Biosimilars
GBMA publishes information resources on biosimilars for consumers and carers
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
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
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
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
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
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
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
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
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?
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.
