Below we provide an update on several ophthalmic anti-VEGF therapeutics currently being studied in clinical trials. EYLEA® HD (Aflibercept, 8 mg) Regeneron announced positive two-year (96 weeks) results from its PULSAR trial investigating Eylea® HD (aflibercept, 8 mg) with 12- and 16-week dosing regimens compared to EYLEA® (aflibercept, 2 mg)…
The ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics will be held on June 28 – 29, to contemplate the details of the rapidly changing landscape for biosimilars and innovator biologics. Goodwin is a proud sponsor of the conference and, Goodwin partner and Big Molecule Watch editor, Huiya Wu is a…
On December 24th, 2021, Innovent Biologics announced that China’s National Medical Products Administration had accepted its Supplemental New Drug Application (sNDA) for TYVYT®, a sintilimab plus bevacizumab biosimilar injection and chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung-cancer (nsqNSCLC) who progressed after EGFR-TKI therapy. The sNDA is based on…
Innovent Biologics, Inc. announced that the National Medical Products Administration of China (“NMPA”) approved its supplemental New Drug Application for TYVYT®, a sintilimab injection, in combination with BYVASDA®, a bevacizumab biosimilar injection, as a first-line treatment for people with advanced or unresectable hepatocellular carcinoma (“HCC”). According to the press release,…
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…