{"id":49628,"date":"2022-10-14T04:01:54","date_gmt":"2022-10-14T02:01:54","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/prestige-biopharma-submitted-pre-bla-type-4-meeting-request-to-fda-for-herceptin-biosimilar\/"},"modified":"2022-10-14T04:01:54","modified_gmt":"2022-10-14T02:01:54","slug":"prestige-biopharma-submitted-pre-bla-type-4-meeting-request-to-fda-for-herceptin-biosimilar","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/prestige-biopharma-submitted-pre-bla-type-4-meeting-request-to-fda-for-herceptin-biosimilar\/","title":{"rendered":"Prestige Biopharma Submitted Pre-BLA Type 4 Meeting Request to FDA for Herceptin Biosimilar"},"content":{"rendered":"
\n

SINGAPORE–(BUSINESS WIRE)–#BLA<\/a>–Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, has submitted a request to the U.S. Food and Drug Administration (FDA) for a pre-submission meeting to discuss the company\u2019s planned Biologics License Application (BLA) for its Herceptin Biosimilar, HD201(Tuznue\u00ae<\/sup>).\n<\/p>\n

<\/a><\/p>\n

\nThe Biosimilar Biological Product Development (BPD) Type 4 Meeting is to discuss the format and content of a BLA in advance of the final submission. The company will discuss the overall development program of HD201 with the FDA to identify potential filing and review issues. The meeting is expected to take place around November, and the BLA submission by the end of the year.\n<\/p>\n

\nPrestige Biopharma\u2019s HD201 is a proposed biosimilar to Roche\u2019s Herceptin\u00ae<\/sup> (trastuzumab) to be prescribed for the treatment of human epidermal growth factor 2 (HER2) positive breast and metastatic gastric cancer. Trastuzumab targets HER2, which is overexpressed in some types of cancer cells and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.\n<\/p>\n

\nCurrently, a New Drug Submission (NDS) for HD201 is under review by Health Canada and a Marketing Authorisation Application (MAA) by the Korea Ministry of Food and Drug Safety. In addition to filing a new MAA to the European Medicines Agency (EMA), the company also plans to apply for authorisation in other advanced biosimilars markets such as UK, Australia, and Singapore.\n<\/p>\n

\nLisa Park, CEO of Prestige Biopharma, commented: \u201cThis Type 4 Meeting will be the final gate of BLA submission for HD201. In addition to the Bridging Study on biosimilarity of HD201 to US-Herceptin\u00ae<\/sup> and the Biosimilar Initial Advisory Meeting with FDA in 2019, we have been through a series of meetings with the FDA on each step of the development to prepare the launch of HD201 in US to help more patients in need. We will take this final step to thoroughly review and finalise the application for FDA\u2019s approval.\u201d\n<\/p>\n

Contacts<\/b> <\/p>\n

\nMedia Inquiries
\n
Global Communications, Prestige Biopharma
\n
www.prestigebiopharma.com<\/a>
Yujin Suh
\n
+65-6924-6535
\n
info@prestigebio.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

SINGAPORE–(BUSINESS WIRE)–#BLA–Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, has submitted a request to the U.S. Food and Drug Administration (FDA) for a pre-submission meeting to discuss the company\u2019s planned Biologics License Application (BLA) for its Herceptin Biosimilar, HD201(Tuznue\u00ae). The Biosimilar Biological Product Development (BPD) Type 4 Meeting is to discuss the format and content of … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-49628","6":"format-standard","7":"category-industry"},"yoast_head":"\nPrestige Biopharma Submitted Pre-BLA Type 4 Meeting Request to FDA for Herceptin Biosimilar - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/prestige-biopharma-submitted-pre-bla-type-4-meeting-request-to-fda-for-herceptin-biosimilar\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Prestige Biopharma Submitted Pre-BLA Type 4 Meeting Request to FDA for Herceptin Biosimilar - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"SINGAPORE–(BUSINESS WIRE)–#BLA–Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, has submitted a request to the U.S. Food and Drug Administration (FDA) for a pre-submission meeting to discuss the company\u2019s planned Biologics License Application (BLA) for its Herceptin Biosimilar, HD201(Tuznue\u00ae). 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