Reports
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.
FDA includes generics of complex drugs in regulatory focus
One of the areas of focus identified in a new report issued by the US Food and Drug Administration (FDA) is increasing access to generic alternatives for complex drugs.
Biosimilars policy considerations in the US
When it comes to policy considerations, the new product entrants always face considerable challenges. Recent legislation and regulation intend to level the playing field and create fair competition for biosimilars to allow for their growth. However, some have been designed to favour biosimilars. In light of this, the report highlights the Prescription Drug Pricing Reduction Act of 2019 (currently stalled) that will allow providers to get higher levels of reimbursement for biosimilars than for reference products.
US biosimilars reimbursement: Medicare and 340B
2020 sees the publication of the seventh edition of Biosimilars Trend Report. This describes the landscape for biosimilars in the US in 2020, with an update on the Medicare and 340B programme.
