Therapeutic Class

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…

Bavarian Nordic: Smallpox Vaccine Plant ‘Encouraged’ by US Government

Bavarian Nordic is constructing a US$75 million fill & finish facility in Denmark on the back of future US government contracts to supply smallpox vaccine Imvamune. Last September, the US government’s Biomedical Advanced Research and Development Authority (BARDA) awarded Danish vaccine manufacturer Bavarian Nordic a contract for the manufacturing and storage of its smallpox vaccine Imvamune. The deal, worth more than $539 million (€460 million), is the third such award to manufacture vaccine bulk to the US Department of Health…

Topical Herpes Virus-Based Gene Therapy Granted FDA Fast Track

Krystal Biotech’s lead candidate has received FDA fast track designation for the treatment of dystrophic epidermolysis bullosa (DEB). The firm is building a GMP facility in Pennsylvania to support future scale-up. The US Food and Drug Administration (FDA) granted fast track designation to KB103, a topically-applied gene therapy engineered to deliver a human collagen protein to patients suffering from DEB. The designation will help expedite the development and review process of the allogeneic gene therapy, and is a boost for…

Fujifilm Adds Automated Filler for Late-Stage Gene Therapies at Texas Plant

Recent gene therapy approvals have driven the demand for third-party services, says Fujifilm as it expands fill & finish capabilities at its recently opened site. In January 2018, Fujifilm Diosynth Biotechnologies opened an 80,000 sq-ft facility in College Station, Texas, for the manufacture of gene therapies. This week, the contract development and manufacturing organization (CDMO) has expanded the plant to support the fill & finish of Phase III and commercial products by adding a Vanrx Pharmasystems’ SA25 automated filler. “We…

Gilead Flies a Kite for ZFN Gene Editing Tech Over CRISPR

Gilead’s CSO spoke about its choice of zinc finger nuclease (ZFN) for ex-vivo gene editing at the Bank of America Merrill Lynch Healthcare Conference. In February, Kite Pharma – acquired by Gilead Sciences for US$11.9 billion in last August – struck a deal to use Sangamo Therapeutic’s ZFN technology to modify genes in the development of its autologous and allogeneic cell therapies. Kite/Gilead paid $150 million up front to the fellow Californian firm but Sangamo could be entitled to a…

Novartis Building $55m gene therapy plant, Creating 200 Jobs in NC

A week after buying AveXis, Novartis has announced plans to build a gene therapy manufacturing facility in Durham, North Carolina. On May 15, Swiss Biopharma Novartis confirmed the completion of the US$8.7 billion (€7.4 billion) acquisition of clinical stage gene therapy firm AveXis. A week later, Novartis has unveiled plans for a $55 million gene therapy production plant in Durham, North Carolina to support AveXis’ gene therapy pipeline targeting rare neurological genetic diseases. AveXis’ lead candidate AVXS-101, in development for…

Biogen Paying $650m to Up Stake in Samsung Bioepis

Biogen has opted to increase its control in biosimilar venture Samsung Bioepis to 49.5%, according to partner Samsung BioLogics. Biogen sent South Korean biomanufacturer Samsung BioLogics a letter last week declaring its intention to increase its stake in the firms’ joint venture Samsung Bioepis from 5.4% to 49.5%. According to Samsung BioLogics, Biogen will pay around 700 billion Won (US$650 million) for an additional 44.6% stake in the JV, with the deal expected to take two to three months to…

Coherus Resubmits Neulasta Biosimilar, Aims for November Approval

With successful preapproval inspections at its manufacturing sites, Coherus BioSciences is confident its CHS-1701 pegfilgrastim biosimilar will be approved by the end of the year. In 2017, California-based Coherus received a US Food and Drug Administration (FDA) complete response letter (CRL) for its version of Amgen’s Neulasta (pegfilgrastim), CHS-1701. The CRL requested a reanalysis of a subset of subject samples with a revised immunogenicity assay, along with additional manufacturing related process information. Earlier this month, Coherus announced it resubmitted its…