Interested in moving from small to large molecule manufacturing? An upcoming course will address mAb characterisation challenges and offer hands-on experience for small molecule manufacturers , says NIBRT, Ireland’s biomanufacturing training centre.
Industry’s uptake of stainless steel systems continues to fall as biomanufacturers move away from large volume blockbuster biologics, according to GE Healthcare.
Pfizer remains confident it will launch its biosimilar Inflectra in the US this year despite J&J assuring stakeholders it will defend Remicade’s IP beyond 2018.
Fully understanding a molecule’s mode-of-action (MOA) will be essential as industry begins developing the third generation of biosimilar products, according to Formycon.
Biosimilar acceptance among physicians has doubled to 80% since 2013, according to a survey presented at by copycat biologic distributor Celltrion Healthcare.
The partnership with recombinant protein development firm GTP Technologies will create an end-to-end manufacturing service, speeding up production of monoclonal antibodies and reducing costs, says Novasep.
Celltrion’s supply chain and warehousing procedures ensure the safe storage of Remicade biosimilars as demand fluctuates across markets, the drugmaker says.
It is still too early to tell how big an impact biosimilars will have in the US, according to an IP lawyer, a year after the FDA approved Sandoz’s Zarxio.
JHL has completed “mechanical construction” of an off-the-shelf mAb plant in Wuhan, China days after UK regulators gave the go ahead for a trial of its rituximab biosimilar, JHL1101.
Yan Mei, a defendant charged with stealing GlaxoSmithKline (GSK) trade secrets including biopharmaceutical manufacturing processes, remains at large, a spokesperson for the US Attourney's office told us yesterday.
Having a proactive approach to delivery technologies will give pharma firms a competitive edge against biosimilars and biobetters, according to device maker Bespak.
Abzena is set to buy The Chemistry Research Solution (TCRS) in a deal one analyst says shows the firm’s intentions to dominate the bio-conjugation space.
Epirus is set to file its Remicade biosimilar in 2017 and says the $3bn market will remain a large opportunity despite growing entrants in infliximab development.
Humira's extensive estate of over 70 formulation, manufacturing and method of treatment patents will keep US competition at bay until at least 2022, says AbbVie.
Regeneron Pharmaceuticals will use it speedy mAb development tech to move an Ebola drug into clinical trials under a $38m (€34m) US Government contract.
A copycat version of Amgen’s Enbrel has been approved in Korea, marking the first regulatory success for Merck & Co and Samsung Bioepis' biosimilar joint venture.
Repligen could reap the financial rewards from two recently approved cholesterol-lowering proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors, a Jefferies analyst says.
Remicade biosimilars have had no meaningful impact on AbbVie’s parallel TNF inhibitor Humira, management says, despite international Q2 sales of the mAb being down 14% year-on-year.
A surge of demand in biologics contract testing and biosimilar characterization has caused BioOutsource to double its capacity with the opening of a new facility in Glasgow, Scotland.
Alexion will expand its manufacturing network with a €450m ($507m) biologics facility in Ireland, a week after entering an $8.4bn agreement to acquire Synageva.
Oncobiologics, a biotherapeutics company focused on developing and commercializing monoclonal antibody (mAb) biosimilars, has completed the construction of its GMP commercial manufacturing facility at its headquarters in Cranbury, New Jersey.
Merck & Co. will invest €11.5m ($12.5m) at a plant in Ireland to manufacture its oncology drug Keytruda, an anti-PD1 mAb recently approved by the US FDA.
Data must drive US FDA efforts to determine biosimilar interchangeability according to a Pfizer exec who told Goldman Sachs conference delegates not to expect a definition anytime soon.
The US FDA has delayed an advisory committee review of Celltrion's Remicade (infliximab) biosimilar after asking the South Korean drugmaker for more information.
Mundipharma’s associate Napp Pharmaceuticals launched Celltrion’s Remicade biosimilar Remisma in the UK today, just 24 hours after the originator lost patent protection.
The US FDA has set a date to review its first monoclonal antibody (mAb) biosimilar: a version of J&J’s Remicade marketed by Pfizer takeover target Hospira.
Repligen has finished an expansion at its US filtration system facility eight months after bolstering its offering in this area by buying a platform from Refine Technology.