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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

by Dan Stanton

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

by Dan Stanton

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

by Dan Stanton

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

by Dan Stanton

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

by Dan Stanton

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

by Dan Stanton

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%…

Complex Sandostatin Manufacturing Holding Off Competition, Novartis

by Dan Stanton

The complexity to manufacture the growth hormone inhibiting peptide Sandostatin will ensure protection from competition, says Novartis. 2017 sales of the acromegaly peptide Sandostatin (octreotide) were down slightly on the previous year, but still brought in US$1.6 billion (€1.3 billion) for Swiss biopharma Novartis. During the firm’s recent first quarter financial call, board member Elizabeth Doherty told stakeholders that while the firm is always looking at potential risks from competition, “we know ourselves with our own experience how difficult it…

AbbVie Braces for 20% Erosion as EU Humira Biosimilars Assemble

by Dan Stanton

AbbVie expects impact from Humira (adalimumab) biosimilars in Europe beginning the fourth quarter but remains confident there will be no direct US competition until 2022. AbbVie is preparing for Humira biosimilar entrants beginning in the fourth quarter 2018, the firm said during a first quarter conference call. A settled lawsuit with Samsung Bioepis earlier in the quarter laid the way for the Korean firm’s adalimumab biosimilar Imraldi to be launched as soon as October 16 by commercialization partner Biogen. Meanwhile,…

Another Biosimilar CRL for Pfizer, but Manufacturing not the Cause

by Dan Stanton

Pfizer has received a US FDA complete response letter (CRL) for its proposed version of Roche’s breast cancer monoclonal antibody Herceptin (trastuzumab). Pfizer announced its biologics license application (BLA) for PF-05280014 has been turned down by the US Food and Drug Administration (FDA), with the agency highlighting the need for additional technical information in the CRL. The requested information does not relate to safety or clinical data, Pfizer said in a release. The news comes less than a year after…