Reports
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].
Targets and incentives to encourage use of biosimilars
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
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
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?
Authors discuss how the biosimilar markets in the US and Europe compare in a report produced for the Biosimilars Council [1].
What can the US learn from the European biosimilars market?
In a report produced for the Biosimilars Council, which is a division of the Association for Accessible Medicines (AAM), authors discuss the lessons that the US might learn from the European experience with biosimilars [1].
FDA publishes report on areas of regulatory focus for 2021
The US Food and Drug Administration (FDA) announced on 11 January 2021 that it had published its Focus Areas of Regulatory Science (FARS) report. One of the areas of focus identified by the report is increasing access to generic alternatives for complex drugs.
