Therapeutic Class

Valerius Picks Catalent to Make ‘Specialty Biosimilar’ Pipeline

High productivities and specialized targets means Catalent’s 2,000 L scale bioreactors can easily realize production needs for its orphan biosimilar and biobetter candidates, says Valerius Biopharma’s CEO. Swiss biopharma firm Valerius Biopharma has selected Catalent Biologics to provide cell line development and cGMP manufacturing for its burgeoning biosimilar pipeline. The firm has not disclosed the specific targets but CEO Andreas Herrmann told BioProcess Insider “two are biosimilars of orphan drugs and the other two are products, where we want to…

First US Epogen Biosimilar Approved as Pfizer Fixes GMP Issues in Kansas

The FDA upgraded Pfizer’s troubled McPherson, Kansas facility in January paving the way for the approval of Retacrit – a biosimilar version of Amgen’s Epogen (epoetin alfa). The US Food and Drug Administration (FDA) approved Retacrit as the first biosimilar version of Amgen’s anemia drug Epogen yesterday. “The FDA’s decision to approve Retacrit for all indications of the reference product marks a critical and positive step forward in helping create a marketplace for biosimilars in the US, further advancing opportunities…

Lilly Buys Back Early Phase Oncology Kinase in $110m AurKa Deal

Eli Lilly adds AK-01 – an Aurora kinase A inhibitor it originally discovered – to its early-stage pipeline. The acquisition comes days after Lilly bought Armo BioSciences for US$1.6 billion. In 2016, biopharma giant Eli Lilly sold AK-01 to venture capital firm TVM Capital Life Science, which went on to establish AurKa Pharma. This week, the firm has announced it is buying it back through the acquisition of AurKa. The is an Aurora kinase A inhibitor being tested in multiple…

Rise of the Insects: Thermo Fisher Hails Non-Mammalian Expression for Vaccines

Encouraged by success of Flublok and Cervarix, Thermo Fisher says insect protein expression systems are one of the most promising technologies being used in the development of next-generation vaccines. Thermo Fisher has launched the Gibco ExpiSf system, an insect protein expression system aimed at generating baculovirus using a suspension-based transfection protocol it says delivers protein in half the time compared to traditional insect platforms. BioProcess Insider spoke with Amy Butler (AB), vice president and general manager, Cell Biology at Thermo…

Samsung BioLogics: Rise of Biosimilars Behind Bioepis Accounting Change

Samsung BioLogics says it did not violate accounting rules. Change in its financial reporting related to plans by Biogen to up its stake in biosimilar JV, Samsung Bioepis. South Korea’s Financial Supervisory Service (FSS) released a preliminary statement last week accusing contract development and manufacturing organization (CDMO) Samsung BioLogics of accounting fraud. The special yearlong audit investigated a turnaround in Samsung BioLogics’ financials, when after years of losses it reported profits of KRW 1.9 trillion (US$1.8 billion) in 2015 ahead…

Lonza Building Hybrid Biomanufacturing Plant at NH Site

Lonza plans to bolster its mid-scale biomanufacturing and cell therapy capabilities at its site in Portsmouth, New Hampshire on the back of growing demand. The expansion will include mid-scale mammalian capacity through the installation of several 6,000 L bioreactors which will eventually replace stainless steel 5,000 L systems operating at the site. “This will be a hybrid facility combining stainless steel for the main reactor with single use technologies for some of the upstream and downstream processing,” Sylke Hassel, SVP…

Teva: Migraine Mab Delay After ‘Negative Surprise’ of Celltrion Warning

Manufacturing issues are likely to delay the approval of fremanezumab but Teva remains confident its migraine drug will launch this year. Teva Pharmaceutical Industries’ monoclonal antibody (mAb) candidate fremanezumab is under regulatory review as a preventive treatment for chronic migraine. The US Food and Drug Administration (FDA) has assigned fremanezumab a Prescription Drug User Fee Act (PDUFA) action date mid-June, but the firm announced yesterday it expects a delay on the decision due to manufacturing issues. “There’s not much doubt about…

Sandoz Receives CRL for Rituxan Biosimilar

Novartis’ Sandoz remains committed to further discussions with the US FDA after receiving a complete response letter (CRL) for its rituximab biosimilar candidate. The Biologics Licensing Application (BLA) for Sandoz’ proposed biosimilar of Roche’s autoimmune disease drug Rituxan (rituximab) suffered a setback yesterday when the US Food and Drug Administration issued a CRL. A Sandoz spokesperson told BioProcess Insider that the firm is “still evaluating the content” of the letter and specific details are not being divulged for now. “The…

Jazz Pays Spark $110m for Luxturna Priority Review Voucher

Spark Therapeutics has sold its Rare Pediatric Disease Priority Review Voucher (PRV) to Jazz Pharmaceuticals for US$110 Million (€92 million). Spark Therapeutics received the PRV from the US Food and Drug Administration (FDA) when its gene therapy for inherited retinal disease, Luxturna (voretigene neparvovec), was approved. But the firm disclosed in an SEC filing it is selling the voucher to Ireland-headquartered biopharma firm Jazz to help support its future R&D. “We will invest the proceeds from the sale back into the…

Beyond Adcetris: Seattle Genetics Aiming for Big Biopharma Status

Profitability will be placed on the backfoot as Seattle Genetics looks to grow into a “powerful big expansive company,” the firm says. For the first quarter 2018, total revenues grew to US$141 million (€116 million) compared to $109 million in the same period last year. This was attributed to a 36% increase in sales of Seattle Genetics’ antibody-drug conjugate (ADC) Adcetris (brentuximab vedotin), which pulled in $95 million of sales. Total costs for the quarter, meanwhile, jumped by almost 30%…