Biosimilars

Rationale for biosimilar assessment without efficacy trials

Biosimilars/Research | Posted 06/11/2020

An article published in Drug Discovery Today explores the necessity of the clinical efficacy trial in biosimilarity assessments [1].

Innovent and Eli Lilly receive approval for rituximab copy biological in China

Biosimilars/News | Posted 06/11/2020

Innovent Biologics and Eli Lilly have received joint marketing approval from the National Medical Products Administration (NMPA) in China for their rituximab copy biological, Halpryza.

Shared decision-making and the transition to biosimilars

Biosimilars/Research | Posted 06/11/2020

Increasing healthcare cost are forcing health authorities to look for low-cost innovations to help bend the cost curve. Biosimilars, a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biological, are such an innovation [1]. Because biosimilars are often offered at lower prices, their use has been promoted all across the world. The initiating of biosimilars in bio-naïve patients is already commonplace in many countries. However, the transitioning from originator biological to its biosimilar for non-medical reasons is still debated. Different strategies about how and when to transition are formulated and applied.

International Psoriasis Council releases consensus statement on biosimilars

Biosimilars/General | Posted 30/10/2020

The International Psoriasis Council (IPC) Biosimilar Working Group (BSWG) published their consensus statements for the use of biosimilars in the treatment of patients with psoriasis [1].

Canada approves trastuzumab biosimilar Kanjinti

Biosimilars/News | Posted 30/10/2020

Canada’s medicines regulator, Health Canada, has approved the trastuzumab biosimilar Kanjinti by Amgen. This marks the second trastuzumab biosimilar to be approved by Health Canada.

Role of efficacy trials in biosimilar assessments questioned

Biosimilars/Research | Posted 30/10/2020

In recent years, the role of the comparative efficacy trial in biosimilar assessments has been brought into question. This is explored in a recent article published by Bielsky and colleagues [1].

Perceptions of biosimilars and switching in Arab rheumatologists

Biosimilars/Research | Posted 30/10/2020

The introduction of biosimilars into the rheumatology field could lead to dramatic cost savings as has been observed in certain European countries. Their implementation and acquisition, however, is not the same across the world. Many rheumatologists have developed a negative perception toward biosimilars and the process of non-medical switching. As important stakeholders, their views and concerns need to be addressed to ensure an effective introduction of these therapeutic agents. Mohammed Omair and colleagues evaluated how Arab rheumatologists perceive biosimilars in view of understanding the manufacturing and approval process during the Arab League Against Rheumatism Conference (ArLAR) [1].

EMA accepts application for ranibizumab biosimilar from Samsung Bioepis

Biosimilars/News | Posted 23/10/2020

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 6 October 2020 that the European Medicines Agency (EMA) has accepted to review its marketing authorization application for SB11, a biosimilar of Lucentis® (ranibizumab). If successful, this will be the first Lucentis® biosimilar available in Europe.

Biosimilar assessments: do we need efficacy trials?

Biosimilars/Research | Posted 23/10/2020

Regulatory guidelines for biosimilar approval have existed in Europe since 2004. These are based on the totality of evidence from comparative studies with reference products and have always required comparative efficacy studies. However, a recent article by Bielsky et al., published in Drug Discovery Today [1], explores the increasingly questioned role of the clinical efficacy trial in biosimilar approval.

Biopharmaceuticals and biosimilars: manufacturing challenges

Biosimilars/Research | Posted 23/10/2020

Biopharmaceuticals include a complex active pharmaceutical ingredient (API). This is manufactured using living systems such as microbial and mammalian cells which makes manufacture a complicated process. A recent paper by Sia et al. published in GaBI Journal [1] has explored current biopharmaceutical processes and the challenges posed by manufacturer.

Biopharmaceuticals and biosimilars: manufacturing processes

Biosimilars/Research | Posted 16/10/2020

The active pharmaceutical ingredient (API) in biopharmaceuticals is manufactured using living systems such as microbial and mammalian cells. Due to this, their manufacture is complex. A recent review by Sia et al. published in GaBI Journal [1] has carried out an in-depth exploration of current biopharmaceutical manufacturing processes.

EC approval for bevacizumab biosimilar Equidacent

Biosimilars/News | Posted 16/10/2020

Centus Biotherapeutics Ltd announced on 29 September 2020 that the European Commission (EC) granted marketing authorization for Equidacent, its Avastin (bevacizumab) biosimilar.

China accepts application for bevacizumab copy biological

Biosimilars/News | Posted 16/10/2020

The National Medical Products Administration (NMPA) in China has accepted an investigational new drug (IND) application for a bevacizumab copy biological developed by 3SBio and Samsung Bioepis.

Pharmacists are key to quality use of medicines for biosimilars

Biosimilars/Research | Posted 16/10/2020

A commissioned review in The Pharmaceutical Journal [1] on interchangeability of biosimilars highlights the pivotal role pharmacists play in the adoption and appropriate use of biosimilars.

Australian diabetes organizations issue biosimilars position statement

Biosimilars/General | Posted 16/10/2020

In June 2020, the Australian Diabetes Society, Australian Diabetes Educators Association and Diabetes Australia, published a position statement on the use of biosimilar ‘insulins’ for diabetes.

Clinical review of biosimilars approved in oncology

Biosimilars/Research | Posted 09/10/2020

As cancer therapeutics constitutes a large proportion of the biologicals market, and patents have begun to expire, biosimilars have an important role in optimizing patient access and reducing costs in the oncology therapeutic area. Authors Ngo and Chen from the City of Hope National Medical Center, Los Angeles, USA, give an overview of the US Food and Drug Administration (FDA)-approved biosimilars in oncology and their impact on the healthcare system in the Annals of Pharmacotherapy [1]. A summary of the main findings from that article follows.

Biopharmaceuticals and biosimilars: challenges in manufacture, regulation and international harmonization of GMP

Biosimilars/Research | Posted 09/10/2020

Biopharmaceuticals are large molecules that are far more complex than traditional, chemical pharmaceuticals. With patent expiry for many originators, biosimilar versions are expected to flood the market in the years to come. However, the active pharmaceutical ingredients (APIs) of all such products are manufactured using living systems which means that their manufacture and characterization is also complex.

China approves adalimumab copy biological Sulinno

Biosimilars/News | Posted 09/10/2020

China-based Innovent Biologics (Innovent) has received marketing authorization from the National Medical Products Administration (NMPA) for their adalimumab copy biological Sulinno.

Why biosimilar applications fail during regulatory evaluation?

Biosimilars/Research | Posted 02/10/2020

The patent expirations of many blockbuster biologicals have paved the way for development of biosimilars and this has the potential to enhance access to otherwise high-cost biological therapies. Given the complexity of biologicals, the regulatory guidelines for biosimilar approval are meticulous and different from generics. Hence biosimilar developers often face issues during the application evaluation by regulatory authorities. With large number of biosimilars in development stage, it is pertinent for a manufacturer to have a deep understanding of the regulatory approval process. Rathore and colleagues from the Indian Institute of Technology offer insights into the objections raised by the regulatory authorities during evaluation of biosimilar applications for marketing authorization with special emphasis on applications reviewed by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Spectroscopy remains dominant when investigating biosimilar structures

Biosimilars/Research | Posted 02/10/2020

Biopharmacological studies, including biosimilar studies, require investigation of the higher order structure of proteins. A recent review published in GaBI Journal (GABIJ) [1] has found that, although many analytical methods to determine the higher order structures exist, spectroscopic methods remain the most used.