Biosimilars/News
BioOutsource launches ready-to-use biosimilarity assays
Sartorius Stedim BioOutsource (BioOutsource), a subsidiary of Sartorius Stedim Biotech, has launched a range of ready-to-use assays for testing biosimilarity. The assays are available for biosimilars of Hoffmann–La Roche/Chugai’s rheumatoid arthritis treatment Actemra (tocilizumab), Centocor’s psoriasis treatment Stelara (ustekinumab) and Novartis/Genentech’s age-related macular degeneration drug Lucentis (ranibizumab).
FDA approves infliximab biosimilar Inflectra
The US Food and Drug Administration (FDA) announced on 5 April 2016 that it had approved the country’s second biosimilar Inflectra (infliximab).
Biocon receives Japanese approval for insulin glargine biosimilar
India-based biologicals specialist Biocon announced on 28 March 2016 that it had received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its insulin glargine biosimilar.
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).
