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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].

Is switching to biosimilar infliximab safe?

Building on a number of studies on biosimilar infliximab for inflammatory bowel disease (IBD), a recent review shows switching to CT-P13 is safe, but more evidence is needed on switching back to originator and switching between biosimilars [1].

Biosimilars to replace older biologicals for IBD

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].

Positive results for rituximab copy biological IBI301

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 Journal is the number one journal publishing on biosimilars

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].

BiosanaPharma starts phase I trial for omalizumab biosimilar in Australia

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.

ASCO/ASH give recommendations for biosimilar ESAs

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).