Biosimilars
Biopharmaceuticals and biosimilars: manufacturing challenges
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
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
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
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
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
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
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
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
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?
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).
