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News & Updates

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2020.11


Prestige Biopharma and Teva Israel Announce License and Supply Agreement to Commercialize Prestige's Trastuzumab Biosimilar (Tuznue™) in Israel

November 10, 2020 Prestige BioPharma Ltd. and Abic Marketing Ltd. (operates under the brand of Teva Israel, hereinafter "Teva Israel"), a subsidiary of Teva Pharmaceutical Industries Ltd. announced today that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige BioPharma's Trastuzumab biosimilar (HD201; Tuznue™) in Israel.
2020.09


Prestige BioPharma Presents Positive Top-Line Results from Phase III and New Data from 3-Arm Phase I Bridging Study for HD201 (Trastuzumab Biosimilar)

September 23, 2020 Prestige BioPharma announced positive top-line results from a Phase III global clinical trial have been presented in an oral presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 on September 18, 2020.

These top-line results, which confirm no clinically significant differences between HD201 and the originator product Herceptin®, demonstrate HD201’s exceptional similarity to Herceptin® in terms of clinical response and pharmacokinetics (PK), in addition to a comparable safety profile to the range previously observed in other trastuzumab biosimilar clinical trials.

Prestige BioPharma also reported that new data from the 3-Arm Phase I Bridging Study have been selected for a poster presentation during the virtual congress on September 17, 2020. The data includes results from a total of 105 healthy male subjects in the 3 arms, in which HD201 demonstrates equivalent PK to both EU-Herceptin® and US-Herceptin®.
2020.06


US FDA Grants Orphan Drug Designation (ODD) for Prestige BioPharma’s PBP1510 Anti-PAUF Monoclonal Antibody for the Treatment of Pancreatic Cancer

June 30, 2020 Prestige BioPharma Ltd. (hereinafter “Prestige BioPharma”) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its first-in-class anti-PAUF monoclonal antibody, PBP1510, for the treatment of pancreatic cancer.
2019.11



Prestige Biopharma at CPhI Worldwide 2019 in Frankfurt, Germany


November 7, 2019 This year's CPhI Worldwide has just concluded and we met with fellow pharmaceutical industry movers and stakeholders. Thank you for visiting Prestige at CPhI Worldwide.
2019.08

Prestige Biopharma partners with Huons to market three key biosimilars in South Korea


August 28, 2019 Prestige BioPharma announced that Prestige and Huons have entered into an exclusive partnership for the commercialization of three key biosimilars in South Korea.
2019.07

Prestige Biopharma partners with Mundipharma to market HD201, a trastuzumab biosimilar, in selected European countries


July 02, 2019 Prestige BioPharma announced that it has reached a licensing agreement with Mundipharma for its trastuzumab biosimilar (HD201) under which Mundipharma will have exclusive rights to distribute and market the drug in selected European markets.
2019.06

EU Investigator's Meetings for HD204 Bevacizumab Biosimilar Phase III (SAMSON-II ) in Turkey and Austria


June 26 & 28, 2019 EU Investigator's Meetings for HD204 Bevacizumab Biosimilar Phase III (SAMSON-II ) at Istanbul (Turkey) and Vienna (Austria) were completed successfully! APAC Investigator's Meeting is upcoming.
2019.06


Prestige BioPharma Reports Positive Top-Line Phase III Results for Tuznue®

June 24, 2019 Prestige BioPharma (herein, Prestige) announced positive top-line results from a Phase III global clinical trial (Troika) evaluating the efficacy, safety, and pharmacokinetics (PK) of biosimilar candidate HD201 to Herceptin (trastuzumab).
2019.05


European Medicines Agency Accepts Marketing Authorisation Application for Prestige BioPharma’s Trastuzumab Biosimilar HD201 for Review

May 28, 2019 Prestige BioPharma (herein, Prestige) announced that European Medicines Agency (EMA) has validated and accepted for review the Marketing Authorization Application (MAA) for its trastuzumab biosimilar HD201 (Tuznue®) on 23 May 2019.
2019.05
Successful EMEA Filing Submission for HD201, Herceptin Biosimilar
2019.03
Korea FDA GMP Certificate awarded to Prestige Bio Pharmaceuticals (PBK), Prestige's dedicated manufacturing facility
2019.03

2019 Bio Korea : Price Competitiveness is Important in the Biosimilar Market.


Michael Kim, Senior Director at Prestige, presented his key insights into winning the biosimilar market. Read it here
2018.12

Prestige Biopharma partners with Cipla Ltd to market key cancer biosimilar


Dec 14, 2018 Prestige BioPharma announced that it has reached a licensing agreement with Cipla Limited for its trastuzumab biosimilar (HD201) under which Cipla will have exclusive rights to distribute and market the drug in selected emerging markets.
2018.09

Grand Opening of Prestige Bio Pharmaceuticals Korea Osong Campus I


Sep 13, 2018 PrestigeBio Pharmaceuticals celebrated the successful completion of GMP facility, Osong Campus I, at their grand opening held September 11 in Osong, South Korea.
2018.07

Prestige BioPharma Singapore Initiates Listings in Korea Exchange with Samsung Securities


Jul 11, 2018 Prestige BioPharma and Samsung Securities, Korea (016360) have entered into a sponsorship and underwriting agreement for listing in Korea Exchange.
2018.06

Prestige BioPharma and Alvogen Announce License and Supply Agreement


Jun 28, 2018 Prestige BioPharma and Alvogen announce License and Supply Agreement: Two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige BioPharma’s Trastuzumab biosimilar (HD201; Hervelous) in Central and Eastern Europe.
2018.02

Prestige Bio Pharma Introduces Smart Factories Platform in Korea


Feb 21, 2018 Prestige Bio Pharmaceuticals, part of the PrestigeBio Group introduces state-of-the-art process system in collaboration with Thermofisher Scientific in Korea – ‘Smart Factory Platform’.

Where You Can Find Prestige!

Nov 5-7, 2019

Event: CPhI Worldwide
Venue: Frankfurt, Germany

Booth: 120C10
Sep 27- Oct 1, 2019

ESMO 2019
Venue: Barcelona, Spain

Booth: 316
May 31- Jun 4, 2019

Event: ASCO 2019
Venue: McCormick Place, Chicago, IL, USA

Booth: 5151
Apr 30- May 2, 2019

Event: CPhI North America
Venue: McCormick Place, Chicago, IL, USA

Booth: 1647
Apr 17 - Apr 19, 2019

Event: BioKorea 2019
Venue: COEX, Seoul, Korea
Oct 9-11, 2018

Event: BioLive Europe
Venue: IFEMA, Madrid

Booth: #12A22
Jan 8- 11, 2018

Event: J.P. Morgan Healthcare Conference
Venue: San Francisco, CA
Nov 6-8, 2017

Event: Bio-Europe
Venue: Berlin, Germany
Jun 6 - 9, 2016

Event: Bio International
Venue: San Francisco, CA
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