While biosimilar stakeholders’ eyes have been on the recent launch of new products and on policy proposals that stand to impact these therapies, several new proposed biosimilar agents are making their way into clinical trials.

Polpharma’s PB006

On Friday, Polpharma Biologics’ phase 3 clinical trial of its natalizumab biosimilar, PB006, referencing Tysabri, made its first appearance at ClinicalTrials.gov.

The multicenter, randomized, parallel arm, double-blind study will enroll approximately 260 patients with relapsing-remitting multiple sclerosis who will be randomized to receive 12 doses, every 4 weeks, of either PB006 or the reference natalizumab.

The primary outcome measure of the study is the cumulative number of new active lesions from baseline to week 24. Brain magnetic resonance imaging will be performed at study sites to assess the number of new lesions per patient.

Secondary outcomes include the cumulative number of new active lesions at week 48, a comparison of annualized relapse rates at weeks 24 and 48, the number of persistent lesions at weeks 24 and 48, and evaluations of safety and immunogenicity, among others.

The study is expected to be completed in August 2021.

Last month, Polpharma and Sandoz announced that they had entered into a global commercialization agreement for the biosimilar.

Alteogen’s ALT-L9

Republic of Korea-based drug maker Alteogen expects to start its phase 1 clinical trial of ALT-L9, a proposed aflibercept biosimilar referencing Eylea, this month. The study will enroll approximately 30 patients, aged 50 or older, who have neovascular age-related macular degeneration.

Patients will receive intravitreal injections of the biosimilar or the reference drug every 4 weeks, and the study’s primary outcome measure is the occurrence of adverse events over a timeframe of 8 weeks.

According to the most recent update to the ALT-L9-01 trial’s data, Alteogen expects to complete the study in December 2020.  

Earlier this year, the drug maker reported that it had been granted a process patent for its method of purifying the biosimilar; according to the company, the culture conditions of the cells that produce the proteins necessary for the biosimilar are improved through its new method, allowing for large-scale manufacturing. The company has also indicated that its product shows greater resilience to high temperatures and has a longer shelf life than the originator drug.

Prestige Biopharma’s HD204

Finally, Prestige Biopharma will undertake a phase 3 study of its proposed bevacizumab biosimilar, HD204, to demonstrate equivalence of the biosimilar and the EU-licensed reference product, Avastin, in terms of efficacy, safety, pharmacokinetics (PK), and immunogenicity.

The trial, SAMSON-2, which has an estimated study completion date of February 2021, will enroll approximately 500 patients with non–small cell lung cancer.

Patients in the double-blind, parallel group, multicenter equivalence trial will be assigned to receive either HD204 plus carboplatin and paclitaxel or the EU-licensed reference bevacizumab. The primary outcome measure is best objective response rate by week 24. Any partial response or complete response before week 24 will be marked as response.

Secondary outcome measures include progression-free survival, overall survival, duration of response, incidence of treatment-related adverse events, and immunogenicity.

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

Prestige has indicated that it will file regulatory applications for the biosimilar in the US and EU regulatory territories in 2020.



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