Biosimilars/General

Biosimilars applications under review by EMA – January 2021

Biosimilars/General | Posted 15/01/2021

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Biosimilars of pegfilgrastim

Biosimilars/General | Posted 31/10/2014

Last update: 15 January 2021

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

Biosimilars of trastuzumab

Biosimilars/General | Posted 19/09/2014

Last update: 15 January 2021

Trastuzumab is a monoclonal antibody that binds to and inactivates the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancers, HER2 is over-expressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat HER2 positive (HER2+) breast cancers.

Biosimilars in Australia – a-flagging and sustainability

Biosimilars/General | Posted 08/01/2021

Australia first introduced guidelines for biosimilars back in August 2008 when it adopted a number of guidelines from the EU on similar biological medicinal products [1].

Biosimilars of rituximab

Biosimilars/General | Posted 27/02/2015

Last update: 8 January 2021

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.

Biosimilar advances for Samsung Bioepis

Biosimilars/General | Posted 11/12/2020

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) has announced several advances related to its infliximab, denosumab and ranibizumab biosimilars. These announcements come after the company revealed soaring sales figure in Europe.

Biosimilars of denosumab

Biosimilars/General | Posted 23/02/2018

Last update: 11 December 2020

Denosumab is a humanized monoclonal antibody that is an inhibitor of the receptor activator of nuclear factor kappa-B ligand (RANKL), which works by preventing the development of osteoclasts which are cells that break down bone. It is used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone and giant cell tumour of bone.

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.

Genentech sues Centus over Avastin biosimilar

Biosimilars/General | Posted 04/12/2020

Genentech Inc. filed a complaint against Centus in the United States (US) state of Texas on 15 November 2020. It is alleged that Centus’s Equidacent, a biosimilar to Genentech’s Avastin (bevacizumab), infringes 10 US patents.

Biosimilars of ranibizumab

Biosimilars/General | Posted 30/10/2015

Last update: 4 December 2020

Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Ranibizumab inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A), a mechanism similar to bevacizumab [1].