Reports

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.

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

Home/Reports | Posted 04/09/2020

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

Home/Reports | Posted 28/08/2020

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

Home/Reports | Posted 31/07/2020

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

Home/Reports | Posted 24/07/2020

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

Home/Reports | Posted 17/07/2020

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

Home/Reports | Posted 10/07/2020

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

US biosimilars pipeline for growth hormone and infertility drugs

Home/Reports | Posted 03/07/2020

Global spending on medicines reached US$1 trillion in 2014 and was expected to rise to US$1.2 trillion by 2017 [1], with biologicals making up an increasing part of this total due to their use to treat previously intractable diseases. In fact, spending on biologicals has doubled since 2007 and growth has outstripped that of total sales of pharmaceuticals by a significant margin. 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 [2].

Analysis of biological sales for OECD countries

Home/Reports | Posted 03/07/2020

Data on biological sales for 2018 show that the US tops the list of Organisation for Economic Co-operation and Development (OECD) countries in terms of both per capita sales and share of sales. The data are provided by the Government of Canada in a May 2020 report and show that biologicals account for almost a third of total pharmaceutical sales in Canada.

US biosimilars pipeline for supportive care, oncology and TNF inhibitors

Home/Reports | Posted 26/06/2020

Biologicals represent many of the most promising new therapies for previously intractable diseases and are becoming increasingly important in the pharmaceuticals market. 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].

Trends in biological drugs in Canada

Home/Reports | Posted 26/06/2020

Information recently released in May 2020 by the Patented Medicine Prices Review Board (PMPRB) provides new detail on the Canadian biologicals market for 2018, including trends and international comparisons in sales, pricing and biosimilar uptake.

Approval and launch dates for US biosimilars

Home/Reports | Posted 19/06/2020

To date (19 June 2020), the US Food and Drug Administration (FDA) has approved 27 biosimilars, plus four follow-on biologicals [1]. The pipeline for biosimilars continues to grow, however, of the 27 biosimilars approved, only 17 have so far been launched [2].

Barriers to biosimilars access in the US

Home/Reports | Posted 29/05/2020

The US Food and Drug Administration (FDA) has approved 26 biosimilars [1], yet only two are available on the market. A recent exploration [2] of this issue highlights the major obstacles to biosimilar access in the US.

GBMA publishes quarterly review of biosimilar literature

Home/Reports | Posted 15/05/2020

The Generic and Biosimilar Medicines Association (GBMA), which is the representative body of generic and biosimilar medicine suppliers in Australia, has released its quarterly review of biosimilar literature [1].

Biosimilars could have saved US companies US$1.4 billion in 2018

Home/Reports | Posted 04/05/2020

Increasing the use of biosimilar could have saved self-insured companies in the US up to US$1.4 billion on just two biologicals – infliximab and filgrastim – during 2018.

Market for copy biologicals in ASEAN and China expected to grow

Home/Reports | Posted 24/04/2020

The Association of Southeast Asian Nations (ASEAN) and China market for copy biologicals was valued at US687.6 million in 2017 and is expected to reach US$5.5 billion by 2025 with a compound annual growth rate (CAGR) of 29.7%, according to a new report by Allied Market Research.

Use of biosimilars for chronic inflammatory diseases in Canada

Home/Reports | Posted 20/03/2020

The high cost of originator biologicals in Canada has created a demand for biosimilars as a way of reining in costs for Canadian public healthcare payers. However, although several biosimilars are now commercially available in the country for a variety of conditions [1]; it has been suggested that the uptake of biosimilars in Canada remains low [2].

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