Biosimilars

Biosimilars in Europe

Biosimilars/Research | Posted 01/06/2018

The European Medicines Agency (EMA) has pioneered the regulatory aspects of biosimilars since the first approval of a biosimilar in 2006. With the last authorization of bevacizumab in January 2018, 44 biosimilar products have been reviewed by the Committee for Medicinal Products for Human Use (CHMP) of EMA, 41 of them having been granted a marketing authorization [1].

EC approval for infliximab biosimilar Zessly

Biosimilars/News | Posted 25/05/2018

Sandoz, the generics division of Novartis, announced on 24 May 2018 that it had received European Commission (EC) approval for its infliximab biosimilar Zessly (PF‑06438179).

Hetero launches adalimumab similar biologic in India

Biosimilars/News | Posted 25/05/2018

India-based generics maker Hetero Group (Hetero) announced in January 2018 the launch of its product Mabura, a ‘similar biologic’ of adalimumab, in India.

Utilization data and cost-effectiveness of infliximab biosimilar

Biosimilars/Research | Posted 25/05/2018

Studies of Celltrion/Hospira’s infliximab biosimilar (CT‑P13, Remsima/Inflectra) carried out in Canada and Germany have shown that, although there are large savings to be made, there are ‘significant differences in real-world utilization patterns’ of patients prescribed originator infliximab compared to those prescribed biosimilar infliximab (CT‑P13) [1, 2].

Pegfilgrastim biosimilar Lapelga approved in Canada

Biosimilars/News | Posted 18/05/2018

Canada-based Apotex received approval for its pegfilgrastim biosimilar, Lapelga, from Health Canada with positive decision made on 5 April 2018. This marks the first pegfilgrastim biosimilar to be approved by the Canadian medicines regulator.

FDA approves epoetin alfa biosimilar Retacrit

Biosimilars/News | Posted 18/05/2018

The US Food and Drug Administration (FDA) approved its first epoetin alfa biosimilar on 15 May 2018.

Brazilian oncologists favour ‘follow-on biological products’

Biosimilars/General | Posted 18/05/2018

The Brazilian Society of Clinical Oncology (SBOC) has issued a position statement on ‘follow-on biological products’ in oncology. The statement reflects the society’s views on issues such as naming, labelling, safety and efficacy, extrapolation of indications, interchangeability, switching and substitution of ‘follow-on biological products’, as well as on the potential impact ‘follow-on biological products’ may have on the financial burden in health care [1].

Secrecy is an obstacle to the use of biosimilars in the US

Biosimilars/Research | Posted 11/05/2018

Factors that Professor Frank believes may be affecting uptake include naming and interchangeability guidance, insurance payment arrangements and secrecy about manufacturing processes [1]. In this article, secrecy about manufacturing processes is discussed.

Biosimilar etanercept Eucept approved in South Korea

Biosimilars/News | Posted 11/05/2018

South Korea-based LG Chem has obtained regulatory approval to begin marketing and selling its etanercept biosimilar in Korea.

Safety of biosimilar infliximab in pregnant women with IBD

Biosimilars/Research | Posted 11/05/2018

Introduction of the first biosimilar infliximab (CT‑P13, Remsima/Inflectra) for the treatment of inflammatory bowel diseases (IBDs) was aimed to reduce the healthcare cost burden and to increase the number of treated individuals with similar treatment results. Shortly after CT‑P13 has been authorized for usage in clinical practice, many concerns arose due to the fact that the principle of extrapolation of limited clinical results had been applied to the biosimilar, which led to approval of the biosimilar in all the indications of the originator biological (Remicade). However, these concerns have proved to be unfounded, as subsequent studies have confirmed the similar efficacy, safety and immunogenicity of CT‑P13 and Remicade in the general IBD population [1].