Therapeutic Class

FDA Greasing the Wheel for Biosimilar Adoption Through Action Plan

The US FDA has published an action plan to promote and expedite biosimilar competition. Healthcare consultant Steven Lucio tells us “we are at a critical point in time in the biosimilar development landscape.” Last week, the US Food and Drug Administration (FDA) published a ‘Biosimilars Action Plan’ aimed at promoting access to lower-cost biosimilar drugs while maintaining a desire for new biologics innovation. “By enabling a path for competition from biosimilars, we also give innovators an added incentive to invest…

Neupogen Biosimilar Success: Pfizer Banks on Discounts and Patient Confidence

The US Food and Drug Administration (FDA) has approved Pfizer’s Nivestym; a second biosimilar of Amgen’s Neupogen (filgrastim). In March 2015, the FDA approved its first biosimilar: a version of Neupogen called Zarxio, marketed by Novartis subsidiary Sandoz. Three years later and a second filgrastim biosimilar is close to being available after the FDA approved Pfizer’s product NIvestym. A spokesperson from the Biopharma firm told BioProcess Insider Pfizer will be able to compete against both Amgen’s reference biologic and Sandoz’s…

Univercells $19m Booster Shot to Help Disrupt Vaccine Industry

Traditional vaccine makers have limited incentive to invest in new technologies and processes says Univercells, which hopes to advance its own viral vaccines produced in micro-facilities. Univercells has raised €16 million (US$18.7 million) of funding in a Series B financing round led by Global Health Investment Fund. Some of the capital will be used to increase the impact of its proprietary viral platform through the expansion of its portfolio. “Following the platform proof of concept, with its sIPV development program…

‘Dramatic’ Gene Therapy Demand Drives Viral Vector Delays

Some gene therapy developers are waiting more than a year for viral vectors due to the shortage in third-party services, says European CDMO Yposkesi. French contract development and manufacturing organization (CDMO) Yposkesi claims to have the largest industrial platform for the GMP manufacture of viral vectors for gene therapies in Europe. The firm has four independent production suites and two fill & finish suites, with current capacity of 35 batches per year. And now the manufacturer is set to grow…

FDA Guidelines Show ‘Growing Maturity’ of Gene Therapy Space, Says Industry

The US FDA has published six draft guidance documents related to gene therapies. The inclusion of manufacturing guidelines will help modernize the commercialization process to keep pace with the growth technology, say industry groups. Over the past 12 months, the US food and Drug Administration (FDA) has approved three separate gene therapy products: Novartis’ Kymriah (tisagenlecleucel), Gilead/Kite’s Yescarta (axicabtagene ciloleucel), and Spark Therapeutics’ Luxturna (voretigene neparvovec). And with a growing number of gene therapies moving through the clinic – there…

Still Space for Multiple Neulasta Biosimilars, says Pfenex

Pfenex has deprioritized its pegfilgrastim biosimilar program but is reevaluating the market after Mylan’s recent success in the US. In June, the US Food and Drug Administration approved Mylan’s Fulphilia on its second attempt. While Fulphilia has become the first biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim), there are several other firms looking to tap the market, including Coherus and Novartis subsidiary Sandoz. Clinical-stage development and licensing biotech Pfenex too has a pegfilgrastim biosimilar in its pipeline, PF529, but announced…

Therapy First, Efficiency Second: Why We Should Stop Focusing on Manufacturing Costs

Drug substance manufacturing only contributes around 5% on average to the total cost of a biologic says GE Healthcare’s Guenter Jagschies. Payors, patients and governments are increasingly looking to industry to justify the high prices of prescription drugs. As new immuno-oncology treatments are being launched with increasingly higher price tags and often the cost of producing these complex biotherapeutics. “This industry is not pricing based on cost, it is pricing based on perceived value,” Guenter Jagschies, senior director of strategic…

Hyperstack Shortage Caused by Gene Therapy Surge

The adoption of viral vector technology in cell and gene therapy has led to six month waiting lists for multilayer culture vessels. Hyperstack vendor Corning says it will more than double its manufacturing capacity to deal with the demand. Despite being a registered brand owned by Corning Life Sciences, ‘hyperstack’ has become a common term to describe multilayer, scalable, and single-use culture flasks. They are used to produce viral vectors and gene therapies, and are in huge demand, according to…

FDA Seeks Injunctions in Fight Against $2.4bn Unapproved Stem Cell Market

Industry group International Society Cell and Gene Therapy (ISCT) has supported regulatory actions aimed at permanently closing two unapproved US stem cell clinics. The US Food and Drug Administration (FDA) is seeking a permanent injunction against Sunrise, Florida-based US Stem Cell Clinic LLC and Californian firm California Stem Cell Treatment Center Inc for marketing stem cell products without approval. The actions are the latest in a crackdown by the regulator on unproven cellular therapies (UCT) and complement a suite of…

Humira Biosimilars: Amgen Lawsuit ‘Stake in the Ground’ for Others

Amgen will challenge AbbVie’s bestseller Humira in the US from 2023, following a lawsuit settled last year. Other adalimumab developers are likely to receive the same deal, an IP lawyer says. In September 2017, Amgen and AbbVie reached a settlement resolving all pending litigation in relation to the former’s Amjevita, a biosimilar version of the latter’s top-selling monoclonal antibody Humira (adalimumab). Amjevita became the third biosimilar to approved by the US Food and Drug Administration (FDA) in September 2016, but…