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Biosimilars/Research

Interchangeability V18K30

Biosimilars in inflammatory bowel disease: are we ready for multiple switches

Biosimilars/Research | Posted 13/08/2024

A review by Teixeira FV et al. discusses whether scientific evidence is sufficient to support multiple switches between biologicals and biosimilars in patients with inflammatory bowel diseases (IBD) [1].

TNFa Crystal Structure V18K17

Topline results from clinical development programme for candidate biosimilar AVT05 golimumab

Biosimilars/Research | Posted 23/07/2024

In April and June 2024, Icelandic biosimilar company Alvotech announced promising results from two clinical studies (AVT05-GL-P01, NCT05632211; AVT05-GL-C01, NCT05842213) for AVT05, their candidate golimumab biosimilar. Alvotech is the first company to announce topline results of clinical trials using a proposed biosimilar to Simponi (Janssen Biotech).

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Efficacy and safety of the proposed P043 (Zerafil) vs reference omalizumab in allergic asthma

Biosimilars/Research | Posted 09/07/2024

In June 2024, the results of a phase III clinical trial of P043/Zerafil (omalizumab), a proposed biosimilar of Novartis’ Xolair produced by CinnaGen in Iran, showed no significant difference in efficacy and safety parameters to the originator.

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Tocilizumab and pembrolizumab biosimilar advances for Korean firms

Biosimilars/Research | Posted 03/07/2024

In June 2024, Celltrion announced promising results from their phase III study for CT-P47, a biosimilar candidate of RoActemra (tocilizumab), in patients with rheumatoid arthritis (RA). Additionally, the company has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for the phase III clinical trial of CT-P51, its Keytruda (pembrolizumab) biosimilar. This announcement follows the news that in April 2024, rival Korean biologicals company Samsung Bioepis initiated a phase III clinical trial for SB27, their pembrolizumab biosimilar.

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Unveiling key clinical findings for denosumab biosimilar candidates

Biosimilars/Research | Posted 07/05/2024

In April 2024, Henlius Biotech and Organon announced that the phase III comparative clinical trial for their investigational denosumab biosimilar (HLX14) met the primary endpoints. This follows the news released earlier in the year, that Alvotech and Polpharma achieved positive topline results from their pharmacokinetic (PK) studies for their denosumab biosimilar candidate (AVT03). The originator product is Amgen’s Prolia/Xgeva.

Pharmacokinetics 1 V13K15

Topline results for Polpharma Biologics’ vedolizumab biosimilar candidate

Biosimilars/Research | Posted 16/04/2024

In February 2024, Polpharma Biologics (Polpharma) unveiled topline results demonstrating the pharmacokinetic (PK) and pharmacodynamic (PD) comparability of PB016, their biosimilar candidate for vedolizumab, with its reference drug, Entyvio, by Takeda Pharmaceutical.

Medical Globe V13K15

Comparing biosimilar adoption: Medicare Advantage versus traditional Medicare

Biosimilars/Research | Posted 03/04/2024

Biosimilar products, vital for widening access to essential treatments and reducing healthcare costs, face varied uptake influenced by factors like pricing and healthcare settings. Kozlowski et al.'s study compares adoption rates in Medicare Advantage (MA) and Traditional Medicare (TM), revealing significant differences [1].

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Questioning the need for ethnic sensitivity assessments for biosimilar monoclonal antibodies

Biosimilars/Research | Posted 27/03/2024

A GaBIJ perspective article entitled ‘Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not?’, was published by a group of authors from Biocon Biologics in August 2023 [1].

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ANVISA's role in biosimilar medicine regulation and innovation promotion

Biosimilars/Research | Posted 22/03/2024

The focus of the study by Vilha et al. [1] was to comprehend the role of the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (ANVISA), not only as a regulatory authority but also as a catalyst for technological development and innovation. ANVISA has implemented a significant change in the way health regulations are handled in Brazil.

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Infliximab discontinuation in patients with originator retransition vs biosimilar continuation

Biosimilars/Research | Posted 07/03/2024

A study by Meijboom et al. aimed to compare the risk of and reasons for infliximab discontinuation between retransitioned patients and those remaining on biosimilar [1].