Biosimilars

Biosimilars in Europe

Biosimilars/Research | Posted 01/06/2018

The European Medicines Agency (EMA) has pioneered the regulatory aspects of biosimilars since the first approval of a biosimilar in 2006. With the last authorization of bevacizumab in January 2018, 44 biosimilar products have been reviewed by the Committee for Medicinal Products for Human Use (CHMP) of EMA, 41 of them having been granted a marketing authorization [1].

EC approval for infliximab biosimilar Zessly

Biosimilars/News | Posted 25/05/2018

Sandoz, the generics division of Novartis, announced on 24 May 2018 that it had received European Commission (EC) approval for its infliximab biosimilar Zessly (PF‑06438179).

Hetero launches adalimumab similar biologic in India

Biosimilars/News | Posted 25/05/2018

India-based generics maker Hetero Group (Hetero) announced in January 2018 the launch of its product Mabura, a ‘similar biologic’ of adalimumab, in India.

Utilization data and cost-effectiveness of infliximab biosimilar

Biosimilars/Research | Posted 25/05/2018

Studies of Celltrion/Hospira’s infliximab biosimilar (CT‑P13, Remsima/Inflectra) carried out in Canada and Germany have shown that, although there are large savings to be made, there are ‘significant differences in real-world utilization patterns’ of patients prescribed originator infliximab compared to those prescribed biosimilar infliximab (CT‑P13) [1, 2].

Pegfilgrastim biosimilar Lapelga approved in Canada

Biosimilars/News | Posted 18/05/2018

Canada-based Apotex received approval for its pegfilgrastim biosimilar, Lapelga, from Health Canada with positive decision made on 5 April 2018. This marks the first pegfilgrastim biosimilar to be approved by the Canadian medicines regulator.

FDA approves epoetin alfa biosimilar Retacrit

Biosimilars/News | Posted 18/05/2018

The US Food and Drug Administration (FDA) approved its first epoetin alfa biosimilar on 15 May 2018.

Brazilian oncologists favour ‘follow-on biological products’

Biosimilars/General | Posted 18/05/2018

The Brazilian Society of Clinical Oncology (SBOC) has issued a position statement on ‘follow-on biological products’ in oncology. The statement reflects the society’s views on issues such as naming, labelling, safety and efficacy, extrapolation of indications, interchangeability, switching and substitution of ‘follow-on biological products’, as well as on the potential impact ‘follow-on biological products’ may have on the financial burden in health care [1].

Secrecy is an obstacle to the use of biosimilars in the US

Biosimilars/Research | Posted 11/05/2018

Factors that Professor Frank believes may be affecting uptake include naming and interchangeability guidance, insurance payment arrangements and secrecy about manufacturing processes [1]. In this article, secrecy about manufacturing processes is discussed.

Biosimilar etanercept Eucept approved in South Korea

Biosimilars/News | Posted 11/05/2018

South Korea-based LG Chem has obtained regulatory approval to begin marketing and selling its etanercept biosimilar in Korea.

Safety of biosimilar infliximab in pregnant women with IBD

Biosimilars/Research | Posted 11/05/2018

Introduction of the first biosimilar infliximab (CT‑P13, Remsima/Inflectra) for the treatment of inflammatory bowel diseases (IBDs) was aimed to reduce the healthcare cost burden and to increase the number of treated individuals with similar treatment results. Shortly after CT‑P13 has been authorized for usage in clinical practice, many concerns arose due to the fact that the principle of extrapolation of limited clinical results had been applied to the biosimilar, which led to approval of the biosimilar in all the indications of the originator biological (Remicade). However, these concerns have proved to be unfounded, as subsequent studies have confirmed the similar efficacy, safety and immunogenicity of CT‑P13 and Remicade in the general IBD population [1].

Biosimilars highlights for 2017

Biosimilars/General | Posted 11/05/2018

There are many product launches and various topics such as naming, extrapolation, interchangeability and switching of biosimilars in 2017 [1]. Important milestones achieved during 2017 were the biosimilar approvals of Renflexis (infliximab-abda), Cyltezo (adalimumab-adbm), Mvasi (bevacizumab-awwb), Ixifi (infliximab‑qbtx), and Ogivri (trastuzumab-dkst), along with the approval of follow-on insulin lispro biological Admelog, by the US Food and Drug Administration (FDA).

Insurance payment arrangements are an obstacle to biosimilars use in the US

Biosimilars/Research | Posted 04/05/2018

The slow development of the market competition for biosimilars in the US may be caused by several factors, according to Professor Richard Frank from the Department of Health Care Policy, Harvard Medical School, Boston, USA [1]. In this article, insurance payment arrangements for biologicals and biosimilars are discussed.

FDA rejects trastuzumab and rituximab biosimilars

Biosimilars/News | Posted 04/05/2018

US pharma giant Pfizer announced on 23 April 2018 that the US Food and Drug Administration (FDA) had rejected its application for approval of its trastuzumab biosimilar. Then Sandoz, part of Novartis, announced on 2 May 2018 that its biosimilar rituximab application had also been rejected.

Biosimilars in rheumatology: the current state of play

Biosimilars/Research | Posted 04/05/2018

Biological disease modifying anti-rheumatic drugs (bDMARDs) have revolutionized the management of rheumatoid arthritis (RA) and other inflammatory diseases. Over two decades, their use has risen exponentially but their significant cost has contributed to increasing healthcare expenditure in many countries. Biosimilar development is an opportunity to lower drug expenses and optimize use. This review detailed the current state of biosimilars in rheumatology, including their development, trial data, economic impact and logistical considerations [1].

AbbVie and Samsung Bioepis reach patent deal over Humira biosimilar

Biosimilars/General | Posted 04/05/2018

Biosimilars maker Samsung Bioepis announced on 5 April 2018 that it had reached a ‘global resolution’ with pharma giant AbbVie ending all patent litigation regarding AbbVie’s blockbuster arthritis drug Humira (adalimumab).

Interchangeability is an obstacle to the use of biosimilars in the US

Biosimilars/Research | Posted 27/04/2018

According to Professor Richard Frank from the Department of Health Care Policy, Harvard Medical School, Boston, USA, there are several factors that may account for the slow development of the market for biosimilars in the US [1]. In this article, the issue of interchangeability of biosimilars is discussed.

Australia approves rituximab biosimilar Truxima

Biosimilars/News | Posted 27/04/2018

South Korean biotechnology company Celltrion announced on 23 April 2018 that Australia’s regulatory body, the Therapeutic Goods Administration (TGA), has approved its rituximab biosimilar, Truxima (CT‑P10).

Phase I study of biosimilar trastuzumab demonstrates equivalent pharmacokinetics to reference product

Biosimilars/Research | Posted 27/04/2018

Trastuzumab, a recombinant humanized monoclonal antibody, acts against the tyrosine kinase human epidermal growth factor receptor 2 (HER2), which is overexpressed in up to 30% of breast cancers and gastric cancers and has been linked to poor prognosis. In the age of targeted anticancer therapy, trastuzumab is a key treatment for patients with HER2-positive (HER2+) tumours and is recommended by a number of clinical guidelines. However, the use of ‘originator’ (or reference) biologicals, such as trastuzumab, is associated with high treatment costs; an issue set to be exacerbated by an ageing population. The improved cost-effectiveness potentially provided by a biosimilar may increase patient access to treatment.

FDA rejects Celltrion/Teva’s rituximab and trastuzumab biosimilars

Biosimilars/News | Posted 20/04/2018

South Korean biotechnology company Celltrion announced on 6 April 2018 that it had received complete response letters (CRLs) from the US Food and Drug Administration (FDA) regarding its candidate rituximab (CT‑P10) and trastuzumab (CT‑P6) biosimilars.

Afucosylated biosimilars: the path to matching interrelated critical quality attributes

Biosimilars/Research | Posted 20/04/2018

Advances in analytical characterization and increased understanding of drug mechanisms of action have resulted in the ability to raise the quality and safety of biosimilars by introducing critical quality attributes (CQA), which must be preserved during the manufacturing process. However, to realize these benefits, biosimilars manufacturers must develop the means to ensure these CQAs are met. For afucosylated IgG1s that rely on afucosylation content for efficacy, this has been challenging, since precisely matching both afucosylation content and biological activity has proven to be extremely difficult. In a recent paper, Chung and Zhan [1] elaborate on the underlying basis of these difficulties and highlight the work of several groups that has opened a path to directly addressing this problem.

Naming is an obstacle to the use of biosimilars in the US

Biosimilars/Research | Posted 20/04/2018

Factors that may account for the slow development of the market for biosimilars in the US are discussed by Professor Richard Frank from the Department of Health Care Policy, Harvard Medical School, Boston, USA [1]. In this article, the factor of biosimilars naming is discussed.

Obstacles to the use of biosimilars in the US

Biosimilars/Research | Posted 13/04/2018

Professor Richard G Frank from the Department of Health Care Policy, Harvard Medical School, Boston, USA, discusses factors that may account for the slow development of competition in the market for biosimilars in the US [1].

EMA approval for infliximab biosimilar Zessly

Biosimilars/News | Posted 13/04/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 March 2018 that it had recommended granting marketing authorization for the infliximab biosimilar Zessly.

Strategies for development and validation of neutralizing antibody assays supporting biosimilars

Biosimilars/Research | Posted 13/04/2018

A biosimilar is a biological product with equivalent safety, purity and potency as an originator reference therapeutic. As such, US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines have stepwise recommendations to demonstrate biosimilarity, which include immunogenicity assessment.

Biosimilar policies in Europe

Biosimilars/Research | Posted 06/04/2018

Across European countries, differences exist in biosimilar policies, e.g. pricing and reimbursement procedures, levels of education, characteristics of covered population and incentivization of stakeholders, leading to variations in uptake of biosimilars and divergences in savings from biosimilars use. Experiences from different European countries with biosimilar policies may offer useful insights into current and future uptake of biosimilars.

EMA approval for trastuzumab biosimilar Kanjinti

Biosimilars/News | Posted 06/04/2018

Etanercept biosimilar SB4 less immunogenic than Enbrel

Biosimilars/Research | Posted 06/04/2018

A research letter published in the British Journal of Dermatology suggests that the biosimilar etanercept SB4 is less immunogenic than the originator product, Amgen/Pfizer’s Enbrel (etanercept) [1].

Spanish gastroenterologists update biosimilar position statement

Biosimilars/General | Posted 30/03/2018

The Spanish Society of Gastroenterology (Sociedad Española de Patología Digestiva,SEPD) has updated its position statement on the use of biosimilars for inflammatory bowel disease (IBD) [1]. The changes in the society’s position reflect the increasing body of evidence supporting the safety and efficacy of biosimilars.

Insulin biosimilar Semglee gains EC and Australian approval

Biosimilars/News | Posted 30/03/2018

India-based Biocon and US-based partner Mylan announced on 28 March 2018 that they had received European Commission (EC) and Australian approval for their co-developed insulin glargine biosimilar, Semglee.

Government policies to maximize social benefit of biosimilars in countries with restricted access to biologicals

Biosimilars/Research | Posted 30/03/2018

The potential value of biosimilars is dependent on patient access to originator biologicals in a given country. If the originator biological is reimbursed without any volume and access restrictions, the main objective of using biosimilars is to generate savings in health expenditures without compromising health outcomes. This disinvestment scenario is mainly applicable for higher income countries. If the original biological product is reimbursed with volume and access restrictions, the main objective of biosimilars is to treat more patients from the same healthcare budget, and hence generate more health gain. This special investment scenario is applicable for lower income European Union (EU) Member States and other middle-income countries. If the originator biological is not reimbursed at all, more affordable biosimilars may create an opportunity for public reimbursement, however, incremental budget is needed to generate more health gain. This investment scenario is applicable for low-income countries [1].

Trastuzumab biosimilar Ontruzant launched in the UK

Biosimilars/News | Posted 23/03/2018

Merck Sharp and Dohme (MSD), which is known as Merck in the US and Canada, announced on 8 March 2018 that it had launched the trastuzumab biosimilar, Ontruzant, in the UK.

Yoshindo and Lupin’s etanercept biosimilar completes trials

Biosimilars/Research | Posted 23/03/2018

YL Biologics announced on 7 February 2018 that the global phase III trials of its etanercept biosimilar have been a success. YL Biologics is a joint venture of India’s Lupin Ltd and Japanese firm Yoshindo that was first announced in 2014 [1]. The etanercept biosimilar has met a successful outcome for rheumatoid arthritis treatment and hopes to compete for a share of the originator Enbrel’s global market of US$11 billion.

PK and PD comparison between rituximab biosimilar RTXM83 and rituximab in diffuse large B-cell lymphoma patients

Biosimilars/Research | Posted 23/03/2018

A requirement for registration of a biosimilar is to demonstrate pharmacokinetic (PK) similarity with the reference product. A population PK model approach is an excellent method for assessing PK similarity, in contrast to the classical one, because it allows comparison of PK properties through the inclusion of sparse data that improves the power to detect any potential differences between the biosimilar and the reference product. Furthermore, the population approach allows quantification of the inter-product and inter-subject variability of PK parameters and identification of covariate factors (demographic, pathophysiological, environmental or concomitant drugs) that influence drug availability [1].

Follow-on biologicals and extrapolation in Brazil

Biosimilars/Research | Posted 16/03/2018

Researchers from Brazil discuss the country’s approach to follow-on biologicals and extrapolation of indications in the country [1].

Insulin glargine biosimilar gains South Korean approval

Biosimilars/News | Posted 16/03/2018

South Korea-based GC Pharma (formerly Green Cross Corporation) announced on 8 March 2018 that it had received approval for its insulin glargine biosimilar Glarzia from the Korean Ministry of Food and Drug Safety (MFDS).

Biosimilar policies around the globe

Biosimilars/Research | Posted 16/03/2018

With the authorization of an increasing number of biosimilars, and the prospect of multiple biosimilar switching, biosimilar naming and the importance of this for pharmacovigilance are coming into sharper focus. Authors from around the world considered various biosimilar issues/policies in different countries and regions [1].

US drug contracting system is ‘rigged’ against biosimilars

Biosimilars/General | Posted 16/03/2018

US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb has said that the drug contracting system in the US is ‘rigged’ against biosimilars. His remarks came during a speech he made on 7 March 2018 at the America’s Health Insurance Plans National Health Policy Conference in Washington DC.

ASCO issues position statement on biosimilars in oncology

Biosimilars/General | Posted 09/03/2018

The American Society of Clinical Oncology (ASCO) has issued a position statement on biosimilars in oncology. The statement reflects the society’s views on issues such as naming, labelling, safety and efficacy, interchangeability, switching and substitution of biosimilars, as well as on the value of biosimilars and prescriber and patient education [1].

Trastuzumab biosimilar launched in South Korea

Biosimilars/News | Posted 09/03/2018

South Korean pharmaceutical company Daewoong Pharmaceutical announced on 5 March 2018 that it had launched trastuzumab biosimilar Samfenet, developed by Samsung Bioepis, in South Korea.

Use and cost of biologicals for cancer treatment in Southern Italy

Biosimilars/Research | Posted 09/03/2018

Oncological-targeted therapies, both biological and non-biological, represent a significant clinical and economic burden in routine care and have a major impact on the sustainability of National Health Services. With this in mind, a study by Lucchesi et al. investigated the use and costs of these targeted therapies for cancer treatment in the general population of Southern Italy during the period 2010−2014 [1].