Biosimilars

Evidence on biosimilar efficacy and safety leads to ASAS/EULAR recommendation

Biosimilars/Research | Posted 24/03/2017

A study of biological disease-modifying anti-rheumatic drugs (DMARDs) in patients with axial spondyloarthritis (axSpA) found no reason for physicians not to prescribe infliximab biosimilars [1].

Pharma associations issue position paper on biosimilar switching

Biosimilars/General | Posted 17/03/2017

The European Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) have issued joint guidance for prescribers on switching between originator biologicals and biosimilars.

Improving efficacy of biologicals without increasing cost

Biosimilars/Research | Posted 17/03/2017

Biologicals targeting antitumour necrosis factor-α, such as Remicade (infliximab) and Humira (adalimumab), have been used for the treatment of chronic inflammatory diseases for many years. The advent of biological therapies raised significant pharmacoeconomic concerns, because the cost of biological treatment is much higher than the cost for conventional treatments, typically Euros 10.000‒20.000 per patient per year. This is an issue discussed by Professor Ann Gils from the Department of Pharmaceutical Sciences, KU Leuven, Belgium [1].

Global settlement clears a pathway for trastuzumab biosimilar

Biosimilars/News | Posted 17/03/2017

Generics giant Mylan Pharmaceuticals (Mylan) announced on 13 March 2017 that it had agreed to the terms of a global settlement with Genentech and Roche in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licences for its trastuzumab biosimilar.

Savings to be made by using etanercept biosimilar in UK

Biosimilars/Research | Posted 17/03/2017

A study of patients taking etanercept to treat rheumatoid arthritis or psoriasis in the UK has shown that there are substantial savings to be made by using the biosimilar [1].

FDA updates Purple Book for biologicals and biosimilars

Biosimilars/General | Posted 10/03/2017

On 21 February 2017, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced the availability of an updated version of the ‘Purple Book’.

Russian approval for non-originator interferon beta-1a

Biosimilars/News | Posted 10/03/2017

Russian biotechnology company Biocad announced on 3 March 2017 that the Russian Ministry of Health had approved the company’s interferon beta-1a non-originator biological drug, BCD-033. The drug is a non-originator biological of Merck’s multiple sclerosis blockbuster Rebif (interferon beta-1a).

Positive results for infliximab biosimilar in Crohn’s disease

Biosimilars/Research | Posted 10/03/2017

Results of a phase III study of Celltrion’s infliximab biosimilar (Remsima; CT-P13) ‘indicate that the safety and efficacy of CT-P13 in patients with moderate-to-severe Crohn’s disease is comparable to those treated with reference infliximab’.

EC approval for first cancer biosimilar Truxima

Biosimilars/News | Posted 03/03/2017

South Korean biotechnology company Celltrion announced on 22 February 2017 that it had received European Commission (EC) approval for the marketing authorization for its rituximab biosimilar Truxima.

Biosimilars of teriparatide

Biosimilars/General | Posted 03/03/2017

Last update: 11 December 2020

Teriparatide is a recombinant form of parathyroid hormone (PTH). Teriparatide is identical to a portion of human PTH and intermittent use activates osteoblasts more than osteoclasts, which leads to an overall increase in bone. This makes it an effective anabolic, i.e., bone growing, agent. It is therefore used for the treatment of osteoporosis in postmenopausal women and men at high risk for fracture and for glucocorticoid-induced osteoporosis in men and postmenopausal women.