Biosimilars/News
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.
Merck KGaA to invest Euros 100 million in biosimilars
Germany’s Merck KGaA is looking for new sources of growth, one of which it sees as being biosimilars.
FDA grants tentative approval for insulin treatment
On 18 August 2014, the US Food and Drug Administration (FDA) granted tentative approval for a new insulin glargine product (LY2963016).
More biosimilars collaborations on the cards
Collaborations for biosimilars are still in vogue, with the latest companies making deals being PlantForm Corporation (PlantForm) with PharmaPraxis and Oncobiologics and Laboratorios Liomont.
Epirus and Ranbaxy sign agreement for infliximab 'similar biologic'
Epirus Switzerland, a subsidiary of US-based Epirus Biopharmaceuticals, and India-based Ranbaxy Laboratories (Ranbaxy) announced on 9 January 2013 that the two companies had signed a licensing agreement for BOW015, an infliximab biosimilar.
FDA accepts applications for three-times-weekly follow-on Copaxone
The US Food and Drug Administration (FDA) has accepted applications submitted by generics makers Dr Reddy’s, Sandoz (Momenta Pharmaceuticals’ development and commercialization partner), and Mylan for three-times-weekly follow-on versions of blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).
Coherus starts phase III biosimilar etanercept trial
US-based biosimilars developer Coherus BioSciences (Coherus) announced on 23 June 2014 the start of a global phase III trial for a biosimilar version of etanercept.
Biosimilar infliximab receives approval in Japan and Turkey
South Korean biotechnology company Celltrion announced on 4 and 16 July 2014 that the company had received marketing approval for its biosimilar Remsima (infliximab) in Japan and Turkey, respectively.
