Biosimilars

Mylan presents comparability data for trastuzumab biosimilar

Biosimilars/Research | Posted 01/07/2016

Generics giant Mylan Pharmaceuticals (Mylan) presented robust data from its biosimilar trastuzumab programme at the American Society of Clinical Oncology (ASCO) Annual Meeting ASCO 2016 held in Chicago, USA on 3–7 June 2016.

Real-world safety data for epoetin alfa biosimilar

Biosimilars/Research | Posted 01/07/2016

A 2-year post-marketing study of the epoetin alfa biosimilar Binocrit has found the biosimilar to be safe in daily clinical practice, according to the authors [1].

Health Canada approves Inflectra biosimilar for extra indications

Biosimilars/News | Posted 24/06/2016

US-based generics maker Hospira, now part of Pfizer, announced on 14 June 2016 that its infliximab biosimilar Inflectra had received approval from Canada’s medicines regulator, Health Canada, in three extra indications.

Biosimilar rituximab in biological naïve rheumatoid arthritis patients

Biosimilars/Research | Posted 24/06/2016

Cost remains a major constraint in the use of originator biologicals in rheumatology in developing countries, paving the way for ever increasing usage of biosimilars. However, apart from the cost, their efficacy and safety are of tremendous interest to clinicians in both developing and developed worlds.

Insulin biosimilar meets primary endpoint in phase III studies

Biosimilars/Research | Posted 24/06/2016

US pharma giant Merck announced on 13 June 2016 positive results from two phase III studies evaluating its insulin glargine biosimilar (MK-1293).

Improvement in uptake of biosimilars in Spain

Biosimilars/Research | Posted 17/06/2016

Author Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain found that there has been an increase in the uptake of biosimilars in Spain since indicators were introduced [1].

Immunogenicity of biologicals: the role of post-translational modifications

Biosimilars/Research | Posted 17/06/2016

Although produced under strict quality control(s) nascent endogenous proteins and glycoproteins (P/GP) are structurally heterogeneous and subject to further structural changes throughout their in vivo life cycle. A nascent polypeptide chain may be subject to co-translational modifications (CTMs) as it is extruded from the ribosome tunnel, e.g. the addition of oligosaccharide; edited for correct folding and initial oligosaccharide processing within the endoplasmic reticulum and subject to post-translational modifications (PTMs) during passage through the Golgi apparatus. The functional activity of a P/GP may be dependent on further chemical modifications (CMs), e.g. deamidation, enzymatic cleavage. These heterogeneities are compounded when determining the structure of a purified P/GP because further CMs may be introduced during its isolation, purification and characterization [1].

Alvogen opening biosimilars plant in Iceland

Biosimilars/News | Posted 17/06/2016

Iceland-based biopharmaceutical company Alvotech, a sister company of US generics company Alvogen, is set to open its state-of-the-art 11,800 square meter development and manufacturing facility for biosimilars in June 2016.

Effectiveness of ESAs in treating anaemia in kidney disease and cancer patients

Biosimilars/Research | Posted 10/06/2016

Erythropoiesis-stimulating agents (ESAs) are biological analogues of human erythropoietin used for the treatment of anaemia associated with chronic kidney disease (CKD) and chemotherapy treatment in cancer patients [1]. ESA biosimilars have been available on the Italian market since 2007. However, only limited post-marketing data exist on the comparative effectiveness of biosimilar and originator ESAs in routine care.

Biosimilars of eculizumab

Biosimilars/General | Posted 10/06/2016

Last update: 20 October 2017

Eculizumab is a humanized monoclonal antibody that is a terminal complement inhibitor. It is used to treat people with paroxysmal nocturnal haemoglobinuria (PNH), for whom it improves quality of life but does not appear to affect the risk of death. It is also indicated for the treatment of patients with atypical haemolytic uremic syndrome (aHUS) – a disease that primarily affects kidney function – to inhibit complement-mediated thrombotic microangiopathy.

Rituximab biosimilar from Sandoz accepted for review by EMA

Biosimilars/News | Posted 10/06/2016

Sandoz, the generics division of Novartis, announced on 24 May 2016 that its regulatory submission for its proposed rituximab biosimilar (GP2013) had been accepted by the European Medicines Agency (EMA).

Samsung Bioepis infliximab biosimilar accepted for review by FDA

Biosimilars/News | Posted 03/06/2016

Samsung Bioepis (a Biogen and Samsung joint venture) and Merck announced on 24 May 2016 that the US Food and Drug Administration (FDA) had accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis for the companies’ infliximab biosimilar candidate, SB2.

Monoclonal antibodies and the challenge of substitution

Biosimilars/Research | Posted 03/06/2016

Healthcare payers are eagerly awaiting the arrival of biosimilar competition in the innovative monoclonal antibody sector in order to drive down drug prices and increase patients’ access to these medicines. As the first to introduce scientific and regulatory requirements for the approval of biosimilars in 2004, the European Union (EU) has emerged as a testing ground for biosimilars. In view of the lack of stance of EU governments and national institutions on substitution for biosimilars, hospitals and healthcare structures logically took up this major issue.

Roche sues India’s drug regulator over Avastin ‘similar biologics’

Biosimilars/General | Posted 03/06/2016

Switzerland-based drug giant Roche has sued the Drug Controller General of India (DCGI) in the Delhi High Court over ‘similar biologic’ versions of its cancer blockbuster Avastin (bevacizumab).

Pharmacokinetic behaviour of a trastuzumab biocomparables

Biosimilars/Research | Posted 03/06/2016

Biosimilars represent a viable alternative for the treatment of chronic and degenerative diseases of many patients worldwide who cannot afford the costs of biotherapies based on originator products. Trastuzumab is a humanized monoclonal antibody, which is used for the treatment of HER2-positive breast cancer. In the review paper of Miranda-Hernández et al. [1], the authors described the development of a trastuzumab biocomparable by Mexico-based Probiomed. This biocomparable, according to the authors, was developed in compliance with international guidelines and the characterization of Critical Quality Attributes (CQAs), as well as the pharmacokinetic parameters evaluated in healthy volunteers, demonstrated comparability with the reference product.

Switching between different ESAs

Biosimilars/Research | Posted 27/05/2016

Switching between reference biologicals and biosimilars can be a contentious issue. A study from Italy, however, has found that this phenomenon is not limited to reference products and their biosimilars, but also often occurs between originator biologicals and other originator biologicals within the same category [1].

Positive phase III results for omalizumab copy biological

Biosimilars/News | Posted 27/05/2016

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 16 May 2016 that its partner, MabTech had successfully completed a combined phase II and III clinical trial in China for STI-004, a copy biological for omalizumab (Xolair). STI 004 met its primary endpoint in a multicentre, randomized, double-blind, placebo-controlled, clinical study.

Uptake of biosimilars increasing in Spain

Biosimilars/Research | Posted 20/05/2016

Use of biosimilars in Madrid, Spain, has increased after approaches were introduced to try and improve uptake of biosimilars in the country, according to Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain [1].

Clinical and regulatory issues for biosimilars

Biosimilars/Research | Posted 20/05/2016

As the first biosimilars are being approved in the US, there are a number of clinical and regulatory issues that must be considered for the safe and appropriate utilization of these products within the health system [1]. Biosimilars provide the opportunity to lower cost and improve access to important biological treatments. However, their success will depend largely on their acceptance by clinicians, payers and patients.

Samsung Bioepis to launch infliximab biosimilar in South Korea

Biosimilars/News | Posted 20/05/2016

Samsung Bioepis has completed the regulatory process to enable the launch of its second biosimilar Renflexis (infliximab) in South Korea.