Biosimilars
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.
WHO investigates use of a biological qualifier for biosimilars
The World Health Organization is still discussing several different options on how to name biosimilars, according to the recently published executive summary of its 57th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances.
Quality by design for biosimilars
A study into the use of quality by design (QbD) has demonstrated how risk management can facilitate the implementation of QbD in the early-stage product development of biosimilars [1].
Celltrion starts phase III biosimilar trastuzumab trial
South Korean biotechnology company Celltrion is starting a phase III clinical trial for its biosimilar trastuzumab candidate (CT-P6) in patients with human epidermal growth factor receptor 2-positive (HER2+) early breast cancer, according to the European Union’s Clinical Trials Register.
Cost savings to be made by switching to Zarzio
Since the first filgrastim biosimilar was approved in 2008, there is now five years of data on which to assess the efficacy, safety and cost-effectiveness of biosimilar granulocyte colony-stimulating factors (G-CSFs). A pooled analysis of post-approval studies of one of the most common biosimilar G-CSFs, Zarzio (filgrastim), is presented by Pere Gascón and co-authors [1]. Their findings highlight significant cost savings in health authority regions that have switched from the originator G-CSF to its biosimilar Zarzio. The study overturns early concerns that cost savings would not be so great as hoped [2].
Alvotech and Finesse enter into biosimilars collaboration
Iceland-based biopharmaceutical company Alvotech and US-based bio-process management company Finesse Solutions (Finesse) announced on 14 March 2014 that they had entered into a partnership for bio-manufacturing.
Biosimilar filgrastim gains Japanese approval
Sandoz (the generics unit of Novartis) announced on 24 March 2014 that its subsidiary Sandoz Japan had received marketing authorization approval for its biosimilar filgrastim (Filgrastim BS Sandoz).
Are biosimilars worth it?
Will off-patent biological medicines offer the same cost savings as those seen with off-patent non-biological (chemically derived) medicines? A group of health economists based in Brussels, Belgium, have begun to address the question in light of increasing numbers of biological medicines going off patent and the new phenomenon of biosimilar competition [1].
GPhA proposes using manufacturer names to distinguish biosimilars
The Generic Pharmaceutical Association (GPhA) has proposed a compromise naming scheme for biosimilars that it hopes will end the dispute over how to assign international non-proprietary names (INNs) to biosimilars in the US.
Long-acting G-CSF lipegfilgrastim launched in UK
Teva UK, a subsidiary of generics giant Teva Pharmaceutical Industries (Teva) announced on 24 February 2014 the launch of its long-acting granulocyte colony-stimulating factor (G‑CSF) Lonquex (lipegfilgrastim) in the UK.
