Biosimilars

Global harmonization of GMP standards for biologicals

Biosimilars/Research | Posted 20/11/2020

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

Biosimilars/Research | Posted 13/11/2020

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

Biosimilars/General | Posted 13/11/2020

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

Biosimilars/Research | Posted 13/11/2020

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].

GBMA publishes information resources on biosimilars for consumers and carers

Biosimilars/General | Posted 13/11/2020

The Generic and Biosimilar Medicines Association (GBMA), the representative body of generic and biosimilar medicine suppliers in Australia, has recently published information resources for consumers and carers on 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.