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Commercialization challenges for biosimilar orphan drugs

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

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

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

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.

Biosimilar infliximab could save Canada over CA$2 million by 2021

Estimates for the potential savings from the use of infliximab biosimilars in Canada suggests that savings by 2021 could be between CA$447 million and CA$2,310 million, depending on the level of uptake.

Cost savings from biosimilars in Canada: actual and projected

Information from the Patented Medicine Prices Review Board (PMPRB) in Canada details the cost savings that could be made from biosimilars in the country.

Biosimilar infliximab uptake in Canada

The first biosimilar infliximab was sold in Canada in 2015, yet by 2018 uptake was still less then 10%, data from the Patented Medicine Prices Review Board (PMPRB) reveal.

Low levels of biosimilar uptake in Canada

Data from Canada’s Patented Medicine Prices Review Board (PMRPB) reveal an increasing number of biosimilar approvals in recent years, yet Canada lags behind other nations in terms of both approvals and uptake.

US biosimilars pipeline for immunosuppressants, insulin and ophthalmology

Biologicals are becoming increasingly important in the pharmaceuticals market due to their use to treat previously intractable diseases. The global biological market is worth approximately US$276 billion, and in 2018 seven of the top 10 best-selling drugs were biologicals compared with only three in 2008 [1].

The cost of biologicals in Canada

The top 10 selling originator biological drugs accounted for over half of all biological sales in Canada in 2018, new data reveal.