Monday, June 4, 2018 Daily Archives

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…