Biosimilars
Insulin glargine biosimilars launched in UK and South Korea
November 2018 has seen the launch of insulin glargine biosimilars in both the UK and South Korea.
Tanvex BioPharma submits filgrastim biosimilar to FDA
Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) announced on 1 October 2018 that it had submitted its first biosimilar application to the US Food and Drug Administration (FDA). The application is for its proposed filgrastim biosimilar TX01.
Positive phase III data for adalimumab biosimilar Cyltezo
Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) announced on 12 September 2018 positive phase III data for its adalimumab biosimilar, Cyltezo [1]. The results, according to Boehringer Ingelheim ‘confirm that Cyltezo is equivalent to Humira, with no clinically meaningful differences in efficacy safety and immunogenicity in people with moderate-to-severe chronic plaque psoriasis’.
Another adalimumab copy biological accepted for review in China
The China National Drug Administration (CNDA), formerly the China Food and Drug Administration (CFDA) has accepted another application for approval of an adalimumab copy biological, this time from Innovent Biologics (Innovent).
Phase I study suggests similarity of omalizumab biosimilar
Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 25 July 2018 that results from a phase I study suggest similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles between Glenmark’s proposed omalizumab biosimilar GBR 310 and the originator product Xolair (omalizumab).
FDA approves adalimumab and pegfilgrastim biosimilars
The US Food and Drug Administration (FDA) announced on 30 October 2018 and on 2 November 2018 that it had approved adalimumab and pegfilgrastim biosimilars, respectively.
Inflectra may not be less expensive than Remicade in US
According to research carried out in the US, the cost of the infliximab biosimilar Inflectra (infliximab-dyyb) was only moderately less expensive than the originator biological Remicade (infliximab) in treating rheumatoid arthritis (RA) and exceeded US$14,000 annually under Medicare# Part D*. In addition, out-of-pocket costs for patients taking Inflectra may be more than US$1,700 higher than for patients taking Remicade.
Phase III study of biosimilar pegfilgrastim confirms safety and effectiveness in patients on myelosuppressive chemotherapy
Canada-based Apobiologix, a division of Apotex, reported results of an international, phase III, randomized, double-blind clinical trial to demonstrate biosimilarity between the Apotex pegfilgrastim biosimilar (Apo-Peg; Lapelga) and reference product Neulasta (Amgen) [1].
Adalimumab biosimilars Amgevita and Imraldi launched in Europe
In October 2018, two adalimumab biosimilars have been launched in the European Union (EU). Amgen announced the European launch of its adalimumab biosimilar, Amgevita and Biogen announced the launch of its adalimumab biosimilar Imraldi.
Clinical and real-world data for switching to biosimilars
The evidence and issues associated with switching from originator biological disease-modifying antirheumatic drugs (DMARDs) to biosimilars are discussed by authors from French universities and hospitals [1].
