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Pegfilgrastim biosimilar Lapelga approved in Canada posted 22/05/2018

Canada-based Apotex received approval for its pegfilgrastim biosimilar, Lapelga, from Health Canada with positive decision ma...

FDA approves epoetin alfa biosimilar Retacrit posted 18/05/2018

The US Food and Drug Administration (FDA) approved its first epoetin alfa biosimilar on 15 May 2018.

Biosimilar etanercept Eucept approved in South Korea posted 11/05/2018

South Korea-based LG Chem has obtained regulatory approval to begin marketing and selling its etanercept biosimilar in Korea.

FDA rejects trastuzumab and rituximab biosimilars posted 04/05/2018

US pharma giant Pfizer announced on 23 April 2018 that the US Food and Drug Administration (FDA) had rejected its application...

Australia approves rituximab biosimilar Truxima posted 27/04/2018

South Korean biotechnology company Celltrion announced on 23 April 2018 that Australia’s regulatory body, the Therapeutic Goo...

 

Research

Brazilian oncologists favour ‘follow-on biological products’ posted 18/05/2018

The Brazilian Society of Clinical Oncology (SBOC) has issued a position statement on ‘follow-on biological products’ in oncol...

AA010968 Secrecy is an obstacle to the use of biosimilars in the US posted 17/05/2018

Factors that Professor Frank believes may be affecting uptake include naming and interchangeability guidance, insurance payme...

Safety of biosimilar infliximab in pregnant women with IBD posted 17/05/2018

Introduction of the first biosimilar infliximab (CT‑P13, Remsima/Inflectra) for the treatment of inflammatory bowel diseases...

16704526_l Insurance payment arrangements are an obstacle to biosimilars use in the US posted 17/05/2018

The slow development of the market competition for biosimilars in the US may be caused by several factors, according to Profe...

Biosimilars in rheumatology: the current state of play posted 17/05/2018

Biological disease modifying anti-rheumatic drugs (bDMARDs) have revolutionized the management of rheumatoid arthritis (RA) a...

 

General

Biosimilars approved in Canada posted 18/05/2018

Last update: 18 May 2018In Canada, the regulatory body for the approval of biologicals is the Biologics and Genetic Ther...

Biosimilars approved in the US posted 18/05/2018

Last update: 18 May 2018In the US, a legal framework for approving biosimilars was established in 2009, via the Biologic...

18794124_l Biosimilars highlights for 2017 posted 11/05/2018

There are many product launches and various topics such as naming, extrapolation, interchangeability and switching of biosimi...

AbbVie and Samsung Bioepis reach patent deal over Humira biosimilar posted 04/05/2018

Biosimilars maker Samsung Bioepis announced on 5 April 2018 that it had reached a ‘global resolution’ with pharma giant AbbVi...

Biosimilars of cetuximab posted 17/04/2018

Last Update: 13 April 2018Cetuximab is a chimeric (mouse/human) monoclonal antibody. It inhibits epidermal growth factor...