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Research

Long-term safety results for adalimumab biosimilar

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].

Positive phase III data for adalimumab copy biologicals

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

Positive results for rituximab non-originator and copy biologicals

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].

Positive phase III results for trastuzumab biosimilar HD201

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’.

Positive phase III results for trastuzumab follow-on biological Zedora

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].

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

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

Asian specialists recommendations for off-patent biologicals in IBD

Gastroenterologists from across Asia have published a list of recommendations for the use of biologicals and off-patent biologicals in inflammatory bowel disease (IBD) in Asia [1].

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

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.

Recommendations for similar biotherapeutic products published by Latin American MS experts

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.

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

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