynlonta® (loncastuximab tesirine). Zylonta is used for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), which is an aggressive and malignant haematological disease with an incidence in Europe of approximately 8.8 cases per 100,000 adults per year.

How do your organisation’s activities help patients now and into the future?

Many people living with a rare disease undergo a tremendous journey to receive a diagnosis and 95% of of rare diseases still have no approved treatment. Each 1600 employee who works for Sobi knows this reality very well, which in my view, motivates them to research and develop every day with passion new treatments which help address the unmet medical needs of people living with a rare disease and most of all ensure patients have timely and sustainable access to our medicines now and in the future.

To name some our activities which help patients: for example, to improve the level of care in developing countries, Sobi and Sanofi have donated their haemophilia medicines to the WFH Humanitarian Aid Program since 2015, which makes it possible for people with inherited bleeding disorders to receive consistent and reliable access to treatment and care. In 2021, the WFH celebrated reaching the milestone of 1B International Units (IU) of factor being donated through the Program, of which close to 600 million IUs of factor had been donated by Sobi and Sanofi and treating over 18,880 people globally.

Furthermore, Sobi together with our collaborators, patients and their caregivers, researched and developed in a record time a new treatment of coronavirus disease 2019 (COVID-19) for hospitalised adult patients with pneumonia who are at risk of progressing to severe respiratory failure.

Finally, Sobi recognises the importance of integrating the patient voice into R&D and clinical studies to ensure that future medicines adhere to patient needs and that the patient community is consulted in the early stages of clinical development. Sobi co-develops patient support programmes, advocacy and evidence generation activities with patient advocacy groups in rare disease areas such as Haemophilia, ITP, PNH, HLH, FMF, AKU and refractory gout.

What do you see as the biggest challenge facing the life sciences industry today and in the future?

Sobi is a company which over many years has specialised in researching and developing rare diseases therapies and our efforts are focused on making sure that there are more future treatments available to serve the unmet medical needs of people living with a rare disease. The COVID-19 pandemic, the war in Ukraine, high inflation and the increase in public debt, are serious challenges to the life science industry. We are already witnessing a gradual disinvestment in healthcare and access to new rare disease therapies will be a struggle. Furthermore, the evidence requirements for rare disease therapies are already becoming more stringent and this will impact the accessibility and availability of new treatments across European countries.

We have reached a crossroads where we need visionary, long-term change if we want to make a positive impact on the future of the rare disease community:

  • We need an environment which fosters rare disease innovation in Europe, through a thoughtfully calibrated incentive design and alignment of evidentiary requirements across the medicine lifecycle. Curtailing existing incentives such as market exclusivity will jeopardise long term research & development programmes.
  • Governments need to establish new pricing policies which consider the long-term value of the therapies, not just the cost, for example through amortisation payment models or outcomes-based agreements.
  • The framework and requirements for collecting and analysing real-world evidence (RWE) need to become more transparent and formalised in the decision-making process. Health Technology Bodies (HTAb) cannot use RWE just to point out the limitations and ignore the benefits in their assessments.

What are the major health policy issues and themes that you are most focused on in 2023?

The pharmaceutical landscape is constantly evolving but now more than ever governments are deprioritising healthcare, thus putting additional pressure on access and on the rare disease community, where their needs are already high and unmet. We need public policy reforms which encourage companies to bring more rare diseases therapies in a predictable environment, which helps alleviate research uncertainties and long-term investment risks.

As a European company, the Review of the EU Orphan Medicinal Products and Paediatric Regulation (EU OMP) is one of the most important health policy issues for Sobi. Sobi’s Global Access & Policy team has been closely working with EUCOPE and other industry partners to voice our concerns if OMP incentives are to be reduced or modulated with unsustainable requirements, as the European Commission is envisioning. There are many good policy counterproposals from the industry which the European Commission should consider in their draft proposal.

Another key policy priority for Sobi is the EU HTA Regulation. Sobi´s global access & policy team partnered closely with EUCOPE to provide input to several key EUnetHTA methodologies, especially to reflect the clinical realities of rare disease therapies. It remains to be seen if the vision of streamlining national HTA requirements, especially the clinical aspects, and the elimination of duplication will happen sooner rather than later. Simultaneously other national HTA reforms keep us awake at night, such as the one in Germany, whereby the reduction of the free pricing period and the lowering the orphan drug threshold will impact other markets which reference Germany in their pricing lists.

What attracted you to join EUCOPE and how can we help you achieve your business goals?

As a long-time EUCOPE member, we consider this organisation to be among the few European trade associations which are 100% committed to represent the voices of small to mid-sized companies working in the field of rare diseases. Many of the working groups which EUCOPE has created, such as the Incentives Steering Group (ISG) or the EU HTA Task Force are led by professional and dedicated EUCOPE employees which make the work pleasant and the deliverables impactful. As we are approaching the next legislative stages for the EU OMP Regulation, General Pharmaceutical Legislation and EU HTA, EUCOPE needs to stay focused and ensure clear coordination of deliverables among the members, i.e. timely responses to consultations, political engagements and coordination with other pharmaceutical trade associations where necessary.

For more information about EUCOPE membership

Visit our Benefits of Membership Page, or schedule an introductory call with our Business Development Manager Dante Di Iulio