Reports

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].

The state of play for copy biologicals in China

Home/Reports | Posted 19/03/2021

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

Home/Reports | Posted 19/03/2021

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].

Targets and incentives to encourage use of biosimilars

Home/Reports | Posted 12/03/2021

How to increase the uptake of biosimilars is an important issue in both Europe and the US and was discussed in a report produced for the Biosimilars Council [1].

Education for biosimilars in Europe and the US

Home/Reports | Posted 05/03/2021

Education on biosimilars for both prescribers and patients is an area that has received focus in both Europe and the US according to a report produced for the Biosimilars Council [1].

Price controls, competition and tendering for biosimilars

Home/Reports | Posted 26/02/2021

What lessons the US can learn from price controls, competition and tendering for biosimilars in Europe was a topic discussed in a report produced for the Biosimilars Council [1].

How do the biosimilar markets in the US and Europe compare?

Home/Reports | Posted 19/02/2021

Authors discuss how the biosimilar markets in the US and Europe compare in a report produced for the Biosimilars Council [1].