Biosimilars

Real-world data on biosimilars in inflammatory arthritis treatment

Biosimilars/Research | Posted 04/12/2020

The use of biologicals in patients with rheumatic diseases has achieved the therapeutic target, i.e. remission or low disease activity. The share of biologicals has been growing with the approval of biosimilars, which have been recognized for their equivalent efficacy, safety, pharmacokinetics and immunogenicity to the originator, as well as their reduced economic burden.

Genentech sues Centus over Avastin biosimilar

Biosimilars/General | Posted 04/12/2020

Genentech Inc. filed a complaint against Centus in the United States (US) state of Texas on 15 November 2020. It is alleged that Centus’s Equidacent, a biosimilar to Genentech’s Avastin (bevacizumab), infringes 10 US patents.

Study reveals wide variation in US state drug product substitution laws

Biosimilars/Research | Posted 04/12/2020

A new study, published in JAMA Internal Medicine [1], has revealed substantial variation in the drug product substitution rules for pharmacists across states in the US.

FDA accepts application for ranibizumab biosimilar

Biosimilars/News | Posted 27/11/2020

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) and partner US biotechnology company Biogen announced on 18 November 2020 that the US Food and Drug Administration (FDA) had accepted the application for their proposed ranibizumab biosimilar (SB11).

Asia Pacific countries: future demand for biosimilars

Biosimilars/Research | Posted 27/11/2020

The prevalence of chronic diseases like diabetes, cancer and rheumatoid arthritis have been increasing globally, resulting in an ever-growing need for biologicals that are affordable and accessible in the Asia Pacific countries (APAC). Biosimilars are ‘similar’ versions of approved and authorized biological medicines that are already on the market. They typically sell at discounts ranging from 20% to 35% when compared to the reference product [1]. It is expected that introduction of biosimilars into the global markets will erode the total sales of biologicals by as much as 54% through 2022 [2]. Various regulatory bodies such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the World Health Organization (WHO) actively regulate development and commercialization of biosimilars.

Biosimilar toolkit for cancer patients

Biosimilars/General | Posted 27/11/2020

The European Cancer Patient Coalition (ECPC) has launched a biosimilars e-module, or toolkit [1]. This aims to teach patients about the value of biosimilars.

Biopharmaceuticals and biosimilars: regulatory challenges for global harmonization of GMP standards

Biosimilars/Research | Posted 27/11/2020

A recent GaBI Journal [1] article by Sia et al. has explored biopharmaceutical good manufacturing practice (GMP) standards around the globe. The authors uncovered the challenges faced in attempting to achieve global harmonization of biopharmaceutical GMP standards.

Canada approves enoxaparin biosimilars Inclunox and Noromby

Biosimilars/News | Posted 20/11/2020

Canada’s drug regulator, Health Canada, has approved the enoxaparin sodium biosimilars Inclunox and Noromby.

Discontinuation following biosimilar switching in IBD patients

Biosimilars/Research | Posted 20/11/2020

Medical management of inflammatory bowel diseases (IBD) has significantly improved since the introduction of biological therapies over the past 20 years. The adoption of biologicals in IBD care has led to an exponential increase in treatment-related costs, resulting in a huge economic impact. As the patents of older biologicals expire, the interest in marketing comparable versions of the reference products increases, enabling opportunities for the development of similar biological products. Biosimilars have the potential to expand access to biological therapies due to price competition and cost savings [1].

Alberta Biosimilars Initiative: switching policy updates in Canada

Biosimilars/General | Posted 20/11/2020

The Alberta government in Canada has announced updates to the Alberta Biosimilars Initiative.