One of the companies wanting to be part of the upcoming U.S. launch of Humira biosimilars is instead exploring options to raise additional capital so it can continue advancing its biosimilar pipeline in the near term. Alvotech Holdings SA, a pure-play biosimilars company based in Iceland, initially had hoped for FDA approval June 28 for AVT-02, developed as both an interchangeable and biosimilar to the high-concentration formulation (HCF) of Abbvie Inc.’s blockbuster autoimmune drug, Humira (adalimumab).
Sometimes a merger or acquisition brings a device that has a set of indications for use that cannot be practicably expanded, but Nathan Downing of Gardner Law of Stillwater, Minn., said this is not always the case. Downing said that preliminary conversations between the two parties to mergers and acquisitions can clarify a lot about whether a particular device has ample room to grow.
The FDA has awarded orphan drug designation to HL-001, a novel lysophosphatidic acid receptor-1 (LPA1) antagonist being developed for idiopathic pulmonary fibrosis (IPF) by Ube Corp. and Hilung Inc.
Makers of dental equipment don’t typically show up on the U.S. FDA enforcement radar screen, but the introduction of biologics and software into routine dental practice has upped the regulatory stakes. This can be seen in the June 20, 2023, warning to Vitang Technology LLC, of Tustin, Calif., which cited the company for failure to validate a change of software used in orthodontic treatment planning systems, but the FDA reinforced the notion that claiming that the agency approved or cleared the device is also a violation of the Code of Federal Regulations.
Despite imperfect data and the use of post hoc analyses to overcome a failed endpoint, the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 10-4 June 28 that Ipsen SA’s ultra-rare bone disease drug, palovarotene, demonstrated efficacy in treating patients with fibrodysplasia ossificans progressiva (FOP).
Opko Health Inc. stands to receive a $90 million milestone payment from partner Pfizer Inc. on the U.S. FDA approval of once-weekly human growth hormone analogue Ngenla (somatrogon) for pediatric patients with growth hormone deficiency. Pfizer expects to make the drug available to patients starting in August 2023.
With the biggest biosimilar launch in the U.S. just days away, Humira’s (adalimumab) record-breaking ride is quickly slowing down, but the Abbvie Inc. mega-blockbuster immunology drug is nowhere near the end of its road. Meanwhile, the U.S. journey is just beginning for the eight adalimumab biosimilars that could come to market as early as July 1 through licensing agreements with Abbvie. Besides revving their engines against Humira, the new launches will be looking to overtake Amgen Inc.’s biosimilar, Amjevita, which got a five-month headstart in the U.S., thanks to the first-mover status Amgen earned for being the first to sign a licensing agreement with Abbvie.
After nearly 10 years in clinical development and just a few months after an EMA rejection, Ipsen SA will be making its case June 28 before a U.S. FDA advisory committee for its ultra-rare bone disease drug, palovarotene.
Adults with generalized myasthenia gravis (gMG) have yet another therapeutic option, this time from UCB SA, with the U.S. FDA’s approval of orphan drug Rystiggo (rozanolixizumab-noli), a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor.
Benitec Biopharma Inc. has received FDA clearance of its IND application for BB-301, its silence and replace gene therapy for the treatment of oculopharyngeal muscular dystrophy (OPMD)-related dysphagia.
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