Tagged as: Trastuzumab

Celltrion’s Trastuzumab Biosimilar Earns WHO Prequalification Status

Celltrion recently announced that its trastuzumab biosimilar, Herzuma, has met the World Health Organization’s (WHO) prequalification standards.  WHO prequalification status is based on an assessment of the quality, safety, and efficacy of a medicine and enables the recipient to participate in UN procurement tenders.  Herzuma has been commercially available in Europe since May 2018,…

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Henlius and Accord Announce EMA Recommendation for Marketing of Their Trastuzumab Biosimilar

We previously reported on Shanghai Henlius’s (“Henlius”) biosimilar developments, including their announcement of an exclusive license agreement with Mabxience Research, S.L. to develop and commercialize their trastuzumab biosimilar, HLX02. This week, Henlius jointly announced with Accord Healthcare Limited that the Committee for Medicinal Products for Human Use (CHMP) of the…

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AryoGen’s bevacizumab biosimilar BE1040V found noninferior to AVASTIN in phase III study

In a study published in Clinical Therapeutics on April 22, AryoGen Pharmed’s proposed bevacizumab biosimilar, BE1040V (STIVANT), was found to be noninferior to the reference product (AVASTIN) in a Phase III clinical trial in patients with metastatic colorectal cancer.  AryoGen Pharmed is a pharmaceutical manufacturer based in Iran that specializes…

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Samsung Bioepis and Merck Announce U.S. Launch of Trastuzumab Biosimilar

On Wednesday, Samsung Bioepis and Merck announced the U.S. launch of Ontruzant® (trastuzumab-dttb), a biosimilar to Herceptin® (trastuzumab).  Ontruzant® is indicated for the treatment of HER2-overexpressing breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, and is available in both 150 mg single-dose vials and 420 mg multiple-dose vials. …

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District Court of Delaware Construes “Following Fermentation” in Genentech v. Amgen Trastuzumab and Bevacizumab Cases

We have previously reported on the BPCIA Genentech v. Amgen cases relating to trastuzumab and bevacizumab. This week, Judge Connolly construed the term “following fermentation” as it relates to U.S. Patent No. 8,574,869 (“the Kao patent”) to mean “after the earlier of harvesting or purification has begun.” By way of…

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Merck Transfers Biosimilars and Other Products to Spinoff Company

Last week, Merck announced its intention to spin-off products from its Women’s Health, legacy brands, and biosimilars businesses into a new, yet-to-be-named, independent, publicly traded company.  According to Merck, “NewCo will pursue global leadership and focused, sustainable growth in Women’s Health led by the growing and patent-protected NEXPLANON (etonogestrel implant)…

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Biosimilar and Biologic Business Developments Update – Collaborations and Licensing Deals

Last week, Almirall signed an agreement with WuXi Biologics to collaborate on multiple bispecific antibodies targeting dermatology conditions, including atopic dermatitis. Almirall’s press release indicated that, “[u]nder the terms of the agreement, Almirall has access to WuXi Biologics’ proprietary antibody platforms including WuXiBody™ to discover multiple novel bispecific antibodies.” This…

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World Health Organization (“WHO”) Prequalifies Biosimilar Trastuzumab – WHO’s First Biosimilar

Today, the World Health Organization (“WHO”) prequalified Samsung Bioepis’s breast cancer biosimilar trastuzumab – WHO’s first biosimilar prequalification.  Prequalification is “a service provided by WHO to assess the quality, safety and efficacy of those products that address global public health priorities.”  The WHO noted that the global average price of…

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Clinical Trial Announcements

This week, several companies reported updates in their clinical development of biosimilars or follow-on biologics. On December 3, Outlook Therapeutics (formerly known as Oncobiologics) announced the FDA agreed with three of Outlook’s proposed Special Protocol Assessments (“SPAs”) relating to ONS-5010, an investigational ophthalmic formulation of bevacizumab which is currently in…

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U.S. Biosimilar Launches: Mylan/Biocon’s Trastuzumab, Sandoz’s Pegfilgrastim

Yesterday, Mylan N.V. and Biocon Ltd. announced the U.S. launch of OGIVRI (trastuzumab-dkst), a biosimilar to HERCEPTIN (trastuzumab).  According to the press release, “OGIVRI™ is approved for all indications of HERCEPTIN® including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma),” and is available in both…

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