Regulations

Second CRL leaves Alvotech with potential Humira biosimilar delay

US approval of Alvotech’s Humira (adalimumab) biosimilar could be delayed by six months after the FDA found further issues at a manufacturing facility in Reykjavik, Iceland. Thanks to a 2017 settlement with AbbVie, Amgen launched the first biosimilar of best-selling monoclonal antibody Humira earlier this year. At the end of next month, up to nine more biosimilars could be competing for a slice of the $18.6 billion market. Iceland-based firm Alvotech has two separate applications for AVT02, with the first Biologics…

Krystal clear: FDA approves redosable gene therapy gel Vyjuvek

Krystal Biotech has won approval for Vyjuvek (beremagene geperpavec), a topical gel gene therapy to treat the skin condition dystrophic epidermolysis bullosa (DEB). The handful of gene therapies on the market are single-dose injections or infusions, but the US Food and Drug Administration (FDA) approved the first ‘redosable’ gene therapy Friday, in the form of Krystal’s Vyjuvek. Vyjuvek is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, which when administered topically to DEB wounds delivers two copies of the…

Two-pronged approach advances Omisirge accessibility, says Gamida

Gamida Cell says its two-pronged strategic approach includes accomplishing a successful commercial strategy with FDA approved Omisirge and pursuing partnerships. In April, the US Food and Drug Administration (FDA) approved Gamida’s Omisirge (omidubicel), an allogeneic cell therapy for patients with blood cancers who are set to undergo stem cell transplantation. Omisirge is a modified allogeneic cord blood-based cell therapy to quicken the recovery of neutrophils and reduce the risk of infection. It is intended for use in patients with blood…

Lilly working to resolve mirikizumab manufacturing issues following CRL

Eli Lilly expects mirikizumab to become the first interleukin-23 subunit alpha (IL-23p19) to treat ulcerative colitis once manufacturing issues highlighted by the US FDA are resolved. Last month, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Eli Lilly for mirikizumab, its monoclonal antibody candidate for the treatment of ulcerative colitis (UC). Patrik Jonsson, president of Lilly Immunology, discussed his company’s approach to resolving the issue at the Bank of America Securities 2023 Healthcare Conference…

Trial regs a challenge for vaccine developers, study

Running vaccine trials in developing countries is a significant challenge due to complex regulations and CRO management difficulties according to new analysis. The study – published in the current edition of the journal Vaccine X – looked at approaches to clinical development vaccine developers in emerging countries are using. The overall aim is to identify industry needs in terms of organizational development and training. The authors quizzed members of the Developing Countries Vaccine Manufacturers Network (DCVMN) – a voluntary alliance…

GSK ready to meet RSV vaccine demand after Arexvy approval

Arexvy has become the first FDA approved vaccine to treat respiratory syncytial virus (RSV) and will be produced across GlaxoSmithKline’s European and US manufacturing network. The US Food and Drug Administration (FDA) approved Arexvy last week, for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV). “Arexvy contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant,” a spokesperson told BioProcess Insider. “Arexvy will have two vials (one antigen…

FDA hits both Lilly and Rentschler with 483s

Aseptic manufacturing concerns have landed Eli Lilly and Rentschler separate Form 483s at facilities that have previously fallen foul of the US FDA. The US Food and Drug Administration (FDA) inspection of the 1555 South Harding Street, Indiana, Indianapolis facility in October 2022 resulted in Eli Lilly receiving a Form 483 with three observations. The document cites Lilly’s aseptic technique for drug product filling operation as “deficient,” with concerns surrounding unprotected sterile surfaces and the actions of operators at the…

European CGT sector falling behind US and Asia

Europe’s cell and gene therapy sector has stagnated but advocacy group the Alliance for Regenerative Medicine (ARM) hopes upcoming legislation can reinvigorate the sector. In many areas of pharma, Europe has been at the forefront. The continent approved biosimilars, for example, nearly a decade before the US. And for cell and gene therapies (CGTs), the European Medicines Agency (EMA) has often given the green light ahead of their regulatory counterparts across the globe. For example in 2022, Europe approved both…

Gamida wins FDA approval for off-the-shelf cell therapy

The US FDA has approved Gamida Cell’s Omisirge (omidubicel), an allogeneic cell therapy for patients with blood cancers who are set to undergo stem cell transplantation. Omisirge is a modified allogeneic cord blood-based cell therapy to quicken the recovery of neutrophils and reduce the risk of infection. It is intended for use in patients with blood cancers planned for umbilical cord blood transplantation following a myeloablative conditioning regimen, such as radiation or chemotherapy. The product, a single intravenous dose composed…

GenSight gene therapy delay due to operation issue at CDMO Thermo Fisher

Share price dropped 32% after GenSight Biologics pushed back proposed regulatory dates because of an undefined operational issue at CDMO Brammer Bio, a subsidiary of Thermo Fisher. Lumevoq (lenadogene nolparvovec) is an intravitreal adeno-associated virus (AAV) gene therapy being developed by GenSight to treat vision loss disease Leber hereditary optic neuropathy (LHON). GenSight had earmarked September 2023 for the possible approval of the late-stage therapy in Europe but has pushed this back to the first quarter 2024 following a production…