Reports

Biosimilars trend report 2020

Home/Reports | Posted 20/11/2020

The seventh edition of the Biosimilars Trend Report 2020 has been published. This 2020 report was developed based on input from members of the healthcare community in the US [1].

Smart healthcare spending and the Falsified Medicines Directive in Europe

Home/Reports | Posted 06/11/2020

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a white paper on ‘Strengthening health systems through smart spending’ and a ‘Benefits beyond the EU Falsified Medicines Directive - The hospital setting’ report.

Challenges faced by biosimilar orphan drugs in European health systems

Home/Reports | Posted 30/10/2020

As treatments for rare diseases become a greater healthcare priority, the contribution of biosimilars as a means of reducing costs and increasing patient access will become more important for the long-term sustainability of health systems [1]. While the current impact of non-orphan biosimilars suggests this contribution could be significant, uptake of biosimilars across Europe remains variable and there is a risk that sustainable competitive markets are not yet established. A recent review of biosimilar policies in Europe found that key principles for a sustainable biosimilar market include supporting innovation, physician prescribing freedom, and allowing for multiple suppliers [2].

Commercialization challenges for biosimilar orphan drugs

Home/Reports | Posted 23/10/2020

Companies seeking to commercialize orphan drug biosimilars are likely to face challenges associated with limited potential market size, uncertainty regarding expanding patient access and loyalty to the reference product.

Clinical development challenges faced by orphan drug biosimilar developers

Home/Reports | Posted 16/10/2020

Biosimilar development is more costly and requires greater effort to conduct analytical and clinical testing than generic drug development. These challenges can be amplified when developing a biosimilar of an orphan drug.

The landscape for orphan drugs in Europe

Home/Reports | Posted 09/10/2020

The discovery and development of medical products for the prevention, diagnosis and treatment of rare diseases has been a public health priority in Europe for several decades [1]. Rare diseases in this context are defined as chronically debilitating or life-threatening conditions that affect fewer than five in 10,000 people within a given community, or diseases which are unlikely to generate a sufficient return on investment for developers without incentives.

Generics and biosimilars can save Ireland Euros 1 billion in five years

Home/Reports | Posted 09/10/2020

Medicines for Ireland (MFI) launched their ‘Reductions in the Cost of Medicines – Ireland’s Patients First 2020–2022’ report on 29 September 2020. This report outlines how additional savings of up to Euros 1 billion in the next five years can be achieved through increased use of generics and biosimilars.