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Establishing interchangeability for biosimilars

Hans Ebbers, Regulatory Project Leader of the Pharmacotherapeutic Group III at the Medicines Evaluation Board (MEB/CBG) in The Netherlands discussed how to establish interchangeability at the European Commission Stakeholder Event on Biosimilar Medicinal Products, which was held in Brussels, Belgium on 5 May 2017.

Is a biosimilar forever or just for Christmas?

Dr Elena Wolff-Holz discussed the need for clinical studies and the evolution of biosimilars over time. During her keynote address at the biosimilar medicines conference in London, UK, Dr Wolff-Holz highlighted that the ‘need for clinical studies may depend on the size and complexity of the biological and the clinical indications sought. Some examples of this include:

The importance of EPARs

Dr Elena Wolff-Holz* discussed the importance of European public assessment reports (EPARs) at a major biosimilar medicines conference in London, UK [1].

Biosimilars in the European Union

Dr Elena Wolff-Holz gave a keynote address at Medicines for Europe’s 15th Biosimilar Medicines Conference: Biosimilar Medicines: A game changer for healthcare sustainability [1].

Switching approaches to biosimilars in Nordic countries

In the European Union (EU), decisions on the interchangeability or substitution of biosimilars and originator biologicals are not made by the European Medicines Agency (EMA), but at the national level. This is despite the fact that biosimilars developed in line with EU requirements are considered by EMA to be therapeutic alternatives to their reference biologicals.

The evolution of switching and substitution of biosimilars in Europe

Switching patients from originator biologicals is often an emotive subject. However, despite reservations by prescribers and payers alike the tide may be finally turning, with Scandinavian countries leading the way [1].

Recommendations for the use of biosimilars in rheumatic diseases

Biological therapies have become a central part of the long-term management of many chronic diseases, including inflammatory rheumatic diseases.

Competition lacking in the Mexican drug market

A report by the Mexican antitrust commission COFECE – Comisión Federal de Competencia Económica finds that off-patent drugs are not generating sufficient competition against the major pharmaceutical companies, which continue to dominate the market.

Regulatory pathways for approval of biological products in Brazil

Up until 2002, Brazil had no specific guidance for biological products. In 2002 guidelines for biological products were published (RDC 80/2002), which had to be followed by both originator biologicals and ‘follow-on biological products’.

Regulation of follow-on biological products in Brazil

The regulatory body for approval of medicines in Brazil is the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) [1]. The agency was created by Law 9782, which was enacted in 1999 [2]. Since then, numerous guidance for biologicals and follow-on biological products have been issued by ANVISA, see Figure 1.

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