Bevacizumab biosimilar(Outlook Therapeutics)

Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 ISELIN, NJ, USA I April 08, 2025 I Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD. The FDA has determined that the BLA is a Class 2 review, which results in a six-month review period from the date of resubmission. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025. ONS-5010, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) in the United States for the treatment of wet AMD and is expected to receive 12 years of regulatory exclusivity. “Our team has worked diligently to advance our development and regulatory strategies for ONS-5010 to get to this point and we are proud of the continued progress we have been able to achieve,” commented Lawrence Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics. “This BLA acceptance and PDUFA date are significant milestones in our continued mission to offer clinicians and their patients the first and only on-label, ophthalmic bevacizumab to treat wet AMD. We are committed to bringing an ophthalmic bevacizumab to market in the United States and are continuing our activities for potential commercialization.” The ONS-5010 BLA resubmission was based on the efficacy and safety demonstrated in NORSE EIGHT, as well as additional chemistry, manufacturing and controls (CMC) information requested by the FDA. As previously announced, following Type A meetings with the FDA in Q4 CY2023 to address the ONS-5010 Complete Response Letter (CRL), the FDA informed Outlook Therapeutics that, in order to meet the FDA’s requirement for a second adequate and well-controlled clinical trial of ONS-5010, it could conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 12 week study of treatment naïve patients with a primary efficacy endpoint at 8 weeks (NORSE EIGHT). Outlook Therapeutics believes that the complete data set for NORSE EIGHT and the additional CMC information in the BLA resubmission, combined with the data from the other NORSE clinical trials, provides the required evidence to support approval of the ONS-5010 BLA in the United States. About ONS-5010 / LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) ONS-5010 / LYTENAVA™ is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In the United States, ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is investigational. Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina. About Outlook Therapeutics, Inc. Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, including wet AMD. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics is working to initiate its commercial launch of LYTENAVA™ (bevacizumab gamma) in the EU and the UK as a treatment for wet AMD, expected in the second quarter of calendar 2025. In the United States, ONS-5010/LYTENAVA™ is investigational, and a BLA has been resubmitted to the FDA. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD. SOURCE: Outlook Therapeutics

Plus, news about Kodiak Sciences, Outlook Therapeutics and Avacta: Boehringer Ingelheim reports Phase 3 schizophrenia fail: The drug, iclepertin, did not show any “statistically significant effects on cognition or function” compared to placebo after six months. Boehringer was testing the drug in three Phase 3 studies , but did not break down the results for each trial while discontinuing the long-term extension. Iclepertin is an oral glycine transporter 1 (GlyT1) inhibitor, and was previously called BI 425809. — Max Gelman GSK acquires organoid biotech in tiny buyout: GSK is taking out a German startup called CELLphenomics. Terms of the deal aren’t being disclosed, but a GSK spokesperson said it would pay “under” €50 million. CELLphenomics had previously partnered with Charles River Laboratories on its organoid tech in 2023. — Max Gelman Kodiak’s Phase 1b eye data boost stock: The biotech’s VEGFxIL-6 bispecific antibody candidate, KSI-101, achieved improvements in best corrected visual acuity of up to 18 letters in three patients with macular edema secondary to inflammation, according to a Wednesday presentation . The company’s shares $KOD were up almost 19% at market close. — Ayisha Sharma Outlook reports Phase 3 success for eye drug: The biotech said its candidate, ONS-5010, showed non-inferiority versus Roche’s Lucentis in best corrected visual acuity in patients with wet age-related macular degeneration at 12 weeks. The data represent a turnaround from November when the same trial missed its pre-specified non-inferiority endpoint at eight weeks. Outlook plans to resubmit its BLA for ONS-5010 in the first quarter. — Ayisha Sharma Avacta’s lead candidate shrinks salivary gland cancers: The London- and Philadelphia-based drugmaker said its AVA6000 produced “meaningful” tumor shrinkage in five out of 10 patients with FAP-positive disease enrolled in a Phase 1b test. Avacta’s share price $AVCT rallied around 5% Wednesday morning. — Ayisha Sharma