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Biosimilars/Research

64 MD002129

Safety of SC form of infliximab biosimilar CT-P13

Biosimilars/Research | Posted 23/08/2019

Positive results for Celltrion Healthcare’s (Celltrion) subcutaneous (SC) formulation of its infliximab biosimilar, CT-P13 (Remsima), have been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].

Clinical Trials 2 V13K29

Positive phase III results for bevacizumab copy biological IBI305

Biosimilars/Research | Posted 16/08/2019

Innovent Biologics (Innovent) has presented positive phase III results for its bevacizumab copy biological IBI305 at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO).

Pegfilgrastim V16B19

Extensive characterization of biosimilars: a pegylated filgrastim study

Biosimilars/Research | Posted 16/08/2019

Pegfilgrastim, is a 38 kDa, pegylated form of filgrastim, with a 20 kDa monomethoxypolyethylene glycol (mPEG) molecule covalently bound to the N-terminal methionyl residue of filgrastim developed by Amgen. Attachment of the mPEG-moiety enables a longer half-life, that enables only once-per-cycle administration for the management of chemotherapy-induced neutropenia. This results in a much simpler treatment regime for patients. The biosimilar version of pegfilgrastim developed by Intas Pharmaceuticals, and marketed by Accord Healthcare under the brand name Pelgraz, is one of the first pegfilgrastim biosimilars to be approved for market authorization in the European Union (EU) [1].

Suffix V16F10LB

Distinct suffixes will aid biosimilar competition, says new research

Biosimilars/Research | Posted 09/08/2019

The differential naming of originator and biosimilar products supports accurate pharmacovigilance and promotes biosimilar uptake, finds a literature review recently published in GaBI Journal [1].

Switching mAb Pfizer V18K30

Real-world data on switching of etanercept biosimilars

Biosimilars/Research | Posted 09/08/2019

Real-world and clinical data from different studies involving switching to etanerept biosimilars were presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].

Health and Safety V15C26

Long-term safety results for adalimumab biosimilar

Biosimilars/Research | Posted 02/08/2019

ABP 501 is an adalimumab biosimilar which was compared to reference adalimumab in a 24-week phase lll study demonstrating equivalent efficacy and similar safety and immunogenicity [1]. The results of this clinical trial, along with the totality of evidence from analytical and biofunctional evaluation, lead to the approval of this adalimumab biosimilar for rheumatoid arthritis in the European Union and the US. ABP 501 is marketed as Amgevita in Europe and other markets. However, it will not be available in the US until 2023 due to an agreement between Amgen, the developer of the biosimilar, and AbbVie who manufactures the originator product, Humira (adalimumab) [2].

Clinical Trials 2 V13K29

Positive phase III data for adalimumab copy biologicals

Biosimilars/Research | Posted 02/08/2019

Positive phase III data for adalimumab copy biologicals has been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].

Medical Globe V13K15

Positive results for rituximab non-originator and copy biologicals

Biosimilars/Research | Posted 26/07/2019

Positive results for the rituximab non-originator biological BCD-020 (AcellBia) and for the rituximab copy biological HLX01 (Hanlikon) have been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1, 2].

24-AA011041

Positive phase III results for trastuzumab biosimilar HD201

Biosimilars/Research | Posted 26/07/2019

Singapore-based Prestige BioPharma (Prestige) announced on 24 June 2019 positive phase III data for its trastuzumab biosimilar, HD201. The results, according to Prestige, ‘confirm the similarities between HD201 and trastuzumab’.

Biological large Hanyang Univ V15c13

Positive phase III results for trastuzumab follow-on biological Zedora

Biosimilars/Research | Posted 19/07/2019

Results of a post-marketing study of Biocon and Mylan’s trastuzumab biosimilar Zedora (MYL-1401O) compared to Herceptin (trastuzumab) has shown equivalent safety data to the originator biological in breast and gastric cancer, according to the authors [1].

Immunogenicity Lonza V18D06

Real-world data confirms safety of infliximab biosimilar CT-P13

Biosimilars/Research | Posted 19/07/2019

Positive real-world data has been presented for Celltrion’s infliximab biosimilar CT P13 at the European Congress of Rheumatology 2019 (EULAR 2019).

56 AA011042

How local policy measures and practices influence originator biological and biosimilar market dynamics in Sweden

Biosimilars/Research | Posted 21/06/2019

The licensing of biologicals, including biosimilars, in Europe is centralized via the European Medicines Agency (EMA). Subsequently, individual European Member States are responsible for pricing, reimbursement and policies on market entry and use of medicines. This decentralized responsibility results in diverging approaches towards market entry and uptake of biosimilars and contributes to variation in the use of biosimilars across European countries, and even within countries differences in biosimilar uptake levels exist. The latter is the case for the 21 counties of Sweden, implying that decisions taken by their county councils play a role in market access of biosimilars, alongside policy measures and incentives provided at the national level.

MS Nerve Cells V13C03

Recommendations for similar biotherapeutic products published by Latin American MS experts

Biosimilars/Research | Posted 21/06/2019

Recommendations for the use of similar biotherapeutic products for multiple sclerosis (MS) have been issued by a group of experts from Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Peru, Uruguay and Venezuela.

Clinical Trials 2 V13K29

Positive phase I results for Bio-Thera’s bevacizumab copy biological

Biosimilars/Research | Posted 21/06/2019

China-based Bio‑Thera Solutions (Bio‑Thera) has published phase I results for its candidate bevacizumab copy biological, BAT1706 [1].

IBD 1

Biosimilars to replace older biologicals for IBD

Biosimilars/Research | Posted 07/06/2019

Biosimilars will gradually replace older biological drugs for IBD, however, issues – such as the safety of multiple switches – remain, says a recent assessment published in Digestive Diseases and Sciences [1].

Pharmacokinetics 1 V13K15

Positive results for rituximab copy biological IBI301

Biosimilars/Research | Posted 31/05/2019

US-based pharma giant Eli Lilly, and its partner China-based Innovent Biologics (Innovent), announced on 7 May 2019 positive data from two clinical studies of their rituximab copy biological (IBI301) compared to Rituxan (rituximab).

GaBI J 2012-1 Cover V12b13PA

GaBI Journal is the number one journal publishing on biosimilars

Biosimilars/Research | Posted 24/05/2019

The first ever global bibliometric analysis on biosimilars finds that GaBI Journal is the number one journal publishing on biosimilars. The study also shows that research on biosimilars is increasing, but is currently dominated by countries in the West such as the USA [1].

Anaemia V13D05

BiosanaPharma starts phase I trial for omalizumab biosimilar in Australia

Biosimilars/Research | Posted 24/05/2019

Dutch biosimilars developer BiosanaPharma announced on 21 February 2019 that it had received permission from the Australian Bellberry Human Research Ethics Committee (HREC) to start a phase I clinical trial of their first pipeline product, omalizumab.

Cancer Cell V13I20

ASCO/ASH give recommendations for biosimilar ESAs

Biosimilars/Research | Posted 17/05/2019

Recommendations for biosimilar erythropoiesis-stimulating agents (ESAs) in the management of cancer-associated anaemia have been issued by the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH).

Educate Yourself V13H02

Biosimilars education still needed for US and EU clinicians

Biosimilars/Research | Posted 10/05/2019

A review of the literature has concluded that healthcare providers are still cautious when it comes to biosimilars and that clinician-directed education is still needed to increase biosimilar knowledge, facilitate prescribing changes and increase use of biosimilars [1].