Therapeutic Class

BioSymphony No. 1: Oncobiologics Wins First CDMO Deal

Sonnet BioTherapeutics has contracted Oncobiologics to develop and manufacture four undisclosed biologic compounds. The Master Services Agreement (MSA) with Sonnet BioTherapeutics is the first to leverage Oncobiologics’ BioSymphony Platform, consisting of in-house monoclonal antibody (mAb) development and manufacturing capabilities. Lawrence Kenyon, Oncobiologics’ CFO, told BioProcess Insider the platform is used in a small biotech company setting, which results in a “more efficient and timely process for bringing mAbs forward.” He continued: “Our goal, and the purpose of the platform, is…

Sanofi: ‘Ablynx Nanobody Tech Will Fuel Innovation’

Sanofi has completed the acquisition of Ablynx and says it will use the ‘small antibody’ tech platform to drive innovation across a range of therapeutic areas. After rebuffing offers from Novo Nordisk, Belgian biotech Ablynx agreed to an acquisition bid of €3.9 billion (US$4.5 billion) from Sanofi in January. This week, the French pharma giant closed the deal and spoke about its integration plans. “Sanofi and Ablynx have already initiated efforts to better understand the company’s respective areas of expertise…

Plant on the Road to Remediation as Celltrion Resubmits Biosimilars

Celltrion has completed the resubmission of versions of Herceptin and Rituxan to the US FDA after receiving complete response letters for the two biosimilars in April. Earlier this year, the US Food and Drug Administration (FDA) issued complete response letters (CRLs) to South Korean drugmaker Celltrion for its rituximab and trastuzumab biosimilars. The letters cited a warning letter​ sent to the firm in January highlighting “multiple poor aseptic practices” at its production site in Songdo, Incheon. The firm resubmitted CT-P10, a proposed biosimilar…

Lack of Interchangeable Biosimilars Keeps J&J in the Infliximab Game

While US infliximab biosimilars lack interchangeability approval, Remicade (infliximab) can continue to compete in an open market place, says Janssen. Pfizer launched its a biosimilar to Remicade (infliximab), Inflectra, in 2016. The following year, Samsung Bioepis/Merck & Co.’s Renflexis became the second direct threat to Johnson & Johnson subsidiary Janssen’s blockbuster monoclonal antibody. But both products, while deemed by the US Food and Drug Administration (FDA) to be biosimilar to Remicade, have not been approved to be interchangeable with the…

Sanofi Inks $850m mRNA Vaccines Deal with Translate Bio

Sanofi Pasteur has teamed with Translate Bio to develop messenger RNA (mRNA) vaccines for up to five infectious disease pathogens. Under terms of the deal, French vaccine developer Sanofi Pasteur will make an upfront sum of US$45 million (€38 million) to Massachusetts-based firm Translate Bio but total payments could reach $850 million on the back of developmental milestones and royalties. The R&D for the undisclosed vaccine targets will be jointly conducted during an initial three-year period. mRNA vaccines work by…

Automated Tech Ups Hitachi’s Cell Therapy Interest

Recent entrant to the regenerative medicine space Hitachi Chemical has partnered with Invetech to commercialize the Counter-Flow Centrifugation system – an automated platform for cell therapy manufacturing. The partnership will allow customers of Hitachi Chemical Advanced Therapeutics Solutions (HCATS) to access Invetech’s Counter-Flow Centrifugation (CFC) system in the clinical and commercial manufacturing of cell-based therapies using closed single-use disposables. Hitachi entered the regenerative medicine space in 2017 through the $US75 million (€64 million) acquisition of cell therapy contract development and…

Dyadic to Develop Biosimilars Using CHO-Challenging Expression System

Dyadic International has begun developing a pipeline of biosimilars using a fungal expression system it says achieves much higher productivity than CHO cell lines. Dyadic began looking to its enzyme production fungal expression technology for biopharmaceutical purposes in 2015 and has forged several sub-license and partnerships in the biologics space. But now the Florida-based firm has revealed it is set to develop its own biosimilar and biobetter pipeline using the expression system. “We began in earnest an R&D effort on…

First US Neulasta Biosimilar Approval on Second Try for Mylan

The FDA has approved the first US biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim). Mylan’s Fulphila is the tenth biosimilar to be approved in the US. Mylan’s biosimilar, developed with Indian biomanufacturer Biocon, will launch Fulphilia in the coming weeks, spokesperson Julie Knell told BioProcess Insider. “Mylan is the first company to obtain approval for a biosimilar version of Neulasta in the US. Other manufacturers have sought licensure from the FDA but, to our knowledge, do not yet have approval.” She…

Biosimilar Bulletin: EU Success for Sandoz, Amgen Stumbles Stateside

Sandoz says it will use a third-party manufacturer as its proposed Humira biosimilar receives recommendation in Europe. Meanwhile, the US FDA has rejected Amgen’s proposed Herceptin biosimilar. Last Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Halimatoz, Hefiya and Hyrimoz – all versions of AbbVie’s best-selling Mab Humira (adalimumab) submitted by Novartis subsidiary Sandoz. “To ensure the majority of eligible patients gain access to our biosimilar medicines as soon as possible,…

TxCell Opts for Lonza to Make CAR-Treg Clinical Batches

Lacking the resources to manufacture in-house, French biotech firm TxCell has chosen Lonza to produce its HLA-A2 CAR-Treg cellular product, TX200. In February, TxCell finalized its manufacturing process to make Tx200, and began transferring tech to its contract manufacturing organization (CMO). Now the French biotech has revealed the CMO is Lonza, which will manufacture clinical batches of the CAR-Treg product from its production site in Geleen, the Netherlands. TxCell CEO Stephane Boissel told Bioprocess Insider Lonza will produce Phase I/II…