Biosimilars

Rituximab biosimilar submitted to EMA and Rituxan gains extra indication

Biosimilars/News | Posted 20/07/2018

Poland-based Mabion announced on 1 June 2018 that its candidate rituximab biosimilar (MabionCD20) had been accepted for regulatory review by the European Medicines Agency (EMA).

Biosimilars: implications for oncologists

Biosimilars/Research | Posted 13/07/2018

In 2015, the US Food and Drug Administration (FDA) approved its first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since then, FDA has approved four additional biosimilar tumour necrosis factor α inhibitors, and in May 2017, the Oncology Drug Advisory Committee voted in favour of approval of an epoetin alfa biosimilar. Three biosimilar monoclonal antibodies (mAbs) have been approved in the US. Although their indications are for chronic inflammatory diseases, according to authors Robert Rifkin and Susan Peck, oncologists should become familiar with these agents, because they may need to administer these drugs for patients who have concurrent chronic inflammatory conditions [1].

Pfizer gains Japanese approval for infliximab biosimilar

Biosimilars/News | Posted 13/07/2018

Pfizer Japan announced on 2 July 2018 that it had gained Japanese approval for its infliximab biosimilar.

Positive results for infliximab and trastuzumab biosimilars

Biosimilars/Research | Posted 13/07/2018

Celltrion Healthcare (Celltrion) and Samsung Bioepis have both announced positive results for their infliximab and trastuzumab biosimilars, respectively.

US pharmacies sue J&J for stifling infliximab biosimilars

Biosimilars/General | Posted 13/07/2018

Two major US pharmacy chains, Walgreen and Kroger, have sued healthcare giant Johnson & Johnson (J&J) in the US District Court Eastern District of Pennsylvania. The pharmacies allege that J&J prevented insurers from covering biosimilars of its blockbuster immunology drug Remicade (infliximab).

Biosimilars applications under review by EMA – June 2018

Biosimilars/General | Posted 06/07/2018

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.

Biosimilarity testing using very low doses of rituximab

Biosimilars/Research | Posted 06/07/2018

Rituximab is a chimeric, monoclonal antibody directed against CD20 expressed on B lymphocytes [1]. Currently approved indications for use are non-Hodgkin lymphomas, chronic lymphatic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic angiitis [2]. However, rituximab is frequently used ‘off label’ for the treatment of numerous antibody-dependent autoimmune diseases [3].

FDA rejects botulinum toxin biosimilar from Evolus

Biosimilars/News | Posted 06/07/2018

US-based Evolus announced on 16 May 2018 that the US Food and Drug Administration (FDA) had rejected its application for approval of DWP‑450 (prabotulinumtoxinA).

FDA rejects Amgen’s trastuzumab biosimilar

Biosimilars/News | Posted 29/06/2018

Biotech giant Amgen announced on 4 June 2018 that the US Food and Drug Administration (FDA) had rejected the application for approval of its trastuzumab biosimilar.

Biosimilar insulins have same efficacy and safety as reference biologicals

Biosimilars/Research | Posted 29/06/2018

Researchers from the US have found that biosimilar insulins have comparable safety and clinical efficacy as their reference biologicals [1].

Biosimilar infliximab blocked in Australia

Biosimilars/General | Posted 29/06/2018

Switzerland-based drug giant F. Hoffmann-La Roche (Roche) has gained a temporary order in an Australian Federal Court blocking Sandoz from launching its rituximab biosimilar.

Savings with use of biosimilar trastuzumab for breast cancer patients in Croatia

Biosimilars/Research | Posted 29/06/2018

Breast cancer is worldwide the most common cancer in women. In 2012 alone, there were approximately 464,000 new cases and 131,000 deaths from breast cancer in Europe. In Croatia, breast cancer was the fourth leading cause of death among women and ninth in both sexes in 2016.

Biosimilars and the role of regulatory authorities

Biosimilars/Research | Posted 22/06/2018

According to authors Hye-Na Kang and Ivana Knezevic, from the World Health Organization (WHO), market access to biosimilars can be restricted by several factors [1]:
(i) manufacturing processes may be expensive and complex
(ii) patents on the manufacturing processes of the original product may not have expired
(iii) biosimilar manufacturers may have limited access to data on the original product
(iv) appropriate regulatory frameworks may not be in place
(v) government policies on switching to biosimilars, pricing and reimbursement may be lacking.

Celltrion resubmits biosimilar trastuzumab to FDA

Biosimilars/News | Posted 22/06/2018

South Korean biotechnology company Celltrion announced on 18 June 2018 that it had resubmitted its application for marketing approval for its candidate trastuzumab biosimilar, CT‑P6, to the US Food and Drug Administration (FDA).

Efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501

Biosimilars/Research | Posted 22/06/2018

Adalimumab is the most commonly prescribed biological and is approved for rheumatoid arthritis as well as psoriasis, psoriatic arthritis, along with Crohn’s and ulcerative colitis. Its patent life terminated in 2016 in the US [1]. However, in the US AbbVie has stated that, although the composition of matter patent covering Humira expired in December 2016, non-composition of matter patents covering Humira expire no earlier than 2022. The company has therefore made settlement agreements with Amgen and Samsung Bioepis, delaying the launch of biosimilars until January 2023 [2, 3].

Spanish associations sign biosimilars collaboration

Biosimilars/General | Posted 22/06/2018

The Spanish Association of Biosimilar Medicines (BioSim) announced on 21 March 2018 that BioSim and the Federation of Spanish Medical Scientific Associations (FACME) have signed a collaboration agreement that includes the creation of a joint working group to share up-to-date information on biosimilars.

Life cycle and regulatory evaluation of biosimilars

Biosimilars/Research | Posted 15/06/2018

The life cycle of a biosimilar, like any biological, starts with research and development, then manufacturing, and is followed by regulatory evaluation of quality, safety and efficacy for both licensing and post-licensing oversight. Once licensed, a biosimilar is an individual product and post-licensing evaluation should be carried out like any other biological. The only difference for a biosimilar is that regulatory approval relies on the safety and efficacy data and knowledge gained during the development and licensing of an originator, or reference product.

Etanercept biosimilars submitted to EMA and launched in Japan

Biosimilars/News | Posted 15/06/2018

An etanercept biosimilar has been submitted to the authorities in Europe and Japan, and another etanercept biosimilar has been launched in Japan.

WuXi Biologics expands its biologicals manufacturing facilities

Biosimilars/General | Posted 15/06/2018

China-based WuXi Biologics, headquartered in Wuxi city of Jiangsu Province, is expanding its biologicals manufacturing capacity with new facilities planned in Ireland, China, Singapore and the US.

Regulating biosimilars throughout their life cycle

Biosimilars/Research | Posted 08/06/2018

A resolution to increase access to life-saving biologicals was passed in May 2014 at the Sixty-seventh World Health Assembly of the World Health Organization (WHO) [1]. However, there still exist barriers to market access for biosimilars. Authors Drs Hye-Na Kang and Ivana Knezevic, from WHO, discuss the factors that give rise to these barriers and explain the importance of regulatory oversight throughout the product life-cycle of biosimilars [2].

EMA approves adalimumab and trastuzumab biosimilars

Biosimilars/News | Posted 08/06/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 1 June 2018 that it had recommended granting marketing authorization for the adalimumab biosimilars Halimatoz, Hefiya and Hyrimoz, and also for the trastuzumab biosimilar Trazimera.

FDA approval for pegfilgrastim biosimilar Fulphila

Biosimilars/News | Posted 08/06/2018

The US Food and Drug Administration (FDA) announced on 4 June 2018 that it had approved its first pegfilgrastim biosimilar.

Celltrion resubmits biosimilar rituximab to FDA

Biosimilars/News | Posted 01/06/2018

South Korean biotechnology company Celltrion announced on 30 May 2018 that it had resubmitted its application for marketing approval for its candidate rituximab biosimilar, CT‑P10, to the US Food and Drug Administration (FDA).

Interchangeability between infliximab biosimilars with respect to immunogenicity

Biosimilars/Research | Posted 01/06/2018

In their editorial, Katsanos and colleagues [1] discuss a study carried out by Italian and Spanish researchers on the immunogenicity of infliximab biosimilars that finds that there is full interchangeability between infliximab biosimilars with respect to immunogenicity [2].

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.