Did you miss any of the biosimilar approvals, launches or guidance this year? Well Biopharma-Reporter brings you a special timeline of events to help guide you into the new year.
Spark Therapeutics has received US approval for Luxturna (voretigene neparvovec-rzyl), its one-time gene therapy treatment for an inherited form of vision loss.
Antibody-drug conjugates (ADCs) are one of the “hottest areas of research” says STA Pharmaceutical and WuXi Biologics which are investing in conjugation and fill/finish capabilities in China.
TxCell SA has developed the production process for it range of CAR-Treg based therapies and is preparing to transfer it to its CMO ahead of first-in-human trials.
Merck KGaA says it will provide technology and training to a local team in Sub-Saharan Africa, to help establish a dedicated human vaccine manufacturing facility.
Yposkesi will make lentiviral vectors for Orchard Therapeutics’ gene therapies – indicated to treat primary immunodeficiencies – at its facility near Paris, France.
Harpoon Therapeutics has selected CMC Biologics to develop and manufacture three molecules for cancer treatments at the CDMO’s facilities in California and Washington State, US.
Eli Lilly has projected an increased spend across its biomanufacturing network next year to support bulk production and fill/finish of monoclonal antibodies.
Teva Pharmaceuticals Australia has selected Berkeley Lights’ biological workflow platform to develop therapeutic antibodies at its R&D site in New South Wales.
Pfizer says it remains committed to Inflectra and partner Celltrion after gaining US FDA approval for another infliximab biosimilar, Ixifi, developed in-house.
The US FDA has approved Admelog as a follow-on drug five months after it received European market authorisation as a biosimilar of Eli Lilly’s Humalog (insulin lispro).
The world’s largest single bioproduction plant has received its first EU regulatory approval to make a monoclonal antibody, says CDMO Samsung Biologics.
CAR T developers must be involved throughout the entire supply chain says Kite Pharma, which depends on accreditation and training programmes across its network of Yescarta administration clinics.
Abzena has negotiated the lease on a 50,000 square foot site in San Diego as part of a $17m remodelling of its bioproduction and conjugation facilities.
Plasticell has teamed with Anthony Nolan to access the latter’s cord-blood bank and boost patient recruitment for its allogeneic haematopoietic stem cell transplantation (HSCT) therapy trials.
CSL opens a $173m albumin plant in Australia, Kiadis leases a facility in The Netherlands, and ADC Bio signs a construction agreement in Wales. Welcome to Biopharma-Reporter’s facility round-up.
Vendors say they are open to considering a singular, industry-wide design for disposable bioreactor equipment, IP concerns and customised demands could impede its adoption.
Roche, Merck and Lilly are among those calling for regulatory harmonisation and free movement of goods between the EU and the UK once the latter leaves the Union.
Innova Biosciences says its Lightening-Link tech helps customers not to waste expensive reagents in antibody conjugation as it inks a supply deal with US Biological.
The Korean CDMO says construction of its third – and largest – biomanufacturing facility is complete with the validation process expected to take a year.
The EMA has accepted to review Mylan’s trastuzumab and pegfilgrastim biosimilars amid remediation efforts at biomanufacturing partner Biocon’s fill and finish plant in India.