Biosimilars

IBD barriers: an analysis of Latin America

Biosimilars/Research | Posted 03/10/2023

A comprehensive review conducted by Queiroz et al. in 2023 [1] explores the barriers to accessing IBD care throughout Latin America, a large and diverse region used to describe South America, Central America, Mexico and the islands of the Caribbean. Each one of these regions/countries carries a different cultural and historical background, diverse political systems and a distinct healthcare system.

FDA approves first natalizumab biosimilar Tyruko for MS

Biosimilars/News | Posted 14/09/2023

On 24 August 2023, the US Food and Drug Administration approved Tyruko (natalizumab-sztn) as the first biosimilar to Tysabri (natalizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko is first-of-its-kind biosimilar natalizumab to receive approval in the US.

Ophthalmology biosimilars in Canada: a prescriber’s perspective

Biosimilars/Research | Posted 14/09/2023

The first biosimilar entered the Canadian market in 2009 and the first ophthalmic biosimilar was approved in 2022. Now, a report based on the results of a 2022 survey [1], reveals the views of prescribing ophthalmology physicians in Canada on product identification, prescribing biologicals and prescribing biosimilars and switching.

EMA recommends approval of first natalizumab biosimilar Tyruko for MS

Biosimilars/News | Posted 24/08/2023

On 20 July 2023, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorisation for the medicinal product Tyruko (natalizumab), a biosimilar of reference product Tysabri, intended for the treatment of multiple sclerosis (MS).

Response to Opinion on: Four steps for streamlining biosimilars development

Biosimilars/Research | Posted 17/08/2023

In the Opinion article, 'Biosimilars drug development: time for a paradigm shift?' published in GaBI Journal, the authors question the need for what they consider to be the arduous regulatory requirements for approval of biosimilars [1]. In response to this article, Dr Robin Thorpe, Deputy Editor-in-Chief of the journal has published a rebuttal [2], providing insightful counterpoints to the concerns raised by the authors.

EMA recommends approval of first aflibercept and tocilizumab biosimilars

Biosimilars/News | Posted 10/08/2023

On 20 July 2023, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorisation for the medicinal product Yesafili (aflibercept), an ophthalmology biosimilar, and Tyenne (tocilizumab), an immunosuppressant used largely for treatment of arthritis.

Coherus retracts AbbVie restraining order in Humira biosimilar dispute

Biosimilars/General | Posted 10/08/2023

Coherus BioSciences agreed to retract its restraining order against AbbVie in June 2023, an action taken to prevent AbbVie from terminating its Humira licence deal [1].

Four steps for streamlining biosimilars development

Biosimilars/Research | Posted 03/08/2023

The cost of developing biosimilars can be prohibitively expensive. A manuscript published in GaBI Journal entitled 'Biosimilars drug development: time for a paradigm shift?' [1], explores ways in which we can see leaner and faster biosimilar clinical trials, without compromise on safety and efficacy of the drug products.

Alvotech: rejection AVT02 in the US and new partnerships with Prolifarma and Advanz Pharma

Biosimilars/News | Posted 03/08/2023

The US Food and Drug Administration (FDA) rejected Alvotech’s biologicals licence application (BLA) for their biosimilar adalimumab AVT02 in June 2023. Alvotech has also formed new partnerships with Prolifarma and Advanz Pharma for proposed biosimilars to Eylea (aflibercept) and Xolair (omalizumab), respectively.

Biosimilars: US prescriber’s attitudes and perceptions revealed

Biosimilars/Research | Posted 28/07/2023

A report based on the 2021 survey carried out by the Alliance for Safe Biologic Medicines (ASBM) reveals the views of prescribing physicians, regarding the prescribing, substitution and interchangeability of biosimilars [1].

Proposal to widen access to trastuzumab in New Zealand

Biosimilars/General | Posted 28/07/2023

In New Zealand there has been a proposal to widen access to intravenous trastuzumab from Herceptin to a biosimilar trastuzumab called Herzuma from 1 December 2023.

Coherus: lowest price adalimumab biosimilars announced

Biosimilars/News | Posted 28/07/2023

Coherus BioSciences has announced that it will launch Yusimry, its adalimumab biosimilar, at the lowest price announced to date in the US.

Clinical trial advances for Kashiv and Celltrion

Biosimilars/Research | Posted 24/07/2023

US-based Kashiv Biosciences announced that ADL018, a biosimilar candidate to Xolair (omalizumab), has completed a successful global phase I clinical study in healthy volunteers. In addition, South Korea’s Celltrion announced that it received approval from the US Food and Drug Administration for the phase III investigational new drug (IND) application of its biosimilar CT-P53 for Ocrevus (ocrelizumab), a treatment for multiple sclerosis.

GADECCU position statement on biosimilars updated

Biosimilars/General | Posted 14/07/2023

GADECCU (Grupo Argentino de Enfermedad de Crohn y Colitis Ulcerosa), the Argentine Group for Crohn's Disease and Ulcerative Colitis, after providing key definitions on medical switch, non-medical switch and automatic substitution [1] and considering all the scientific information available, has updated its position in March 2023 regarding the use of biological medicines in clinical practice.

Study investigates success of US ‘skinny label’ approval pathway

Biosimilars/Research | Posted 14/07/2023

Recent court rulings have put the US’ ‘skinny label’ approval pathway at risk. Now, a research letter published in JAMA Internal Medicine [1] has found approval and marketing of skinny label biosimilars have led to billions of dollars in savings to Medicare.

Celltrion: advances for Yuflyma and Vegzelma biosimilars

Biosimilars/News | Posted 20/06/2023

In the first half of 2023, South-Korea based Celltrion Biologics announced the approval of their Yuflyma (adalimumab-aaty) biosimilar in the US, the winning of a bid to supply Italy and Belgium with bevacizumab biosimilar Vegzelma.

Alkem launches first cetuximab similar biologic in India

Biosimilars/News | Posted 13/06/2023

In May 2023, Alkem Oncology announced the launch of Cetuxa, the fist similar biologic of cetuximab used in the treatment of head and neck cancer. The cetuximab originator was developed by Merck and is sold under the brand name Erbitux.

GADECCU presents a new positioning on biosimilars

Biosimilars/General | Posted 13/06/2023

The Argentine Group for Crohn's Disease and Ulcerative Colitis (Grupo Argentino de Enfermedad de Crohn y Colitis Ulcerosa, GADECCU) has released an updated position statement on biosimilars, particularly regarding the alternate use of innovative biological drugs and biosimilars during the same chronic treatment in patients with inflammatory bowel disease.

Low switch-back for patients treated with Avsola for IBD

Biosimilars/Research | Posted 06/06/2023

A study has reported low switch-back rates for patients with inflammatory bowel disease (IBD) switched from the reference infliximab product to Amgen’s biosimilar Avsola (infliximab-axxq), ABP 710 [1].

EMA recommends approval of eculizumab biosimilar Epysqli

Biosimilars/News | Posted 30/05/2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 March 2023 that it had adopted a positive opinion for Epysqli.

Joint statement on biosimilars in immune-mediated diseases in Spain

Biosimilars/General | Posted 30/05/2023

A study conducted and published by Monte-Boquet E et al. aimed to improve knowledge and use of biosimilar medicines in immune-mediated diseases, and to produce a unified framework for the use of biosimilars [1].

High mannose glycans in biosimilars and their pharmacokinetic impact

Biosimilars/Research | Posted 19/05/2023

A study conducted by Welch J et al. assessed the measurement, evaluation and potential for high mannose glycans to impact the pharmacokinetic (PK) profile of biosimilar monoclonal antibodies (mAbs), based on data submitted in 21 applications reviewed and approved by the US Food and Drug Administration (FDA). They also analysed reproducibility data of the glycan values for a subset of programmes within a reference product class. This reproducibility assessment enabled a broader cross-programme comparison of whether observed differences in high mannose between a proposed biosimilar and its reference product translate into PK differences.

New indication for Cosentyx (secukinumab) biological: hidradenitis suppurativa

Biosimilars/News | Posted 19/05/2023

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use adopted a positive opinion on 26 April 2023 recommending Novartis' Cosentyx (secukinumab) to treat active moderate to severe hidradenitis suppurativa (HS) in adults.

An update on the joint EMA-HMA statement on interchangeability of biosimilar

Biosimilars/General | Posted 12/05/2023

On 21 April 2023, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued an updated joint statement on the interchangeability of biosimilars approved in the EU.

Biosimilars in Southern European Hospital Markets: barriers and determinants of uptake

Biosimilars/Research | Posted 12/05/2023

A recent publication by Barcina Lacosta et al. reflected on the need to understand market dynamics generated following biosimilars availability in Southern Europe, emphasizing that the competitive potential of biosimilars can be further deployed [1]. Considering the country-, setting-, and product-specific nature of biosimilar uptake patterns [2-5], the authors focused the analysis on hospital tumour necrosis factor alpha (TNF-α) inhibitor markets in Italy, Portugal and Spain [1].

Advances for STADA-Xbrane’s Ximluci in Europe, the UK and the US

Biosimilars/News | Posted 04/05/2023

The STADA and Xbrane co-developed Ximluci, ranibizumab biosimilar is to launch in Europe and will now also be available on the UK’s National Health Service (NHS). In addition, the partners have submitted their Biologics License Application (BLA) to the US Food and Drug Administration (FDA).

Biosimilars switching policies for Canada’s Newfoundland and Labrador, and Yukon

Biosimilars/General | Posted 04/05/2023

The Canadian provinces of Newfoundland and Labrador, and Yukon, become the 9th and 10th Canadian provinces to announce that they are adopting biosimilars switching policies.

Advancing biosimilar drug development with pharmacodynamic biomarkers

Biosimilars/General | Posted 27/04/2023

US Food and Drug Administration (FDA) researchers are studying the use of pharmacodynamic (PD) biomarkers to demonstrate biosimilarity. These studies could make the process of developing biosimilars more efficient and faster.

Rinvoq approved to treat Crohn’s disease in Europe

Biosimilars/News | Posted 27/04/2023

On 17 April 2022, AbbVie announced that its Rinvoq (upadacitinib) had received European Commission (EC) approval. It is the first and only oral Janus Kinase (JAK) inhibitor approved to treat moderately to severely active Crohn's disease in adult patients. Rinvoq has the potential to rival AbbVie’s own blockbuster drug, Humira (adalimumab) and its biosimilars for inflammatory autoimmune conditions [1].

Using infliximab economic evaluations in IBD to inform biosimilar access policies

Biosimilars/Research | Posted 27/04/2023

According to a recent review, there has been limited economic evaluation of the varying prices of infliximab, despite its high cost. This limitation hinders the ability to understand the potential effects of introducing biosimilars. To ensure that patients with inflammatory bowel disease (IBD) continue to have access to their current medications, alternative pricing strategies and treatment access should be explored [1].

Advances for Henlius’ trastuzumab and bevacizumab biosimilars in the US

Biosimilars/News | Posted 20/04/2023

The US Food and Drug Administration (FDA) accepted Henlius' application for HLX02 (biosimilar trastuzumab for injection). Meanwhile, Henlius' multicentre phase III clinical trial (NCT04740671) of HLX04-O (biosimilar bevacizumab) for wet age-related macular degeneration (wAMD) commenced in the US with the first patient dosed.

Biosimilars and other copies of biological products

Biosimilars/Research | Posted 20/04/2023

The Commentary by Kurki P [1] is a response to the article of Klein et al. [2] that deals with copies of original biotherapeutics, biosimilars and non-biosimilars, marketed in 15 low- and middle-income countries (LMIC).

Spanish Psoriasis Group update biosimilar position statement

Biosimilars/General | Posted 14/04/2023

The use of biosimilar drugs in the treatment of moderate to severe psoriasis has changed the current therapeutic approach. Evidence from clinical trials and real-world experiences has led to an update in the positioning of the Spanish Psoriasis Group (GPS) [1].

US and EC approvals for Hyrimoz, US approval for Udenyca autoinjector

Biosimilars/News | Posted 14/04/2023

In March 2023, the US Food and Drug Administration (FDA) approved Sandoz’s Hyrimoz biosimilar, a citrate-free high-concentration formulation (HCF) of adalimumab, as well as Coherus Biosciences’ (Coherus) innovative single-dose, prefilled autoinjector presentation of Udenyca (pegfilgrastim-cbqv).

Bio-USER survey highlights the perception of retina specialists about biosimilars

Biosimilars/Research | Posted 06/04/2023

The International Biosimilar Retina Study Group (Inter-BIOS Study Group) has recently published the results of the largest survey of biosimilar awareness amongst retina specialists practicing in the US and Europe [1]. The Survey was targeted at 200 retina specialists (100 from the US and 100 from Europe) and 112 retina specialists (55 from the US and 57 from Europe) responded. These results were presented at the 22nd Euretina Congress held in Hamburg, Germany [2], and also at the American Academy of Ophthalmology 2022 Annual Meeting held in Chicago, USA [3]. Following were the major findings of this survey:

First African developed biosimilar adalimumab starts phase I trial in Germany

Biosimilars/News | Posted 06/04/2023

A phase I clinical trial of Minapharm Pharmaceuticals’ first African developed adalimumab biosimilar, Adessia, was initiated on 24 February 2023 in Germany with results to be expected at the end of 2023.

Biosimilar launches in Canada and US: Byooviz and Stimufend

Biosimilars/News | Posted 31/03/2023

In Canada, Biogen announced that their Byooviz (ranibizumab) injection, a biosimilar of Lucentis, is available as of March 2023. In the preceding month, Fresenius Kabi launched Stimufend (pegfilgrastim-fpgk), a biosimilar of Amgen’s Neulasta, in the US.