Phase III trials started for bevacizumab and natalizumab biosimilars

Biosimilars/News | Posted 06/12/2019 post-comment0 Post your comment

Phase III trials have started for proposed biosimilars of bevacizumab and natalizumab.

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Singapore-based Prestige BioPharma (Prestige) has, according to, started a phase III trial for its candidate bevacizumab biosimilar, HD204.

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

The SAMSON-2 study will compare HD204 to its reference product EU-licensed Avastin. The trial is a randomized, double-blind, parallel group, equivalence, multicentre, phase III study in 500 patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). The aim of the study is to demonstrate equivalence of HD204 and EU-licensed Avastin in terms of efficacy, safety, pharmacokinetics and immunogenicity. The study is expected to be completed in February 2021.

This study follows on from the phase I study, SAMSON-1, which Prestige announced in July 2019 had met its primary end point of area under the concentration curve from time zero to infinity. The phase I study also established pairwise pharmacokinetic similarity among HD204, US-licensed Avastin and EU-licensed Avastin.

Prestige says that it will file for approval for HD204 in the US and Europe in 2020.

Poland-based Polpharma Biologics (Polpharma) has, according to, started a phase III trial for its candidate natalizumab biosimilar, PB006.

Natalizumab is a human monoclonal antibody against the cell adhesion molecule α4-integrin. Natalizumab is believed to work by reducing the ability of inflammatory immune cells to attach to and pass through the cell layers lining the intestines and blood–brain barrier. Natalizumab is indicated for the treatment of multiple sclerosis (US and Europe) and Crohn’s disease (US).

The phase III trial is a multicentre, randomized, parallel arm, double-blind study with a total duration of 48 weeks. Approximately 260 participants with relapsing-remitting multiple sclerosis (RRMS) will be randomized to receive 12 doses of either PB006 or EU-licensed natalizumab (Tysabri).

The aim of the study is to compare the efficacy and safety of PB006 versus Tysabri in patients with RRMS. The study is expected to be completed in August 2021.

In September 2019, Polpharma signed a worldwide agreement giving Sandoz, the generics division of Novartis, commercialization rights to Polpharma’s candidate natalizumab biosimilar (PB006) [1].

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1. GaBI Online - Generics and Biosimilars Initiative. Sandoz makes deal with Polpharma for natalizumab biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from:

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