Biosimilars/Research

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].

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].

European regulatory framework for approval of biosimilars – perspectives and future developments

Biosimilars/Research | Posted 15/02/2019

Regulatory agencies around the world have reviewed and approved marketing authorization applications for biosimilars via specific marketing authorization procedures that vary between jurisdictions. In Europe, the European Medicines Agency (EMA) has already more than 10 years of experience with review of applications and approval of biosimilars for use in the European Union.

Safety surveillance of bevacizumab biosimilar (Bevax) in Argentina

Biosimilars/Research | Posted 15/02/2019

Benefit-risk evaluations are mandatory throughout the life cycle of a therapeutic agent, to guarantee efficacy for the authorized indications without an unacceptable incidence of adverse effects. This monitoring can be carried out using pharmacovigilance (PhV) procedures, which are vital in the identification and prevention of adverse drug reactions (ADRs). Due to the inherent variability of bioproduction, this is of paramount importance for biological products, including biosimilars.

Positive results for adalimumab and etanercept biosimilars from Sandoz

Biosimilars/Research | Posted 14/12/2018

On 23 October 2018, Sandoz, the generics division of Novartis, presented positive phase III data for its adalimumab and etanercept biosimilars [1, 2].

Positive phase I results for Fresenius Kabi’s pegfilgrastim biosimilar

Biosimilars/Research | Posted 07/12/2018

Fresenius Kabi, one of the independently operated business segments of global healthcare group Fresenius, announced on 9 October 2018 that results from two phase I studies of its pegfilgrastim biosimilar (MSB11455) had met their primary endpoints.

Positive results for Chinese rituximab and trastuzumab copy biologicals

Biosimilars/Research | Posted 07/12/2018

Researchers from Shanghai Henlius Biotech have presented positive phase III study results for their rituximab [1] and trastuzumab [2] copy biologicals.

Bioequivalence of bevacizumab biosimilar (BEVZ92) versus Avastin in mCRC patients

Biosimilars/Research | Posted 28/09/2018

Researchers from mAbxience presented data that supports the pharmacokinetic (PK) bioequivalence between bevacizumab biosimilar BEVZ92 and originator bevacizumab (Avastin) as first-line treatment in combination with fluorouracil, leucovorin and oxaliplatin (FOLFOX) or fluorouracil, leucovorin, and irinotecan (FOLFIRI). in patients with metastatic colorectal cancer (mCRC) [1].

Switching from reference products to biosimilars: the European perspective

Biosimilars/Research | Posted 30/11/2018

The number of biosimilars receiving marketing authorization has grown steadily over the past several years [1, 2] and is expected to continue growing in the future. Particularly when biologicals are prescribed for the treatment of chronic diseases, switching patients from the originator biological to the biosimilar is increasingly becoming an option, allowing for a considerable reduction of public health expenditure. This article [3] provides an overview of current approaches in Europe to switching patients to treatment with biosimilars.

Comparative results for CT-P10 in low-tumour burden FL

Biosimilars/Research | Posted 30/11/2018

According to research in patients with low-tumour burden follicular lymphoma (FL), the efficacy and pharmacokinetics of rituximab biosimilar CT‑P10 are equivalent or non-inferior to the originator rituximab, Roche’s MabThera/Rituxan [1].