Biosimilars/General

Spanish associations sign biosimilars collaboration

Biosimilars/General | Posted 22/06/2018

The Spanish Association of Biosimilar Medicines (BioSim) announced on 21 March 2018 that BioSim and the Federation of Spanish Medical Scientific Associations (FACME) have signed a collaboration agreement that includes the creation of a joint working group to share up-to-date information on biosimilars.

WuXi Biologics expands its biologicals manufacturing facilities

Biosimilars/General | Posted 15/06/2018

China-based WuXi Biologics, headquartered in Wuxi city of Jiangsu Province, is expanding its biologicals manufacturing capacity with new facilities planned in Ireland, China, Singapore and the US.

Biosimilars highlights for 2017

Biosimilars/General | Posted 11/05/2018

There are many product launches and various topics such as naming, extrapolation, interchangeability and switching of biosimilars in 2017 [1]. Important milestones achieved during 2017 were the biosimilar approvals of Renflexis (infliximab-abda), Cyltezo (adalimumab-adbm), Mvasi (bevacizumab-awwb), Ixifi (infliximab‑qbtx), and Ogivri (trastuzumab-dkst), along with the approval of follow-on insulin lispro biological Admelog, by the US Food and Drug Administration (FDA).

Biosimilars of cetuximab

Biosimilars/General | Posted 14/08/2014

Last Update: 13 April 2018

Cetuximab is a chimeric (mouse/human) monoclonal antibody. It inhibits epidermal growth factor receptor (EGFR) and is used to treat metastatic colorectal cancer, metastatic non-small cell lung cancer and head and neck cancer.

US drug contracting system is ‘rigged’ against biosimilars

Biosimilars/General | Posted 16/03/2018

US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb has said that the drug contracting system in the US is ‘rigged’ against biosimilars. His remarks came during a speech he made on 7 March 2018 at the America’s Health Insurance Plans National Health Policy Conference in Washington DC.

Cadila and Kalbe advancing biosimilar ambitions

Biosimilars/General | Posted 09/03/2018

Indian generics maker Cadila Healthcare (Cadila) and Indonesia-based Kalbe Farma (Kalbe) are both making advances into the biosimilars field.

Biosimilars of pegaspargase

Biosimilars/General | Posted 30/06/2017

Pegaspargase is a modified enzyme. It is a form of L-asparaginase which has undergone PEGylation. It is used as an anticancer (‘antineoplastic’ or ‘cytotoxic’) chemotherapy drug. It is indicated for the treatment of acute lymphocytic leukaemia (ALL), non-Hodgkin’s lymphoma and for treatment of patients who have had a hypersensitivity reaction to another form of asparaginase.

Biosimilars of certolizumab pegol

Biosimilars/General | Posted 21/04/2017

Certolizumab pegol is a monoclonal antibody directed against tumour necrosis factor-alfa (TNF-α). More precisely, it is a PEGylated Fab’ fragment of a humanized TNF inhibitor monoclonal antibody. It is indicated for the treatment of Crohn’s disease, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

Brazilian oncologists favour ‘follow-on biological products’

Biosimilars/General | Posted 18/05/2018

The Brazilian Society of Clinical Oncology (SBOC) has issued a position statement on ‘follow-on biological products’ in oncology. The statement reflects the society’s views on issues such as naming, labelling, safety and efficacy, extrapolation of indications, interchangeability, switching and substitution of ‘follow-on biological products’, as well as on the potential impact ‘follow-on biological products’ may have on the financial burden in health care [1].

Spanish gastroenterologists update biosimilar position statement

Biosimilars/General | Posted 30/03/2018

The Spanish Society of Gastroenterology (Sociedad Española de Patología Digestiva,SEPD) has updated its position statement on the use of biosimilars for inflammatory bowel disease (IBD) [1]. The changes in the society’s position reflect the increasing body of evidence supporting the safety and efficacy of biosimilars.