Biosimilars/General

Biosimilars approved in Europe

Biosimilars/General | Posted 08/07/2011

Last update: 28 January 2022

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally.

Biosimilars applications under review by EMA – January 2022

Biosimilars/General | Posted 21/01/2022

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Biosimilars approved in Brazil

Biosimilars/General | Posted 14/01/2022

In Brazil, the regulatory body for the approval of biologicals is the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA), which is linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory.

British Columbia expands biosimilar switching programme to include insulin

Biosimilars/General | Posted 14/01/2022

The Canadian province of British Columbia has expanded its biosimilar switching programme to include rapid-acting insulin products. Patients taking Humalog (insulin lispro) and NovoRapid (insulin aspart) will have six months to switch to a biosimilar version.

Viatris/Biocon launch two versions of Semglee to accommodate rebates

Biosimilars/General | Posted 17/12/2021

Viatris (formerly Mylan) and Biocon have launched two versions of their interchangeable biosimilar Semglee (insulin glargine) on the US market, at different price points, in order to accommodate rebates and increase market share.

Interchangeable insulin glargine biosimilars available through Prime Therapeutics and Walgreens

Biosimilars/General | Posted 10/12/2021

In November 2021, it was announced that, in the US, insulin glargine biosimilars co-developed by Viatris and Biocon Biologics will be preferentially offered through Prime Therapeutics pharmacy benefit management organization and will be available to members of Walgreens Prescription Savings Club.

Patients from Uruguay request that non-interchangeability of biotherapeutics be regulated

Biosimilars/General | Posted 03/12/2021

Patients demand guarantees that authorities will not make switches of biotherapeutic drugs solely for economic reasons and without considering the medical decision. This was expressed by the Uruguay Patients Alliance at the First National Biotechnology Forum. The main objective of this forum was to create a meeting place for the academic world, patients and health authorities in the field of biotechnology and innovation.

Concerns over Canada’s New Brunswick transition to biosimilars

Biosimilars/General | Posted 26/11/2021

Several biological medications whose patents have expired will no longer be covered under provincial drug plans of New Brunswick, Canada as of 30 November 2021. These are to be replaced by cheaper biosimilar versions; however, inflammatory disease associations have expressed concerns about the rapid transition.

Biosimilars approved in Chile

Biosimilars/General | Posted 19/11/2021

In Chile, the regulatory body responsible for the approval of biological medicines is the National Drug Agency (Agencia Nacional de Medicamentos, ANAMED), which is part of the Institute of Public Health of Chile (ISP), under the Ministry of Health.

AMD position statement on the use of biocomparables for psoriasis

Biosimilars/General | Posted 19/11/2021

The Mexican Academy of Dermatology (AMD) is a non-profit civil association founded in 1952 and formed by a group of relevant dermatologists dedicated to sharing experiences and keeping up to date with the latest advances in research. This group has developed the following position statement on biosimilars for psoriasis.