Biosimilars
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.
How safe is Zarzio after five years’ clinical experience?
The first filgrastim biosimilar was approved in Europe in 2008, prompting Dr Pere Gascón and co-authors to review the evidence relating to the efficacy and safety of biosimilar Zarzio (filgrastim) and Filgrastim Hexal (filgrastim) since that time. The authors report a pooled analysis of post-approval studies of Zarzio (Sandoz) used for the prevention of neutropenia in patients with cancer who are undergoing cytotoxic chemotherapy [1].
Amgen starts another phase III trial for biosimilar adalimumab
US biotechnology giant Amgen has started recruiting for a phase III clinical trial of its biosimilar adalimumab in patients suffering from plaque psoriasis, according to the US clinical trials website, Clinicaltrials.gov.
Biosimilars approved in South Korea
Last update: 26 March 2021
In South Korea, the regulatory body for the approval of medicines, including biologicals and biosimilars, is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration.
Protein aggregation and the generation of immune responses
During a presentation given by Ms Melody Sauerborn (TNO Triskelion, The Netherlands) at an international conference on biowaivers and biosimilars, held in the US in September 2012, the immunological aspects of formation of anti-drug antibodies against aggregated protein drugs were discussed [1].
Biosimilar epoetin-κ equivalent to epoetin-β
In 1989, the first recombinant erythropoietin (rEPO) preparation, epoetin-α, was approved by the US Food and Drug Administration for the treatment of anaemia associated with kidney disease. Since then, several clinically approved rEPO preparations, such as epoetin-β, epoetin-δ and the epoetin-α derivative, darbepoietin-α, have been commercially produced. Since the expiration of patent protection, a number of biosimilars have also been approved on the world market.
Biosimilars approved in Japan
Last update: 24 October 2023
In Japan, the regulatory body for the approval of medicines, including biologicals, is the Ministry for Health Labour and Welfare (MHLW).
Kissei makes biosimilars deal with Alteogen
Japan-based Kissei Pharmaceutical (Kissei) announced on 13 February 2014 that the company had entered into a collaboration agreement with South Korean biologicals company Alteogen.
EU majority says same INNs for biosimilars
According to recently published summary minutes from an October 2013 meeting of the European Commission’s Pharmaceutical Committee, the majority of EU Member States agree that biosimilars should have the same international non-proprietary name (INN) as their reference biological.
