Biosimilars
Asia Pacific countries: future demand for biosimilars
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
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
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
Canada’s drug regulator, Health Canada, has approved the enoxaparin sodium biosimilars Inclunox and Noromby.
Discontinuation following biosimilar switching in IBD patients
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
The Alberta government in Canada has announced updates to the Alberta Biosimilars Initiative.
Global harmonization of GMP standards for biologicals
Biopharmaceuticals are complex as their active pharmaceutical ingredient (API) is manufactured using living systems. In turn, this leads to complex manufacturing processes. A recent GaBI Journal [1] article by Sia et al. has investigated the good manufacturing practice (GMP) standards of various global regulatory authorities (RAs) and international organisations (IOs). It has revealed that we are well on the way to global harmonization of GMP standards that will help bring these products to more people across the globe.
A blueprint for biosimilar assessment without efficacy trials
Comparative efficacy trials have played an important role in biosimilarity assessments. However, with recent technological advances, their role is now being questioned. Research published in Drug Discovery Today [1] outlines the reasons why biosimilar assessments can now be carried out without these trials [2, 3]. It also lays out the requirements for prospective applications without efficacy trials.
Biosimilar advances for Celltrion Healthcare
South Korea-based biotechnology company Celltrion Healthcare announced advances related to their infliximab, omalizumab and adalimumab biosimilars.
Copy biological approvals in China, compared to the US and EU
A review of copy biological approvals in China finds that 75% of approved monoclonal antibodies, fusion proteins and granulocyte colony-stimulating factor (G-CSF) copy biologicals have been successfully commercialized in the country [1].
