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US biosimilars pipeline for growth hormone and infertility drugs

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

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

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

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

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

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

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

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

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

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].