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Challenges for European pharmacovigilance Reports | Posted 06/09/2019

The European Union (EU) pharmacovigilance system is one of the most advanced worldwide, but challenges remain for the system. Dr Sabine Straus, Chair of the Pharmacovigilance Risk Assessment Commit...

Teriparatide biosimilar Terrosa launched in Europe Biosimilars/News | Posted 06/09/2019

Hungary-based Gedeon Richter (Richter) announced on 20 August 2019 that it had launched its teriparatide biosimilar Terrosa in Europe immediately following the patent expiry of the reference produc...

Improving access to medicines: the Doha Declaration on the TRIPS Agreement Generics/Research | Posted 06/09/2019

In a recent review, authors ‘t Hoen, Kujinga and Boulet describe the role of the Doha Declaration on the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS)...

Praise for Canada’s BC after it adopts biosimilar transitioning policy Policies & Legislation | Posted 06/09/2019

The Canadian Biosimilars Forum and Green Shield Canada have publicly commended the government of the province of British Columbia (BC) for announcing that it will implement biosimilar transitioning...

Switching from reference to biosimilar infliximab in ankylosing spondylitis patients Biosimilars/Research | Posted 06/09/2019

Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease that affects the spine and the sacroiliac (SI) joints. AS is a type of seronegative spondyloarthropathy [meaning that tests s...

Court rules Amgen’s patents on Enbrel are valid, Sandoz to appeal Biosimilars/General | Posted 06/09/2019

After the US District Court of New Jersey ruled in Amgen’s favour on the validity of its patents for arthritis treatment Enbrel, Sandoz says it will appeal the ruling, which prevents the launch of...

Positive results for Bio-Thera’s arthritis copy biologicals Biosimilars/Research | Posted 06/09/2019

Immune specialists Bio-Thera Pharmaceuticals have begun a phase I trial for its Simponi copy biological and obtained positive results from a phase III trial of its Humira copy biological.

Mylan launches adalimumab biosimilar Hulio in Spain Biosimilars/News | Posted 06/09/2019

US-based drugmaker Mylan announced on 9 July 2019 the launch of its adalimumab biosimilar, Hulio, in Spain; the company’s first biosimilar in the country.