Biosimilars

Biosimilar pipelines for South Korean firms: LG Chem and GC Pharma

Biosimilars/General | Posted 09/07/2021

Biosimilar makers from South Korea are making their mark, not only in South Korea, but around the world when it comes to biosimilars. Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture) are already becoming major players in the world of biosimilars. While, other Korean companies, such as LG Chem Life Sciences (LG Chem) and GC Pharma (formerly Green Cross) are also expanding their biosimilar pipelines.

Biosimilar epoetin in the US – barriers and recommendations

Biosimilars/Research | Posted 02/07/2021

A review of biosimilar epoetin, which is used to treat cancer and chemotherapy-induced anaemia, shows variable uptake in the US. The authors conclude that safety and pricing considerations are the primary determinants of uptake and make recommendations to increase usage [1].

Canada approves pegfilgrastim biosimilar Nyvepria

Biosimilars/News | Posted 02/07/2021

Canada’s drug regulator, Health Canada, has approved the filgrastim biosimilar Nyvepria (PF-06881894). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

Demand for similar biotherapeutic products in Latin America

Biosimilars/Research | Posted 02/07/2021

Development of biologicals has experienced steady growth over the past three decades. Expiration of patents on many originator biologicals, such as insulin, human growth hormone and erythropoietin, has opened the door for the development of biosimilars. The high cost of biologicals, however, has limited their accessibility, particularly in developing countries. Biosimilars offer much-needed affordability and hence improved accessibility. Global health agencies, such as the World Health Organization, are engaged in developing a prequalification program in order to help countries that do not have strong regulatory systems [1].

US biosimilars information guides and support for cancer biosimilars

Biosimilars/General | Posted 02/07/2021

Pharmaceutical giant, Pfizer, and the Cancer Support Community, in the US, have published guides to biosimilars. In addition, Pfizer is collaborating with The National Comprehensive Cancer Network® (NCCN®) to fund projects to support innovation related to appropriate biosimilar adoption in oncology.

Local level biosimilar prescribing proactivity revealed in Italy

Biosimilars/Research | Posted 25/06/2021

Italian local healthcare authorities are highly proactive regarding actions on prescribing behaviour for off-patent biologicals, reveals a study published in GaBI Journal [1]. However, work needs to be done to appropriately reallocate resources gained through patent expiration.

Biobadamérica promotes the use of biological and biosimilar drugs in Latin America

Biosimilars/General | Posted 25/06/2021

In 2007, the Spanish Society of Rheumatology (Sociedad Española de Reumatología, SER) created the Biobadamérica, an international collaborative project to promote the implementation of national safety registries for the use of biological and biosimilar drugs in Latin American countries [1].

Measures to promote the use of biosimilars

Biosimilars/Research | Posted 25/06/2021

How to increase the uptake of biosimilars is an important issue both in Europe and across the world. Europe, via its centralized European Medicines Agency (EMA), has been very successful in approving biosimilars. There are currently 73 biosimilars approved in Europe, almost all of which were marketed immediately after approval [1]. Despite the success in approving and marketing biosimilars, the uptake of biosimilars does vary between different countries in Europe. To encourage the use of biosimilars, targets and incentives have been used across Europe [2]. However, pricing can also play an important role and was investigated by Josep Maria Guiu Segura and Antoni Gilabert Perramon [3].

Prices for arthritis biologicals in Latin America

Biosimilars/Research | Posted 21/06/2021

Analysis of the prices of biological and biosimilar drugs used to treat rheumatoid arthritis suggests these drugs are more accessible in Spain than in Latin America, but least affordable in the US [1].

FDA accepts application for Lupin’s pegfilgrastim biosimilar

Biosimilars/News | Posted 21/06/2021

India-based generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 2 June 2021 that the US Food and Drug Administration (FDA) had accepted the application for approval for its proposed pegfilgrastim biosimilar.

New data on adalimumab biosimilars from Samsung Bioepis and Boehringer Ingelheim

Biosimilars/Research | Posted 21/06/2021

Recently published data show that switching to Samsung Bioepis adalimumab
biosimilar Imraldi is safe and effective, while data from Boehringer Ingelheim suggest their adalimumab biosimilar, Cyltezo, could be classed as interchangeable.

The role of the patient in treatments with biosimilars in Argentina

Biosimilars/General | Posted 21/06/2021

This is how Dr Eduardo Mysler, Medical Director for the Research Medical Organization (OMI) and rheumatology specialist with a long research career reflects that ‘patients have to understand all the details of their disease’.

Trastuzumab emtansine ‘similar biologic’ Ujvira launched in India

Biosimilars/News | Posted 11/06/2021

India-based generics manufacturer Zydus Cadila (Zydus) announced on 24 May 2021 the launch of its trastuzumab emtansine ‘similar biologic’ Ujvira in India. The launch, according to Zydus ‘marks the world’s first biosimilar antibody drug conjugate (ADC) of trastuzumab emtansine’.

Positive phase III results for tocilizumab biosimilar BAT1806

Biosimilars/Research | Posted 11/06/2021

US biotechnology company Biogen Idec (Biogen) and China-based Bio-Thera announced on 1 June 2021 positive phase III data for their tocilizumab biosimilar, BAT1806. According to the two companies, ‘the comparative study met its primary endpoints and showed equivalent efficacy and comparable safety profile in patients with moderate-to-severe rheumatoid arthritis’.

US Supreme Court rejects Enbrel patent challenge from Sandoz

Biosimilars/General | Posted 11/06/2021

The US Supreme Court has declined to review a patent challenge from Sandoz on Amgen’s blockbuster anti-inflammatory, Enbrel (etanercept). This means Sandoz will not be able to launch its etanercept biosimilar, Erelzi (etanercept-szzs), on the US market until 2029.

Efficacy and safety of Yuflyma vs reference adalimumab in rheumatoid arthritis

Biosimilars/Research | Posted 11/06/2021

Yuflyma (CT-P17) is an adalimumab biosimilar, administered at 100 mg/mL that also has the same citrate-free and high concentration formulation of reference adalimumab. To demonstrate the bioequivalence of CT P17 to reference adalimumab, a randomized, double-blind, active-controlled study in subjects with moderate to severe rheumatoid arthritis (RA) was conducted [1]. The study was designed to demonstrate equivalence of efficacy (ACR20* response rate at Week 24) for CT P17 versus reference adalimumab and to evaluate additional efficacy, pharmacokinetics (PK), usability and safety over one year.

Positive phase I results for Meiji’s ustekinumab biosimilar

Biosimilars/Research | Posted 04/06/2021

Japan-based Meiji Seika Pharma (Meiji) announced on 21 May 2021 positive phase I results for its candidate ustekinumab biosimilar, DMB-3115.

Clinical trials for aflibercept biosimilars

Biosimilars/News | Posted 04/06/2021

Sandoz, the generics division of Novartis, has announced the start of a phase III clinical trial of its aflibercept (Eylea) biosimilar, a treatment for age-related macular degeneration. Clinical trials for a number of competitive biosimilars are also underway.

Biosimilar pipelines for South Korean firms: Celltrion and Samsung Bioepis

Biosimilars/General | Posted 04/06/2021

Biosimilars are becoming more important around the world and Korean companies, such as Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture), are fast becoming major players both in Korea but also worldwide.

Review and meta-analysis of biosimilars for the treatment of rheumatoid arthritis

Biosimilars/Research | Posted 04/06/2021

Authors from Japan provide a new perspective on biosimilars for management of rheumatoid arthritis (RA) to provide evidence of efficacy and safety of biosimilars compared with reference biological disease-modifying anti-rheumatic drugs (bDMARDs) (reference bDMARDs) in patients with RA as a part of the process of developing the 2020 update of the Japan College of Rheumatology (JCR) guidelines for the management of RA [1].

On the edge of transition: European biosimilar clinical trial requirements

Biosimilars/Research | Posted 31/05/2021

Recent debates have focused on the clinical trial requirements for biosimilar approval [1-4]. Further, the regulatory approval of biosimilars in the European Union (EU) has been changed, where in some instances and under certain conditions clinical trials to establish comparable efficacy have been excluded [4]. Still, the regulatory recommendation for more complex molecules such as monoclonal antibodies is without exception to conduct clinical comparability trials [4].

Canada approves five adalimumab biosimilars in last six months

Biosimilars/News | Posted 31/05/2021

Since October 2020, Canada’s drug regulator, Health Canada, has approved no less than five adalimumab biosimilars for the treatment of multiple chronic inflammatory diseases.