Tagged as: Trastuzumab

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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Briefing completed in trastuzumab IPR appeals

On October 15, 2019, Genentech filed reply briefs in support of its Federal Circuit appeals from the PTAB’s final written decisions of unpatentability of the challenged claims of U.S. Patent Nos. 7,846,441 and 7,892,549, which are directed to methods of treating HER2+ cancer with trastuzumab (Cases Nos. 19-1263, 19-1265, 19-1267…

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Trastuzumab Appeals Update

Last week, several briefs were filed in Federal Circuit appeals relating to trastuzumab biosimilars: Trastuzumab IPR Appeals On September 3, 2019, the USPTO submitted responsive appellate briefs in Federal Circuit appeals from IPR final written decisions regarding two patents related to methods of treating HER2+ cancer with trastuzumab (Cases Nos….

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Taiwan-based EirGenix and Sandoz Partner to Commercialize EirGenix’s Trastuzumab Biosimilar

Taiwan-based EirGenix, Inc. and Sandoz recently announced that they have entered into an agreement, giving Sandoz an exclusive license to commercialize EirGenix’s proposed biosimilar version of Roche’s Herceptin (trastuzumab), which is now in in Phase III clinical development for treatment of human epidermal growth factor receptor 2 positive (HER2+) breast…

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FDA Approves Samsung Bioepis’s Trastuzumab Biosimilar

Today, the FDA approved Samsung Bioepis’s Ontruzant (trastuzumab-dttb), a biosimilar to Genentech’s Herceptin (trastuzumab), for the treatment of patients with HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.  Samsung Bioepis’s product is the subject of ongoing BPCIA litigation, pending before the District of Delaware. This is the third biosimilar…

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Prestige Biopharma Partners with Cipla Ltd. for Trastuzumab Biosimilar

On December 14, 2018, Prestige Biopharma (“Prestige”) announced a partnership with Cipla Ltd. (“Cipla”) for Prestige’s HD201, a proposed trastuzumab biosimilar of Roche’s Herceptin®.  Prestige’s HD201 is in Phase-3 clinical development for the treatment of patients with HER2-overexpressing breast cancer. According to the press release, under the agreement, Cipla will…

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