Biosimilars/News
Epirus starts phase III trial for infliximab biosimilar
US-based biologicals company Epirus Biopharmaceuticals (Epirus) announced on 9 February 2016 that it had started a phase III trial for its infliximab biosimilar (BOW015).
Trastuzumab non-originator biological approved in Russia
Russian biotechnology company Biocad announced on 20 January 2016 that the Russian Ministry of Health had approved the company’s trastuzumab non-originator biological, BCD-022. The drug is a non-originator biological of Roche’s breast cancer blockbuster Herceptin (trastuzumab).
FDA advisers recommend approval of Celltrion’s infliximab biosimilar
US Food and Drug Administration’s (FDA) advisers have voted to recommend the approval of Celltrion’s biosimilar version of Johnson & Johnson and Merck’s arthritis treatment Remicade (infliximab).
EMA accepts application for pegfilgrastim biosimilar
Sandoz, the generics division of Novartis, announced on 11 February 2016 that its regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the European Medicines Agency (EMA).
Kyowa to market Sandoz’s rituximab biosimilar in Japan
Biotech firm Kyowa Hakko Kirin (Kyowa) announced on 25 January 2016 that it had made a deal with Sandoz, the generics division of Novartis, for exclusive marketing rights to Sandoz’s biosimilar rituximab in Japan.
Australian approval for infertility biosimilar Bemfola
Switzerland-based Finox Biotech (Finox) announced on 30 November 2015 that it had gained approval from Australia’s drug regulator, the Therapeutic Goods Administration (TGA), for follitropin alfa biosimilar Bemfola.
Filgrastim follow-on biological approved in Brazil
Brazil’s medicines agency, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), announced on 20 October 2015 that it had approved the follow-on biological medicine Fiprima (filgrastim).
Bevacizumab non-originator biological approved in Russia
Russian biotechnology company Biocad announced on 30 November 2015 that the Russian Ministry of Health had approved the company’s bevacizumab non-originator biological drug, BCD-021. The drug is a non-originator biological of Roche’s cancer blockbuster Avastin (bevacizumab).
EMA accepts application for etanercept biosimilar
Sandoz, the generics division of Novartis, announced on 8 December 2015 that the regulatory submission for its proposed etanercept biosimilar (GP2015) had been accepted by the European Medicines Agency (EMA).
FDA approves first follow-on insulin glargine treatment
The US Food and Drug Administration (FDA) announced on 16 December 2015 that it had approved Eli Lilly/Boehringer Ingelheim’s biosimilar version of Sanofi’s Lantus (insulin glargine) diabetes treatment.
