Tagged as: Bevacizumab

Genentech, Inc. and JHL Biotech, Inc. File a Stipulation for Entry of a Proposed Consent Judgment and Permanent Injunction; Court Order in Response Asks Parties to Answer Questions

On September 9, 2020, Genentech, Inc. and JHL Biotech, Inc. filed a stipulation for entry of a proposed consent judgment and permanent injunction as to JHL Biotech, Inc.  That proposed consent judgment and permanent injunction is the result of the parties’ June 18, 2020 settlement agreement, in which JHL represented…

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Cadila Pharmaceuticals Announces Launch of Fourth Biosimilar in Two Months

Today, Cadila Pharmaceuticals announced the launch of its adalimumab biosimilar, Cadalimab™, in India. HUMIRA® (adalimumab) is approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis. Cadila’s press release noted that “[i]n an effort to strengthen their biosimilar product portfolio, Cadalimab™ is the fourth biosimilar launched in the last…

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Centus Biotherapeutics Receives Positive Opinion for EQUIDACENT (Bevacizumab Biosimilar) in Europe

On July 23, 2020, Centus Biotherapeutics received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for EQUIDACENT, a biosimilar to AVASTIN (bevacizumab), intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer,…

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International Biosimilars Market Update

Yesterday, India-based Cadila Pharmaceuticals announced the launch of its bevacizumab biosimilar for the Indian market under the brand name BEVARO. Bevacizumab is a biosimilar of Genentech’s AVASTIN and is indicated for the treatment of multiple cancers, including ovarian cancer, glioblastoma multiforme, colorectal cancer, breast cancer, lung cancer, cervical cancer, and…

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Bevacizumab Updates

On June 16, 2020, Shanghai Henlius Biotech, Inc. announced that HLX04-mCRC03, a phase 3 clinical trial of bevacizumab biosimilar HLX04, had successfully met its primary endpoint.  The study compared the safety, efficacy and immunogenicity of HLX04 and Avastin in combination with oxaliplatin and fluoropyrimidine-based chemotherapy as first-line treatment in patients…

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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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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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