Author Archives: Dan Stanton

Amgen US Humira biosimilar arrives five months ahead of the pack

Amgen has launched Amjevita with a two-tier list price strategy offering the biosimilar at discounts of 55% and 5% over AbbVie’s Humira (adalimumab). After 20 years and over $200 billion of sales, AbbVie’s anti-TNF-α monoclonal antibody Humira is facing competition in the US with the launch of Amjevita. “Today, we announced the launch of Amjevita, the first US biosimilar to Humira, a medicine used by more than 1 million patients living with serious inflammatory diseases,” Amgen’s EVP of Global Commercial…

CMC and staffing must be resolved if CGTs are to go ‘supersonic’

CMC deliverables must be addressed to continue CGT momentum, but overcoming talent gaps will give firms the competitive edge, says former Spark Therapeutics CTO Cynthia Pussinen. With 10 approvals in the US and Europe last year, there is little doubt the cell and gene therapy (CGT) sector is blossoming. Consultant Cynthia Pussinen described the sector as having “lifted off and in flight” at Phacilitate’s Advanced Therapies Week earlier this month, with much progress including “truly rewriting how patients are treated…

Sartorius plans $500m+ CAPEX and eyes M&A opportunities in 2023

Sartorius invested €593 ($647) million in its global capacities in 2022 and says it is planning similar this year. For the full year 2022, Sartorius reported total sales of €4.17 billion, representing a 21% increase on the previous year. The firm’s Bioprocess Solutions business pulled in €3.32 billion of this and saw a 22% growth year-on-year. The firm reiterated how the skew of COVID-19 related revenues and demand normalization will drive down sales going forward, with CEO Joachim Kreuzburg forecasting…

CGT myth-busting: ‘The process is NOT the product’

Deeper characterization and quality-by-design (QbD) approaches demonstrate the cell and gene therapy space has outgrown the lazy ‘process is the product’ rhetoric, say experts. Journalists and industry alike have clung onto the concept that ‘the process is the product’ when it comes to cell and gene therapies (CGTs). For years, the catchy phrase has been banded around convention centers and company boardrooms but as the field matures – 10 CGTs won approval in the US and Europe last year –…

WuXi ATU wins tech disruptor at #ATW awards in Miami

A transfection-free and scalable AAV technology has bagged WuXi ATU the Manufacturing Tech Disruptor of the Year Award at the first Advanced Therapies Awards ceremony. Miami, Florida’s famous Fontainebleau Hotel hosted the integral Advanced Therapies Week (ATW) Awards event last week, honoring progress and success in cell and gene therapies. Highlights of the evening including the presentation of the Lifetime Achievement Award to Carl June – the cell therapy pioneer and Time Magazine ‘Person of the Year’ runner-up 2016, who…

Top 10 CGT markers 2022: Approvals aplenty but patient access remains limited

Big Pharma mobilization and a series of approval firsts dominated the seasonal cell and gene therapy review, but failures in patient access post-commercialization took the top spot. In what has become a highlight of Phacilitate’s Advanced Therapies Week, Susan Nichols, chief business officer at ViroCell Biologics, highlighted 10 events from 2022 that drove conversation, investment, and innovation in regenerative medicine. She told delegates in Miami, Florida the past 12 months saw “the highest of the highs” in the cell and…

Aton Bio: China pharma backed CDMO with a startup spirit

Aton Biotech hopes to make big waves in the bio-CDMO space by leveraging up to 144,000 L of bioreactor capacity from parent company Shanghai Henlius Biotech. Henlius operates two biomanufacturing in Shanghai with a total of 48,000 L of bioreactor capacity, along with fully integrated drug substance and drug product capabilities. The firm broke ground on a third 130,000 square meter facility last year, the first phase of which will incorporate 36,000 L of biomanufacturing capacity comprising of up to…

10 CGT approvals in 2022 brings ‘Gottlieb’s math’ close to realization

With cell and gene therapies coming of age, experts at Advanced Therapies Week looked to reducing COGs, novel payer models, and even biosimilars to tackle their spiraling price tags. In 2022, there were 10 approvals between the US and Europe for nine cell and gene therapy products: Adstiladrin, Breyanzi, Carvykti, Ebvallo, Hemgenix (approved by both FDA and EMA), Roctavian, Skysona, Upstaza, Zynteglo. As such, optimism was high at Phacilitate’s Advanced Therapies Week, held this week in Miami, Florida. “We’ve gone…

Amgen prepped to take first slice of AbbVie’s US Humira pie

Amgen is eyeing up a share of the $17+ billion US adalimumab market with the prospective launch of the first Humira biosimilar, Amjevita, later this month. In its trend report ‘Drugs to watch 2023,’ Clarivate highlights the impending loss of exclusivity of AbbVie’s bestselling drug Humira (adalimumab). The monoclonal antibody has clocked in sales of more than $200 billion for AbbVie (and previously Abbott) since its launch in 2003, with 2021 sales alone pulling in $20.1 billion in sales, $17.3 billion…

Novartis at JPM: ‘7-day CAR-T process an alternative to allogeneic’

With its next-generation CAR-T manufacturing platform, Novartis told JP Morgan Conference delegates it has no plans to move into the allogeneic space. Novartis is one of the pioneers in the chimeric antigen receptor (CAR) T-cell space, bringing the first therapy to market in the US in 2017: Kymriah (tisagenlecleucel), a treatment for B-cell acute lymphoblastic leukemia (ALL). Since then, a handful of other cell-based gene therapy products have been approved by the US Food and Drug Administration (FDA) but all…