Global Markets

Coming to America: WuXi Biologics Expands Again

WuXi Biologics will construct its first biomanufacturing facility in the US. The US$60 million plant is the third overseas expansion announced in the past month by the Chinese CDMO. Chinese contract development and manufacturing organization (CDMO) WuXi Biologics has rapidly begun expanding its biomanufacturing capacity. A string of investments over the past few weeks will add new capacity in China as well as see the firm venture overseas, including in the US where a US$60 million (€51 million) plant in…

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…

Changing Regulations and ‘Sea Turtles’ Drive China Biotech Boom

Backed by US$260 million, Brii BioSciences is the latest firm benefiting from regulatory and economic changes in China. Insider spoke with expert David Deere to discover why the Chinese market is finally opening up. Funded by a group of six venture capitalists firms, Brii Bio is the latest, and one of the largest, examples of the surge of investment and innovation in Chinese biotech. “Brii Bio aims to accelerate the development and delivery of breakthrough medicines in China through partnerships,…

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,…

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…

‘There is No Life Sciences Equivalent of Apple,’ Horizon Discovery’s New CEO

Horizon Discovery’s new CEO Terry Pizzie says the rate of technology evolution is greater than at any other time in his illustrious career as he reflects on the state of the bioprocessing services industry. Terry Pizzie joined Horizon Discovery Group in 2017 as head of commercial operations, but in May this year he was appointed to the top job. Pizzie has worked in life sciences for close to 30 years and spoke with BioProcess Insider about the changes he has…

WuXi Biologics: Zero to 220,000L of Capacity in 10 Years

WuXi Biologics has invested US$60 million to build a biomanufacturing facility in Singapore. By 2022, the CDMO will have 10 plants – an achievement it attributes to disposable and modular technologies. WuXi Biologics has announced plans to add a S$80 million (US$60 million) clinical and commercial biologics manufacturing in Singapore to its growing global network. When operational, the site will boast 4,500 L biomanufacturing capacity comprised of two 2,000 L traditional fed-batch and one 500 L perfusion based continuous processing…

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…

Multi-Media Player: GE Invests in EU and US Plants to Tap $1.4bn Market

The increased demand for cell growth media from biomanufacturers has driven capacity expansions at sites in Utah and Austria, says GE Healthcare. Globally, GE Healthcare has cell culture media production in Tuas (Singapore), Pasching (Austria), and Logan (Utah, US). To support growing demand from the biopharma industry, the life sciences firm has announced capacity expansions at the two latter plants. “Cell culture media is the fastest growing segment within the cell culture market and it was valued at US$1.4 billion in…