Biosimilars/Research
Relative bioavailability of FKB327 when administered using different methods
FKB327 is a biosimilar of Humira (adalimumab), a recombinant, human immunoglobulin G1 monoclonal antibody specific for human tumour necrosis factor alpha (TNF-α). The European Medicines Agency approved FKB327, as Hulio, in 2018 [1].
Biosimilars in the age of patient-centricity
In 2020, nearly all pharmaceutical companies claim to be ‘patient-centric’. In fact, some companies have even initiated processes of designing new treatments ‘around the patient’ and convened ‘Patient Advisory Boards’ to ensure patients provide their input into clinical trial design. In addition, though to a lesser extent, some have also developed educational programmes to ensure clinicians and patients truly understand the use and function of biosimilars. Regulators have also participated in the effort to ensure that patients consent to be prescribed biosimilar treatments and are well informed of their relative risks and benefits. President of the French Association of Pharmaceutical Medicine, Dr Francois-Xavier Frapaise, discusses how these latest ‘patient-centric’ efforts affect patients [1].
Is switching to biosimilar infliximab safe?
Building on a number of studies on biosimilar infliximab for inflammatory bowel disease (IBD), a recent review shows switching to CT-P13 is safe, but more evidence is needed on switching back to originator and switching between biosimilars [1].
First subjects dosed in Australian phase I study of denosumab biosimilar
Taiwan-based JHL Biotech announced on 18 May 2020 that the first group of subjects has been randomized and dosed in the week of 11 May 2020 in the company’s Australian phase I clinical trial of its candidate denosumab biosimilar (JHL1266) in healthy subjects.
Samsung Bioepis releases data on trastuzumab and ranibizumab biosimilars
Samsung Bioepis has released follow-up data for its approved trastuzumab biosimilar Ontruzant, as well as interim results for its proposed Lucentis (ranibizumab) biosimilar.
Safety of switching between reference products and biosimilars
The safety of switching a patient under chronic treatment with a reference biological to a biosimilar has been a topic of ongoing debate since the first biosimilar approval in Europe in 2006. The topic sparked further discussion with the arrival of the more complex monoclonal antibody biosimilars. Concerns have been raised that switching between highly similar but non-identical versions of a biological medicine might lead to increased immunogenicity and as such, impact treatment outcomes. The existing stakeholder uncertainty regarding the safety of switching may have been curbing the use of biosimilars in clinical practice and guidance to support healthcare professionals with clinical decision-making is needed.
Hepatobiliary events similar for SB4 and Enbrel in IJD
According to a study carried out by researchers from Denmark, hepatobiliary adverse events occur at a similar frequency in patients treated with the etanercept biosimilar Benepali (SB4) compared to the originator product, Enbrel, in inflammatory joint disease (IJD) [1].
Do patent strategies delay market entry of biosimilar monoclonal antibodies in Europe?
Patents have been shown to be the main determinant to guarantee market exclusivity of originator biologicals [1], with patent disputes causing uncertainty on a patent’s validity and subsequently potentially influencing launch dates of competitor products, such as biosimilars [2]. In addition, the launch date of a biosimilar might be affected by strategies for prolongation of exclusivity rights on the originator product, such as filing additional patents for a new formulation, new indication or new dosage regime [3].
Scientific evidence in development of trastuzumab biosimilar ABP 980
ABP 980 (Kanjinti) is a biosimilar to trastuzumab reference product (RP) (Herceptin), a monoclonal antibody directed against human epidermal growth factor receptor 2 (HER2). A biosimilar is highly similar to a licensed biological with no clinically meaningful differences in safety, purity and potency [1, 2]. Kanjinti is approved in the US, European Union, and as trastuzumab BS [trastuzumab biosimilar 2] in Japan for all Herceptin indications, which include treatment of HER2 positive (HER2+) metastatic breast cancer, early breast cancer (EBC), and metastatic gastric cancer [3-5]. Development and approval were based on a totality of evidence (TOE) approach, involving stepwise generation of comparative analytical (structural and functional), preclinical, and clinical (pharmacokinetics [PK], pharmacodynamics [PD], efficacy, safety and immunogenicity) evidence [6].
Biosimilar education gaps in oncology
A survey administered by the International Society of Oncology Pharmacy Practitioners (ISOPP) identifies key educational needs on biosimilars amongst its practitioners, including how to compare a biosimilar to an originator and how to manage switching [1].
