Biosimilars

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.