Reports
Approval and launch dates for US biosimilars – 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
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
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
Investment in research and development for copy biologicals is producing an extensive pipeline of products in China.
Improved regulation favouring copy biologicals in China
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
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
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
A report produced for the Biosimilars Council highlights the importance that drug regulators are willing to evolve when it comes to biosimilars [1].
The state of play for copy biologicals in China
China released finalized technical guidance for the development and evaluation of copy biologicals in February 2015 [1]. To date, China’s drug regulator, the National Medical Products Administration (NMPA), has approved 12 copy biologicals for use in China [2].
Confidence in clinical evidence and switching data for biosimilars
Switching patients from originator biologicals is often an emotive subject. Therefore, increasing confidence in the safety of switching between reference products and biosimilars is an important subject for both Europe and the US, and was a subject discussed in a report produced for the Biosimilars Council [1].
