Biosimilars

Applications for adalimumab and trastuzumab biosimilars submitted to FDA

Biosimilars/News | Posted 04/02/2022

Korea-based Samsung Bioepis and partner US-based Organon announced on 5 January 2022 that the US Food and Drug Administration (FDA) had accepted the application for their proposed citrate-free, high-concentration (100 mg/mL) adalimumab biosimilar (SB5). A low-concentration formulation of SB5, Hadlima (adalimumab-bwwd), was approved in the US in July 2019 [1].

The impact of insulin biosimilars on the diabetes landscape

Biosimilars/Research | Posted 04/02/2022

The cost of diabetes care in the US continues to rise, with insulin accessibility and affordability a particular concern for providers and patients. Increased competition from increased availability of insulin biosimilars may help address these issues.

Northwest Territories, Canada announces biosimilars switching policy

Biosimilars/General | Posted 04/02/2022

The Northwest Territories (NWT) has become the fifth jurisdiction in Canada to implement a biosimilars switching policy. The policy begins from 21 December 2021 and includes 10 biologicals.

FDA approves adalimumab and insulin glargine biosimilars Yusimry and Rezvoglar

Biosimilars/News | Posted 28/01/2022

The US Food and Drug Administration (FDA) has approved the adalimumab biosimilar Yusimry (adalimumab-aqvh) and the insulin glargine biosimilar Rezvoglar (insulin glargine-aglr) [1].

Differences in immunogenicity, pharmacovigilance and legal documents in biological products in Latin America

Biosimilars/Research | Posted 28/01/2022

A study published in 2021 and carried out by Ramírez-Telles et al. examined the immunogenicity, pharmacovigilance and legal documentation of biological and biotechnological drugs as aspects required in the regulations for the registration of these products. This study was conducted in nine Latin American countries – Brazil, Chile, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras and Panama – that currently have a regulatory framework for their registration [1].

Biosimilars approved in Ecuador

Biosimilars/General | Posted 28/01/2022

In Ecuador, the regulatory body for the approval of biologicals is the National Agency for Regulation, Control and Health Surveillance (ARCSA).

Biological standardization of bevacizumab: impact on global harmonization of potency assessment

Biosimilars/Research | Posted 21/01/2022

Bevacizumab is a humanized monoclonal antibody (mAb) targeting vascular endothelial growth factor (VEGF), which causes excessive growth of new blood vessels from pre-existing ones in the form of angiogenesis, underlying pathology of cancers and intraocular neovascular diseases. Through binding to soluble VEGF, bevacizumab sterically blocks the interaction of VEGF with VEGF receptor 2 on endothelial cells and thereby interrupts the activation of downstream signalling for angiogenesis. Bevacizumab is indicated for the treatment of a range of cancers, including metastatic colorectal cancer, metastatic breast cancer and non-small-cell lung cancer. It is also used for off-label treatment of eye diseases including neovascular age-related macular degeneration and diabetic macular oedema.

Canada approves adalimumab biosimilars Simlandi and Yuflyma

Biosimilars/News | Posted 21/01/2022

Canada’s drug regulator, Health Canada, has approved the adalimumab biosimilars Simlandi (AVT02) and Yuflyma (CT-P17).

Biosimilars applications under review by EMA – January 2022

Biosimilars/General | Posted 21/01/2022

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Real-world data cannot replace post-approval confirmatory trials

Biosimilars/Research | Posted 21/01/2022

A study published in JAMA Network Open [1] finds that real-world data are not sufficient to confirm the benefits of drugs approved by the US Food and Drug Administration’s (FDA) accelerated approval programme, and therefore cannot replace post-approval confirmatory trials.

Etanercept biosimilars delayed until 2029 in US

Biosimilars/News | Posted 14/01/2022

Yet another patent challenge to Amgen’s originator etanercept, Enbrel, has been denied in the US.

Differences in clinical studies and pharmacovigilance of biological drugs in Latin America

Biosimilars/Research | Posted 14/01/2022

Clinical studies are trials conducted in humans to test the efficacy of new drugs, devices, and other forms of treatment, as well as those already approved. On the other hand, preclinical or non-clinical studies are in vitro or in vivo studies, carried out on animals, which are necessary to evaluate the toxicity of the product and prove drug safety.

Biosimilars approved in Brazil

Biosimilars/General | Posted 14/01/2022

In Brazil, the regulatory body for the approval of biologicals is the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA), which is linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory.

British Columbia expands biosimilar switching programme to include insulin

Biosimilars/General | Posted 14/01/2022

The Canadian province of British Columbia has expanded its biosimilar switching programme to include rapid-acting insulin products. Patients taking Humalog (insulin lispro) and NovoRapid (insulin aspart) will have six months to switch to a biosimilar version.

Canada approves filgrastim biosimilar Nypozi

Biosimilars/News | Posted 14/01/2022

Canada’s drug regulator, Health Canada, has approved the filgrastim biosimilar Nypozi (TX01). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

Regulations of the registration of biosimilars in Latin America

Biosimilars/Research | Posted 17/12/2021

In the review and comparison of biosimilar products performed in the nine Latin American countries, particularities were found regarding their definition, as some regulations do not include the term, affecting the biosimilarity exercise and clinical and non-clinical information. In addition, differences were also found in aspects of their use, such as extrapolation of indications and automatic substitution or interchangeability. As for its labelling, further research by health authorities is required [1].

New Zealand announces funding for adalimumab biosimilar

Biosimilars/News | Posted 17/12/2021

New Zealand has announced that, in order to widen access to adalimumab, it will now fund the adalimumab biosimilar Amgevita.

Viatris/Biocon launch two versions of Semglee to accommodate rebates

Biosimilars/General | Posted 17/12/2021

Viatris (formerly Mylan) and Biocon have launched two versions of their interchangeable biosimilar Semglee (insulin glargine) on the US market, at different price points, in order to accommodate rebates and increase market share.

Biosimilar uptake and the education of healthcare provider

Biosimilars/Research | Posted 17/12/2021

Affordability and access. Two simple words that nevertheless convey the complex burdens facing many healthcare systems around the world. And within the healthcare realm, there is likely no aspect that embodies issues related to affordability and access more than prescription medicines.

China approves three bevacizumab copy biologicals

Biosimilars/News | Posted 10/12/2021

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has approved three bevacizumab.

Biosimilar reimbursement rules cost Medicare over US$1.5 billion

Biosimilars/Research | Posted 10/12/2021

Current Medicare Part B biosimilar reimbursement rules prevented healthcare savings of over US$1.5 billion between 2015 and 2019, revealed a study published in JAMA Network Open [1].

Interchangeable insulin glargine biosimilars available through Prime Therapeutics and Walgreens

Biosimilars/General | Posted 10/12/2021

In November 2021, it was announced that, in the US, insulin glargine biosimilars co-developed by Viatris and Biocon Biologics will be preferentially offered through Prime Therapeutics pharmacy benefit management organization and will be available to members of Walgreens Prescription Savings Club.

Adalimumab biosimilar launched in Japan

Biosimilars/News | Posted 03/12/2021

Japan-based Mochida Pharmaceutical (Mochida) announced on 25 November 2021 that its adalimumab biosimilar had been launched in Japan following the listing of the drug on the National Health Insurance (NHI).

Evidence on automatic substitution of biologicals is limited

Biosimilars/Research | Posted 03/12/2021

A systematic review of the evidence on automatic substitution of biological medicines [1] finds that current research evidence is mainly based on opinion polls and surveys of low-to-moderate quality, with results that are not generalizable or suitable for guiding policy.

Patients from Uruguay request that non-interchangeability of biotherapeutics be regulated

Biosimilars/General | Posted 03/12/2021

Patients demand guarantees that authorities will not make switches of biotherapeutic drugs solely for economic reasons and without considering the medical decision. This was expressed by the Uruguay Patients Alliance at the First National Biotechnology Forum. The main objective of this forum was to create a meeting place for the academic world, patients and health authorities in the field of biotechnology and innovation.

Definition of biological terms in Latin America

Biosimilars/Research | Posted 03/12/2021

To conduct a comparative study of the health registration regulations for biological and biotechnological drugs in Latin America, Ramírez-Telles et al. made an approximation, as clear as possible, of biological terms: regulatory authority of reference, biotechnological drug, reference biological drug and innovative product. Its objective was to detect the differences and what these variations entailed when comparing the following Latin American countries: Brazil, Chile, Costa Rica, Cuba, Dominican Republic, El Salvador, Guatemala, Honduras and Panama [1].

Celltrion seeks approval for bevacizumab biosimilar in Europe, US and Korea

Biosimilars/News | Posted 03/12/2021

South Korean biotechnology company Celltrion announced in October 2021 that it had applied for marketing approval for its candidate bevacizumab biosimilar (CT P16) in Europe, Korea and the US.

China accepts Bio-Thera’s application for tocilizumab copy biological BAT1806

Biosimilars/News | Posted 26/11/2021

China’s National Medical Products Administration (NMPA) has accepted a marketing authorization application for Bio-Thera Solutions’ (Bio-Thera) copy biological of tocilizumab, an immunosuppressant used in the treatment of arthritis.

Advances for Samsung Bioepis’ eculizumab and trastuzumab biosimilars

Biosimilars/Research | Posted 26/11/2021

Samsung Bioepis has announced the completion of its global phase III clinical trials of a biosimilar of Soliris (eculizumab), for treating certain rare blood diseases. In addition, it also presented its results from a five-year follow-up study that showed its biosimilar Ontruzant (trastuzumab) has comparable cardiac safety profiles and long-term efficacy as the originator, Herceptin.

Concerns over Canada’s New Brunswick transition to biosimilars

Biosimilars/General | Posted 26/11/2021

Several biological medications whose patents have expired will no longer be covered under provincial drug plans of New Brunswick, Canada as of 30 November 2021. These are to be replaced by cheaper biosimilar versions; however, inflammatory disease associations have expressed concerns about the rapid transition.

Biosimilar mAb development – quality similarity considerations

Biosimilars/Research | Posted 26/11/2021

Since 2013, when the first biosimilar monoclonal antibody (mAb) was approved by the European Medicines Agency (EMA), the number of approved biosimilar mAbs has been increasing dramatically [1]. The large number of approved biosimilar mAbs in both the European Union (EU) and the US makes the evaluation of these applications possible from a product quality perspective.

Regulation of the registration of biological drugs in Latin America

Biosimilars/Research | Posted 19/11/2021

Biological drugs are defined as products with active ingredients produced from a biological source, whereas a biotechnological product is developed from the isolation of a gene of interest and its cloning [1].

Biosimilars approved in Chile

Biosimilars/General | Posted 19/11/2021

In Chile, the regulatory body responsible for the approval of biological medicines is the National Drug Agency (Agencia Nacional de Medicamentos, ANAMED), which is part of the Institute of Public Health of Chile (ISP), under the Ministry of Health.

AMD position statement on the use of biocomparables for psoriasis

Biosimilars/General | Posted 19/11/2021

The Mexican Academy of Dermatology (AMD) is a non-profit civil association founded in 1952 and formed by a group of relevant dermatologists dedicated to sharing experiences and keeping up to date with the latest advances in research. This group has developed the following position statement on biosimilars for psoriasis.

Australia’s PBAC recommends unrestricted benefit listing for rituximab biosimilars

Biosimilars/News | Posted 19/11/2021

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the Pharmaceutical Benefits Scheme (PBS) listing for the rituximab biosimilars Riximyo and Truxima be changed to ‘Unrestricted Benefit listings’.

Biosimilars: Promises made. Promises kept?

Biosimilars/Research | Posted 19/11/2021

Biosimilars are biological products that are highly similar to their reference biologicals. Biosimilars are designed to have comparability with respect to quality, safety and efficacy compared to an already licensed reference biological. Most regulatory agencies, including the European Medicines Agency (EMA), do not require a full clinical dossier for a biosimilar. It is usually possible to carry out one clinical trial in one indication, with the option to extrapolate to other indications of the reference biological [1].

Canada approves filgrastim and insulin aspart biosimilars Nypozi and Kirsty

Biosimilars/News | Posted 12/11/2021

Canada’s drug regulator, Health Canada, has approved the filgrastim and insulin aspart biosimilars Nypozi and Kirsty.

Progress in the regulation of biosimilars in the EU

Biosimilars/Research | Posted 12/11/2021

Analysis of regulation of biosimilars in the EU concludes that regulation is progressing as more knowledge is gained, which is reflected in the changing nature of regulatory guidelines. The authors conclude that the EU framework generates safe and effective biosimilars [1].

Advances for biotech in Korea: Samsung Bioepis, Celltrion and LG Chem

Biosimilars/General | Posted 12/11/2021

Korean companies Samsung Bioepis and Celltrion have accelerated their penetration into the global market, with a total of 11 approvals in Europe and eight in the US. In addition, Korea’s LG Chem has expanded its presence in Japan and China. This growth follows increasing investment in the biotech sector from South Korea’s government and private pharmaceutical companies [1, 2].

Biosimilars, clinical management and incentives

Biosimilars/Research | Posted 12/11/2021

The aim of a study carried out by Spanish researchers was to identify and analyse policies applied in the health services to enhance uptake of biosimilars in the framework of clinical management settings [1]. Incentives, both financial and non-financial, were of particular interest for the authors. They reviewed the relevant experiences developed in different high-income countries with advanced healthcare systems. In addition, they investigated barriers to the implementation of these policies in Spain.