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LG Life Sciences and Mochida make deal for adalimumab biosimilar

South Korea-based LG Life Sciences and Japan-based Mochida Pharmaceutical (Mochida) announced on 15 October 2014 that they had signed a deal to co-develop and commercialize an adalimumab biosimilar for the Japanese market.

Epirus and Livzon collaborate on copy biologicals for China

US-based Epirus Biopharmaceuticals (Epirus) announced on 25 September 2014 that it had signed a collaboration agreement with Chinese biotechnology company Livzon Mabpharm (Livzon).

Infliximab ‘similar biologic’ receives Indian approval

US-based biologicals company Epirus Biopharmaceuticals (Epirus) announced on 15 September 2014 that it had received final marketing and manufacturing approvals for its infliximab similar biologic, BOW015, from the Drug Controller General of India (DCGI).

Mylan starts phase III trials for biosimilar insulin glargine

Generics maker Mylan has started two US phase III clinical trials for a biosimilar version of French drugmaker Sanofi’s diabetes drug Lantus (insulin glargine).

Long-term safety study of biosimilar anti-TNF initiated

The Polish Society of Gastroenterology is starting an observational trial to study the long-term safety of anti-tumour necrosis factor (TNF) antibodies, including biosimilars, in the treatment of inflammatory bowel disease (IBD), according to ClinicalTrials.gov.

Roche updates position on biosimilars

Originator pharma company Roche has updated its position statement on biosimilars, stating that ‘biosimilars are not quite the same’.

Pegteograstim biological approved in South Korea

South Korean biologicals company, Green Cross, announced on 18 August 2014 that it had received marketing authorization from South Korea’s Ministry of Food and Drug Safety (MFDS) for its pegteograstim biological Neurapeg.

European approval for biosimilar insulin

Partners Eli Lilly and Boehringer Ingelheim, announced on 10 September 2014 that they had received European Commission (EC) approval for its biosimilar insulin glargine product Abasria (LY2963016), a first for Europe.

Infliximab biosimilar to be distributed by Mundipharma

Celltrion’s infliximab biosimilar Remsima will be distributed in Belgium, Germany, Italy, Luxembourg, The Netherlands and UK, exclusively by Mundipharma International and its independent associated companies. Remsima is a biosimilar of Johnson and Johnson (J&J) and Merck’s anti-inflammatory blockbuster Remicade (infliximab).

FDA receives application for monoclonal antibody biosimilar

South Korean biotechnology company Celltrion announced on 11 August 2014 that the company had, on 8 August 2014, completed the filing procedure to obtain US Food and Drug Administration (FDA) approval for its infliximab biosimilar.