Biosimilars

Increasing access to biosimilars and generics in Europe

Biosimilars/General | Posted 14/04/2017

On 2 March 2017, the European Parliament voted on a resolution to strike a better balance between European Union (EU) countries’ public health interests and those of the pharmaceutical industry.

Basal analogue insulin ‘copy biological’ launched in Indonesia

Biosimilars/News | Posted 07/04/2017

Indonesian generics maker Kalbe Pharma (Kalbe) announced on 25 March 2017 the launch of a basal analogue insulin ‘copy biological’ in Indonesia.

Filgrastim follow-on biological has similar efficacy and safety in breast cancer patients

Biosimilars/Research | Posted 07/04/2017

A study comparing two filgrastim formulations for controlling chemotherapy-induced neutropenia has reported similar efficacy, safety and non-inferiority of the biosimilar [1].

Amgen at the centre of biosimilars disputes

Biosimilars/General | Posted 07/04/2017

The disputes involve a biosimilar of Amgen’s biosimilar of Roche’s Avastin (bevacizumab) and Amgen’s blockbuster Neulasta (pegfilgrastim) being made by Coherus Biosciences.

Marketing authorization for NBCDs in the EU

Biosimilars/Research | Posted 07/04/2017

The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU and this also includes non-biological complex drugs (NBCDs).

EC approval for adalimumab biosimilar Amgevita

Biosimilars/News | Posted 31/03/2017

Biotech giant Amgen announced on 23 March 2017 that the European Commission (EC) had granted marketing authorization for its adalimumab biosimilar Amgevita.

The European Pharmacopoeia monographs for biotherapeutic products

Biosimilars/Research | Posted 31/03/2017

European Pharmacopoeia (Ph. Eur.) monographs for biologicals have existed since the 1990s and remain the publicly available standard defining the quality of these medicines. Continued development of such monographs, however, faces considerable challenges and the value and utility of these monographs have been questioned in recent years. What such challenges are and how they can be overcome is discussed by Head of Division of the European Pharmacopoeia Department at the EDQM, Dr Emmanuelle Charton, in a GaBI Journal paper [1].

FDA biologicals naming guidance could cost providers billions

Biosimilars/General | Posted 31/03/2017

Healthcare organizations have expressed their ‘grave concerns’ over the ‘enormous financial consequences’ of the US Food and Drug Administration’s (FDA) guidance on naming of biologicals.

Amgen submits trastuzumab biosimilar to EMA

Biosimilars/News | Posted 24/03/2017

Biotech giant Amgen announced during a conference presentation that it had filed for marketing approval for its trastuzumab biosimilar (ABP 980) in the European Union (EU).

Study of top-down infliximab use in children with Crohn’s disease

Biosimilars/Research | Posted 24/03/2017

The Erasmus Medical Center, in collaboration with the Netherlands Organisation for Health Research and Development and biosimilars maker Hospira, now Pfizer, is carrying out a study to investigate the benefits and risks of the use of infliximab as first-line use for children with active perianal fistulising Crohn’s disease [1].

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.