Biosimilars
Originator biologicals and biosimilars under attack in UK and Japan
Originator biologicals makers and biosimilars makers are finding themselves facing litigation in both the UK and Japan.
Mass spectrometry comparison of Remicade and Remsima
The US entered the era of biosimilars in 2015 with its very first US Food and Drug Administration (FDA) approved filgrastim biosimilar Zarxio (filgrastim-sndz) [1]. Since then, FDA has approved 11 more biosimilars [2]. Nevertheless, one concern with respect to the manufacturing of biosimilars is that every company has its own proprietary manufacturing process, which could potentially lead to differences in drug properties. Consequently, the debate on how ‘similar’ the biosimilar is to the originator still remains controversial. Thus, a comprehensive but rapid characterization platform that can validate any clinically meaningful differences is required. In this regard, Pisupati et al. [3] carried out a study comparing the reference product Remicade (infliximab) with the first US monoclonal antibody (mAb) biosimilar Remsima (Europe)/Inflectra (US) by incorporating state-of-the-art mass spectrometry-based multiple-attribute monitoring (MAM).
Switching to etanercept biosimilar SB4 safe and effective in a hospital setting
Authors of a study carried out at a UK hospital found switching to etanercept biosimilar SB4 to be safe and effective [1].
FDA reviews adalimumab biosimilar SB5
Samsung Bioepis announced on 27 September 2018 that the regulatory submission for its proposed adalimumab biosimilar (SB5) had been accepted by the US Food and Drug Administration (FDA).
Expediting FDA approvals for biosimilars
A number of recommendations for the US Food and Drug Administration (FDA) to simplify biosimilar licensing laws, and thus make biosimilars more accessible, are offered in a recent review [1]. Recommendations include allowing smaller batch sizes for testing, encouraging substitution for naïve patients, and removing the requirement for bridging studies.
FDA advisers recommend approval of rituximab biosimilar CT-P10
US Food and Drug Administration (FDA) advisers have voted unanimously to recommended approval for CT‑P10, a biosimilar version of Roche’s MabThera/Rituxan (rituximab). If approved by FDA, this would be the first rituximab biosimilar approved in the US.
Phase III trial for subcutaneous Remsima completed
Celltrion Healthcare (Celltrion) announced on 29 August 2018 that it had completed a phase III study with the subcutaneous (SC) version of its infliximab biosimilar Remsima (CT‑P13).
Comments on FDA’s public meeting on biosimilars
Comments made at the US Food and Drug Administration’s (FDA) recent meeting on biosimilars included a call for interchangeability information in the Purple Book, criticism of FDA’s use of arbitrary suffixes and a request to waive bridging studies for biosimilars.
Two darbepoetin alfa biosimilars submitted to Japan’s PMDA
Two South Korean firms have announced that they have submitted applications for approval of their proposed darbepoetin alfa biosmilars to Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA).
Reasons for switching to biosimilars and immunogenicity
Authors from French universities and hospitals discussed the evidence and issues associated with switching from originator biological to biosimilars [1].
