Biosimilars

Canada’s Saskatchewan province introduces biosimilars switching policy

Biosimilars/General | Posted 04/11/2022

The Canadian province of Saskatchewan is the latest to introduce a biosimilars switching policy. As of October 2022, the province joins British Columbia (BC) [1], Quebec [2], Alberta, Ontario [3], New Brunswick [4], Nova Scotia [5], and the Northwest Territories [6] in introducing biosimilars switching policies.

Progress for Lucentis (ranibizumab) biosimilars in Europe and the US

Biosimilars/News | Posted 28/10/2022

On 16 September 2022, Partners Stada Arzneimittel and Xbrane Biopharma announced that the European Medicines Agency’S (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Ximluci, a biosimilar candidate referencing Lucentis (ranibizumab). In addition, on 19 September 2022 in the US, Coherus BioSciences announced that from 3 October 2022, another ranibizumab biosimilar, Cimerli (ranibizumab-eqrn) will be commercially available.

Switching from adalimumab originator and ABP501 to SB5 in arthritis patients

Biosimilars/Research | Posted 28/10/2022

The introduction and availability of biosimilars entails a considerable increase in the patient access as well as a decrease in the patient cost. Thus, biosimilars could be the answer to the economic impact of the reference biological.

A Canadian gastro-enterologist’s view on advising on biosimilars

Biosimilars/General | Posted 28/10/2022

Acting as a ‘trusted advisor’ when answering questions about biological and biosimilar products is important for Canadian physician, Dr Dustin Loomes reported in a recent article.

Bevacizumab biosimilar approvals and launch in Japan and USA

Biosimilars/News | Posted 21/10/2022

On 27 and 28 September 2022, Celltrion announced that its oncology biosimilar bevacizumab, Vegzelma, has been approved in Japan and the US. In October 2022, Amneal Pharmaceuticals, also announced the launch of Alymsys (bevacizumab-maly) in the US.

Updates for European Pharmacopoeia monographs for biotherapeutic products

Biosimilars/Research | Posted 21/10/2022

The European Pharmacopoeia produces monographs for biotherapeutic products that are publicly available and considered the standard for defining the quality of these medicines. A recent study published in GaBI Journal [1] examines whether the challenges posed by complex products such as the introduction of biosimilars, have been met by new elements that have been added to the monographs.

Forwards for Formycon’s Keytruda and backwards for Prestige’s Herceptin

Biosimilars/News | Posted 14/10/2022

On 19 September 2022, Formycon announced details of a project to produce a biosimilar of Keytruda (pembrolizumab). This followed news that, on 16September 2022, Prestige Biopharma withdrew the Marketing Authorization Application (MAA) for their Herceptin Biosimilar, Tuznue, submitted to the European Medicines Agency (EMA).

Biosimilars of pembrolizumab

Biosimilars/General | Posted 14/10/2022

Pembrolizumab is a humanized (from mouse) monoclonal antibody that binds to, and blocks PD-1 located on lymphocytes. It is an anticancer medication used in the treatment of melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, urothelial cancer (cancer of the bladder and urinary tract) and renal cell carcinoma (kidney cancer).

FDA approves biosimilar pegfilgrastim Stimufend

Biosimilars/News | Posted 06/10/2022

On 6 September 2022, Fresenius Kabi announced that they had received approval from the US Food and Drug Administration (FDA) for their pegfilgrastim biosimilar, Stimufend (pegfilgrastim-fpgk).

Recommendations for improving biosimilar regulations in Latin America

Biosimilars/Research | Posted 06/10/2022

The biosimilar regulatory scenario is very diverse and varies widely in the large group of Latin American countries. Authors Teran et al. presented some recommendations for making biosimilar regulations in Latin America more homogeneous and comprehensive [1].

Successful trials for Sandoz and Lannett biosimilars

Biosimilars/Research | Posted 30/09/2022

On 19 September 2022, Sandoz announced positive results following its ROSALIA I/III clinical trial study for its proposed biosimilar denosumab. This follows the August announcement that Lannett Company successfully completed subject dosing in the clinical trial of its biosimilar insulin glargine.

EMA calls for biosimilar interchangeability across the EU

Biosimilars/General | Posted 23/09/2022

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued on 19 September 2022 a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar. This will allow more patients to have access to biological medicines necessary for treating diseases such as cancer, diabetes and rheumatic diseases.

Recommendations to address challenges to biosimilars in Latin America

Biosimilars/Research | Posted 23/09/2022

After reviewing the regulatory landscape for biosimilars [1] and access to biosimilars for cancer treatments in Latin America [2], authors Teran et al. advised several recommendations to address challenges related to poor access to biosimilars in Latin America healthcare systems.

EC approves bevacizumab biosimilar Vegzelma

Biosimilars/News | Posted 23/09/2022

On 18 August 2022, South Korea-based biologicals specialist Celltrion announced that its bevacizumab biosimilar, Vegzelma (CT-P16), had received European Commission (EC) approval.

EC approves ranibizumab biosimilar Ranivisio

Biosimilars/News | Posted 16/09/2022

On 29 August 2022, the ranibizumab biosimilar Ranivisio (FYB201), developed by Bioeq – a joint venture between Formycon and Polpharma Biologics, was granted marketing approval by the European Commission (EC).

FDA accepts application for high concentration adalimumab biosimilar

Biosimilars/News | Posted 16/09/2022

Sandoz, the generics division of Novartis, announced on 21 July 2022 that the US Food and Drug Administration (FDA) had accepted the supplemental biologics license application for the high concentration formulation (HCF) of its adalimumab biosimilar Hyrimoz (GP2017) (adalimumab-adaz).

Applications for natalizumab biosimilars accepted by FDA and EMA

Biosimilars/News | Posted 09/09/2022

Applications for natalizumab biosimilars made by Sandoz (the generics division of Novartis) and Polpharma Biologics (Polpharma) have been accepted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Regulatory landscape for biosimilars in Latin America

Biosimilars/Research | Posted 09/09/2022

The biosimilar regulatory situation in Latin America varies broadly among the different countries, even though Latin America is moving towards consolidating defined and standardised regulatory pathways for these products. This article gives a summary of the biosimilar regulatory status for the countries represented by members of the panel of experts of the American Health Foundation (AHF). The countries reviewed are Chile, Colombia, Ecuador, Guatemala and Peru [1].

Totality of evidence for biosimilar pegfilgrastim Ziextenzo

Biosimilars/Research | Posted 09/09/2022

Agarwala et al. have recently published a review on the totality of evidence (ToE) for the biosimilar pegfilgrastim Ziextenzo® (LA-EP2006) matching the European Union- (EU) and US-reference biological pegfilgrastim Neulasta® (marketed by Amgen) [1].

FDA accepts application for tocilizumab biosimilar

Biosimilars/News | Posted 02/09/2022

Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 1 August 2022 that the US Food and Drug Administration (FDA) had accepted the application for their proposed tocilizumab biosimilar (MSB11456).