Biosimilars
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].
Merck gains US infliximab contract but drops insulin glargine biosimilar
US pharma giant Merck (known as MSD outside the US and Canada) has signed a deal with the US Department of Veterans Affairs (VA) for its infliximab biosimilar, Renflexis. However, it is pulling out of a deal for insulin glargine biosimilar Lusduna.
Real-life clinical effectiveness of Razumab in retinal vein occlusion
Authors from Intas Pharmaceuticals presented data from a subgroup analysis of the RE-ENACT study (retrospective, multicentre, observational pooled study on wet age-related macular degeneration [wet AMD], diabetic macular oedema, and retinal vein occlusion) [1]. The RE-ENACT study evaluated the effectiveness of the ranibizumab similar biologic Razumab in Indian patients with retinal vein occlusion (RVO).
Trastuzumab similar biologic Hervycta launched in India
India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 26 July 2018 the launch of its product Hervycta, a ‘similar biologic’ of trastuzumab, in India.
Mylan gains nod for Ogivri and launches Hulio in Europe
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced at its meeting on 18 October 2018 that it had recommended granting marketing authorization for the trastuzumab biosimilar Ogivri.
