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…
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…
We previously reported on the bevacizumab preliminary injunction appeal in Genentech v. Immunex Rhode Island Corp., Fed. Cir. Case No. 19-2155. The notice of oral argument was posted today and is scheduled for June 3, 2020.
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…
Last week, Mylan announced on its quarterly earnings call that the U.S. FDA has accepted the company’s aBLA for a biosimilar of AVASTIN (bevacizumab), which is now under review with a user fee goal date of December 27, 2020. Mylan is the fourth biosimilar developer to report the filing of…
On February 11, 2020, in the Genentech v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss Amgen’s affirmative defenses and counterclaims. Amgen had pled counterclaims seeking declaratory judgments that the asserted patents are…
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…
Below we provide an update on some recent developments from this and recent weeks in biosimilar-related cases on appeal before the Federal Circuit. Genentech v. Hospira & U.S., Fed. Cir. Case No. 18-1933 – protein purification method IPR appeal Today, the Federal Circuit issued a 2-1 opinion affirming a 2018…
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…
Dr. Reddy’s Laboratories, Ltd. announced the launch of VERSAVO (bevacizumab), a biosimilar of Roche’s AVASTIN, in India today. VERSAVO is indicated for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, cervical cancer, metastatic breast cancer and epithelial ovarian, fallopian tube and…