- Following approval by the European Commission, Prestige
Biopharma's Herceptin biosimilar Tuznue® would become the first
biosimilar from a Singaporean company to be authorized in the
European Union.
SINGAPORE, Aug. 1, 2024 /PRNewswire/ -- Prestige Biopharma,
a pioneer in biopharmaceuticals, announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has recommended marketing authorization for Tuznue®, a
Herceptin (trastuzumab) biosimilar. This milestone positions
Prestige Biopharma to become the first Singaporean firm to
commercialize its biosimilar in the European Union.
The CHMP's positive opinion is based on clinical evidence
from Phase 1 and Phase 3 clinical studies that tested the
biosimilarity of Tuznue® to Herceptin®. The
Phase 1 clinical PK study in healthy volunteers demonstrated PK
equivalence, as well as similarity in safety and immunogenicity.
Finally, the global Phase 3 confirmatory efficacy and similarity
study met its primary endpoint and demonstrated similarity in
efficacy, PK, safety, and immunogenicity in HER2-positive patients
with early breast cancer. This favourable decision is a crucial
step toward final approval from the European Commission (EC). Once
approved, Tuznue® will be commercialized across
Europe.
Prestige Biopharma has already established licensing agreements
with major pharmaceutical partners for global marketing and sales.
These agreements are set to generate immediate milestone payments
and provide early revenue for the company. Negotiations are also
underway to ensure a strong market entry for Tuznue® in
Europe.
"Receiving a positive CHMP opinion for
Tuznue® marks a major milestone for Prestige
Biopharma, significantly advancing our revenue generation strategy
and accelerating future pipeline approvals," said Lisa Park, the CEO of Prestige Biopharma. "This
recognition solidifies our position as a leading biosimilar
developer. We are committed to leveraging this achievement to
enhance our market presence and drive continued success."
About TUZNUE® (HD201, Herceptin biosimilar)
Tuznue® is a biosimilar of Herceptin® (trastuzumab), developed
to offer a more cost-effective therapeutic alternative for
patients. It maintains comparable efficacy and safety profiles to
the original branded medication. Tuznue® is indicated for the
treatment of patients with HER2-positive metastatic breast cancer
(MBC), HER2-positive early breast cancer (EBC), and HER2-positive
metastatic gastric cancer (MGC).
About Prestige Biopharma:
Established in 2015 in Singapore and listed in the Korea Exchange in
2021 (KOSPI: 950210), Prestige Biopharma Limited is a
biopharmaceutical company with a diversified portfolio, including
biosimilars (HD204 Avastin biosimilar in filing stage, PBP1502
Humira biosimilar in clinical stage) and new antibody drugs. Among
its many pipelines, a first-in-class antibody drug and key
biosimilars referencing blockbuster drugs are ongoing clinical
development. Notably, the first-in-class, PAUF-based antibody drug,
Ulenistamab, has been granted Orphan Drug Designation by the U.S.
Food and Drug Administration (FDA), the European Medicines Agency
(EMA), and the Ministry of Food and Drug Safety (MFDS) in Korea, as
well as Fast Track Designation by the U.S. FDA. A global Phase 1/2a
clinical trial is currently underway in the United States, Europe, and Asia, with the aim of bringing this innovative
therapy to the clinic.
Contacts
Prestige Biopharma Group
Donghee Im
donghee.im@prestigebio.com
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