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].

What does the designation of interchangeability for biosimilars in the US mean?

Biosimilars/Research | Posted 02/09/2022

Biologicals have significantly improved patients’ quality of life, yet, access to these critical medicines are constrained due to cost and this is being exacerbated by the misperceptions around biosimilars. In particular, imprecise terminology has been applied to biosimilars, leading to the implication that biologicals designated as interchangeable by the US Food and Drug Administration (FDA) are better biosimilars. The US is the only jurisdiction in the world with this additional designation from the regulator as an option for biosimilar sponsors to consider [1].

Access to biosimilars for cancer treatments in Latin America

Biosimilars/Research | Posted 26/08/2022

In many Latin America countries, patient access to biosimilars for cancer treatment remains restricted. In particular for patients with breast cancer and colorectal cancer, biosimilars can be a step further to increasing access to care [1].

Biosimilar regulations perspective in Latin America to improve cancer treatment access

Biosimilars/Research | Posted 22/07/2022

To address the issue of regulatory process of biosimilars, including intended copies*, the Americas Health Foundation (AHF) conducted a literature review and convened a panel with eight experts in biological cancer therapies and health economics to address the most salient issues concerning the regulation of biosimilars in Latin America [1].

Pegfilgrastim biosimilar Udenyca demonstrated similar immunogenicity to Neulasta

Biosimilars/Research | Posted 22/07/2022

The pegfilgrastim biosimilar Udenyca (pegfilgrastim-cbqv) is a pegylated, long-acting form of filgrastim (granulocyte colony-stimulating factor [G-CSF]). It is approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as a biosimilar of the originator pegfilgrastim (Neulasta) for febrile neutropenia in patients receiving myelosuppressive chemotherapy [1, 2].

Therapeutic drug monitoring with infliximab improves disease control

Biosimilars/Research | Posted 15/07/2022

The latest study from the Norwegian Drug Monitoring (NORDRUM) trial [1] shows that proactive therapeutic drug monitoring (TDM) for patients receiving maintenance infliximab therapy improves disease control, compared to treatment without TDM.

WHO revised guidelines for biosimilars: scientific background

Biosimilars/Research | Posted 08/07/2022

A study carried out by Kurki P et al. in 2022 reviewed the current clinical experience and scientific evidence to provide an expert perspective for updating the World Health Organization (WHO) guidelines on evaluation of similar biotherapeutic products (SBPs; also called biosimilars) to increase flexibility and clarity.

Positive phase III results for Samsung Bioepis’ Soliris biosimilar

Biosimilars/Research | Posted 08/07/2022

Samsung Bioepis announced that its biosimilar to Soliris (eculizumab) has comparable efficacy and safety and is bioequivalent to the originator. 

Adalimumab biosimilar MSB11022: PK and tolerability of autoinjector versus pre-filled syringe

Biosimilars/Research | Posted 01/07/2022

The antitumour necrosis factor-alpha (anti-TNF‑a) monoclonal antibody adalimumab is used to treat a variety of chronic immune-mediated inflammatory diseases, including rheumatoid arthritis, psoriasis, psoriatic arthritis, juvenile arthritis and inflammatory bowel disease. The biosimilar MSB11022 (Idacio/Kromeya) has demonstrated physicochemical and functional similarity to reference adalimumab (Humira) in the preclinical setting. Further study in the clinical setting has established equivalent pharmacokinetics (PK) and efficacy, and comparable safety and immunogenicity for MSB11022 versus adalimumab. MSB11022 is available in three delivery formats: pre-filled syringe, vial and autoinjector. Offering a choice of devices can address patient needs and potentially improve adherence to therapy. Self-injection via pre-filled syringes may be challenging for some patients, due to issues such as needle phobia, pain-related concerns and arthritis hand pain making self-injection more difficult. The availability of alternative self-injection devices allows patients to select a device that suits their needs.