US biosimilars pipeline for supportive care, oncology and TNF inhibitors – 2021

Home/Reports | Posted 14/05/2021

Biologicals represent many of the most promising new therapies for previously intractable diseases and are becoming increasingly important in the pharmaceuticals market. The global biologicals market in 2020 was worth approximately US$239.2 billion, and in 2020 five of the top 10 best-selling drugs were biologicals compared with a high of seven in 2018, and only three in 2008 [1].

Biosimilars market and opportunities in Europe

Home/Reports | Posted 17/05/2019

How the biosimilars market in Europe has changed and what opportunities for biosimilars exist for the near term in the region is being reviewed by Murray Aitken in this article [1].

Approval and launch dates for US biosimilars – 2021

Home/Reports | Posted 07/05/2021

To date (7 May 2021), the US Food and Drug Administration (FDA) has approved 29 biosimilars, plus four follow-on biologicals [1]. The pipeline for biosimilars continues to grow, however, of the 29 biosimilars approved, only 20 have so far been launched [2].

The future of copy biologicals in China

Home/Reports | Posted 30/04/2021

Between 2013 and 2017 the market for biologicals in China almost tripled. According to law firm Hogan Lovells, the market for biologicals was expected to grow at a compound annual growth rate (CAGR) of 17% through 2022, with most of this expansion coming from monoclonal antibodies (mAbs), which are expected to grow at a CAGR of over 40% through 2022. However, according to new reports, the market has already grown three-fold between 2017 and 2021 and could grow five-fold over the next 10 years.

Challenges facing copy biologicals in China

Home/Reports | Posted 23/04/2021

There are many challenges still facing Chinese companies when it comes to getting copy biologicals onto the market. Such challenges include creating a strong manufacturing and distribution infrastructure, which is essential for the successful launch of copy biologicals.

Investment increasing pipeline of copy biologicals in China

Home/Reports | Posted 16/04/2021

Investment in research and development for copy biologicals is producing an extensive pipeline of products in China.

Improved regulation favouring copy biologicals in China

Home/Reports | Posted 09/04/2021

Europe’s drug regulator, the European Medicines Agency (EMA) was the first agency around the world to establish regulatory guidelines for biosimilars back in 2005 [1]. This more favourable regulatory environment has enabled Europe to lead the way in the adoption of biosimilars. In fact, Northern Europe has world leading biosimilar adoption rates, helped by its local tendering systems and national policies encouraging physician-led switching [2].

Patent expiries may drive development of copy biologicals in China

Home/Reports | Posted 02/04/2021

The number of patents expiring on blockbuster biologicals may drive growth in the market for copy biologicals in China.

Cancer driving the need for copy biologicals in China

Home/Reports | Posted 26/03/2021

Cancer is the leading cause of death in China and in 2018 the country represented 24% of all cancer incidences and 29-45% of the world’s total for colon, liver, lung, oesophagus and stomach cancers, see Figure 1.

Drug regulators need to evolve with biosimilars

Home/Reports | Posted 26/03/2021

A report produced for the Biosimilars Council highlights the importance that drug regulators are willing to evolve when it comes to biosimilars [1].