Trastuzumab Biosimilar (Prestige BioPharma)

The FDA has numerous activities and interactions with Phanes, Prestige Biopharma, Reata, Pfizer and more, providing clearance, approving clinical trials and other regulatory actions. Here’s a look at what kept the agency busy this week. Oct. 14 Phanes Therapeutics was cleared to initiate a Phase I trial of PT217, an anti-Delta-like ligand 3 (DLL3)/anti-Cluster of differentiation 47 (CD47) bispecific antibody for small cell lung cancer and other neuroendocrine cancers. Prestige Biopharma submitted a request to the FDA for a pre-submission meeting to discuss its expected BLA application for a Herceptin biosimilar, HD201(Tuznue). Oct. 13 Reata Pharmaceuticals announced the FDA informed the company it will not hold an advisory committee meeting related to its New Drug Application (NDA) for omaveloxolone for treatment of Friedreich’s ataxia. Oct. 12 Eagle Pharmaceuticals submitted an Investigational New Drug (IND) application for a Phase II trial of CAL-02 for treatment of severe community-acquired bacterial pneumonia. Galactin Therapeutics received the go-ahead for a Phase II trial of belapectin with Merck’s Keytruda (pembrolizumab) for first-line treatment of recurrent/metastatic PD-L1 positive squamous cell carcinoma of the head and neck. Regeneron Pharmaceuticals reported the FDA accepted for Priority Review its supplemental Biologics License Application (sBLA) for Eylea (aflibercept) injection to treat Retinopathy of Prematurity (ROP) in preterm infants. Pfizer and BioNTech received Emergency Use Authorization (EUA) for a 10-microgram dose of their Omicron BA.4/BA.5 bivalent COVID-19 vaccine for kids 5 through 11 years of age. SiSaf initiated the FDA regulatory process to obtain Orphan Drug Designation for SIS-101-ADO, a siRNA therapeutic for Autosomal Dominant Osteopetrosis Type 2 (ADO2). BridgeBio Pharma announced the FDA granted Fast Track designation for BBP-398 in combination with Amgen’s Lumakras (sotorasib) for adults with previously treated KRAS G12C-mutated, metastatic non-small cell lung cancer. Oct. 11 Eligo Bioscience’s EB003 received Orphan Drug Designation and Rare Pediatric Disease designation for EB003 to treat Shiga-toxin producing bacterial infection as it relates to the prevention of hemolytic uremic syndrome. Incannex Healthcare reported it completed a constructive pre-IND meeting with the FDA for its IHL-216A for treatment of traumatic brain injury and concussion. Aquestive Therapeutics received positive written feedback from the FDA for its initial End-of-Phase II meeting request to discuss Chemistry, Manufacturing and Controls (CMC) for its AQST-109 epinephrine sublingual film for the treatment of severe allergic reactions, including anaphylaxis. XACT Robotics’ ACE Xtend Remote Control Unit was granted FDA clearance, allowing users to robotically insert and steer the XACT ACE Robotic System remotely from a control room. Biomind Labs announced the FDA granted a Pre-IND meeting for its Triptax, a new chemical entity that could be used as an active pharmaceutical ingredient or chemical precursor to treat depression. Gilead Sciences reported the FDA accepted an sBLA for Trodelvy (sacituzumab govitecan-hziy) for priority review for the treatment of adults with unresectable locally advanced or metastatic HR+/HER- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. TeraImmune received the go-ahead to initiate a Phase I/IIa trial of TI-168 in congenital Hemophilia A patients with refractory inhibitors. TI-168 is a next-generation, autologous FVIII TCR-Treg cell therapy. Oct. 10 scPharmaceuticals’ Furoscix (furosemide injection) was approved for the treatment of congestion due to fluid overload in adults with New York Heart Association Class II/III chronic heart failure. The FDA issued its briefing documents arguing for the market withdrawal of Covis Pharma’s Makena, which was approved to reduce the risk of preterm birth in women with a singleton pregnancy with a history of spontaneous preterm birth. IRadimed Corporation voluntarily withdrew its 510(k) application for its next-generation MR IV pump due to the need to supply additional information within a timeline the company could not manage. Nanoscope Therapeutics received Fast Track Designation for MCO-0101, an ambient-light activatable Multi-Characteristic Opsinoptogenetic monotherapy to restore vision in blind patients for the treatment of retinitis pigmentosa by way of intravitreal injection. Oct. 7 GlaxoSmithKline’s Boostrix, a vaccine against whooping cough, was approved by the FDA for infants under the age of two months.

Biosimilar development continues to advance for the U.S. market in anticipation of becoming an alternative to a brand drug with similar safety and efficacy. Earlier this month, Kashiv BioSciences won FDA approval for Releuko, a biosimilar to Amgen’s Neupogen. Releuko, which was co-developed with Amneal Pharmaceuticals, is expected to launch in the third quarter of 2022 as a treatment for neutropenia, a low white blood cell condition experienced by chemotherapy patients. Two other biosimilars for Neupogen have been approved, including Zarxio and Nivestym. Chandramauli Rawal, chief operating officer for Kashiv, said the company is one of the few U.S. –based companies to manufacture and launch a biosimilar for the U.S. market. Beyond the Neupogen biosimilar, Rawal said Kashiv is also developing a biosimilar to Amgen’s Neulasta. It aims for approval of its Biologics License Application later this year. Additionally, Kashiv and Amneal hope to secure approval for a biosimilar to Genentech’s Avastin. Chirag and Chintu Patel, co-chief executive officers for Amneal, noted that biosimilars represent the “next wave of providing access to affordable medicines in the U.S.” They said Amneal intends to become a long-term player in the biosimilar market. Biosimilars are biologic products that are highly similar to a branded drug but are always uniquely different in composition. Biosimilar treatments can be attractive to treating physicians because of the understanding that the products are so similar to the original reference drug. That makes them equally as effective and available at a significant cost reduction. Since Zarxio was first approved in 2015 by the FDA, there have been 33 other biosimilars that have received the green light in the U.S. Not all of them are yet on the market due to existing patents that protect against the competition, such as the case with AbbVie’s Humira. Patent protection for that drug, which generated about $20 billion in revenue in 2021, fall next year, paving the way for multiple biosimilars. Multiple companies have been making headway with biosimilars in the U.S., even as some have fought tooth and nail to prevent competition for their branded drugs. Biosimilar treatments have a stronger platform in Europe, which has been in use for years. However, in the U.S., traction has been somewhat difficult due to some systemic issues with insurance programs, including formulary design and overcoming some misinformation regarding safety and efficacy, a recent report showed. The report, Improving Drug Management: Employer Strategies on Biosimilars, was authored by the National Alliance of Healthcare Purchaser Coalitions. “The U.S. lags Europe in embracing and expanding the biosimilars market,” Michael Thompson, National Alliance president and CEO, said in a statement. “Educating plan sponsors about barriers to broader adoption of biosimilars will enable them to challenge the market dynamics blocking this critical channel to achieve a more competitive drug market.” Prestige BioPharma, a Singapore-based company, hopes to break through those market barriers with its Herceptin biosimilar. This morning, the company announced positive Phase III results that show HD201 has a comparative safety and efficacy to the Genentech cancer drug. Data was published in the Journal of the American Medical Association Oncology. If approved, HD201 will be marketed under the brand name Tuznue. Prestige said the difference between the Herceptin treatment group and the HD201 group was not significant and fell within the predefined equivalence margins. Similar safety, P.K. and immunogenicity results were reported for the two treatment arms. Some analyses are ongoing, including three-year event-free survival, as well as overall survival. The preliminary results of the current final analysis indicate highly comparable rates in both areas for HD201 and Herceptin. In addition to the Herceptin biosimilar, Prestige is also developing an Avastin biosimilar and a Humira biosimilar.