Biosimilars/News
Samsung Bioepis submits second biosimilar to EMA
South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 13 March 2015 that its infliximab biosimilar candidate, SB2, had been accepted for review by the European Medicines Agency (EMA).
Biosimilar etanercept submitted for approval in EU
South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 21 January 2015 that its etanercept biosimilar candidate, SB4, had been accepted for review by the European Medicines Agency (EMA).
Biogen and Samsung make deal for marketing anti-TNF biosimilars
US biotechnology company Biogen Idec (Biogen) and Korean electronics giant Samsung announced on 17 December 2013 that Biogen has exercised its right to enter into an agreement to commercialize anti-tumour necrosis factor (TNF) biosimilar product candidates in Europe.
Trials to start for biosimilar infliximab and etanercept
Pfizer is to start a phase I study for its biosimilar infliximab candidate (PF-06438179) and Samsung Bioepis has initiated a phase III clinical trial for its biosimilar etanercept (SB4), according to entries on the US and EU clinical trials websites.
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).
