Samsung Bioepis has received European Commission approval for Ontruzant, its version of Roche’s best-selling breast cancer mAb Herceptin (trastuzumab).
Peregrine Pharmaceuticals will become a pure-play CDMO under the name Avid Bioservices and is looking to sell or license its pipeline, including investigational monoclonal antibody bavituximab.
Mvasi has been recommended for approval in Europe, but a duplicate marketing authorisation application for an Avastin (bevacizumab) biosimilar has been withdrawn by Amgen.
Pall Corporation will equip WuXi Biologics’ continuous bioprocess laboratory in Shanghai, China, which the latter said would expand process scale and reduce manufacturing costs.
Teva says it has increased the lifespan of its Protein A resin and thus reduced the cost of manufacturing monoclonal antibodies by tweaking its cleaning materials.
GE Healthcare has launched a Protein A resin it says can improve monoclonal antibody purification capacity by up to 40% compared to its current offering.
US regulators have approved Amgen Inc’s Mvasi (bevacizumab-awwb), a biosimilar version of Roche’s monoclonal antibody (mAb) cancer treatment Avastin (bevacizumab).
The US FDA has approved its sixth biosimilar and second version of AbbVie’s best-selling monoclonal antibody Humira (adalimumab): Cyltezo, made by Boehringer-Ingelheim.
“One of the most productive arrangements in the history of the biotechnology industry” will end, says Regeneron on its monoclonal antibody collaboration with Sanofi.
The US FDA has accepted submission of two further Herceptin (trastuzumab) biosimilars: ABP 980 developed by Amgen and Allergan, and Teva and Celltrion’s CT-P6.
Roche is confident its biologics pipeline and plan to reformulate some of its top selling monoclonal antibodies can offset sales erosion resulting from biosimilar competition.
A tobacco plant-based platform could make monoclonal antibodies up to 90% cheaper than mammalian systems, says Axis Biotec which is building a pilot plant in Brazil.
Bestselling biologic Remicade (infliximab) will remain a multi-billion dollar product for J&J for at least the next five years, even with biosimilar competition the firm says.
Sanofi and Lonza will construct a large-scale mammalian cell culture manufacturing site in Switzerland, with an initial investment of CHF 290m ($288m).
The European Commission has approved Celltrion Healthcare’s rituximab biosimilar – Truxima (CT-P10) – for the same autoimmune disease and cancer indications as the reference product.
Biocon's second fill/finish line at Bangalore site to come online later this year
Biocon’s biomanufacturing facilities in India will need a “meaningful capacity expansion” to cope with long-term global biosimilar demand, the firm says.
Johnson & Johnson has predicted a 10-15% erosion in sales of Remicade (infliximab) in 2017 following Pfizer’s “at-risk biosimilar launch of Inflectra.”
Bruker has bolstered its molecular biologics and mass spectrometric offering through the acquisition of contract manufacturing organisation (CMO) InVivo Biotech.
Celltrion is confident that 2017 will bring European approval and a US filing for Truxima, after achieving regulatory success for the Rituxan biosimilar in Korea.
The rejection of a petition against a Humira formulation patent is problematic for Coherus but may not affect other adalimumab biosimilar developers, an analyst says.
CMC Biologics and IDT Biologika have added Cerbios-Pharma SA and Oncotec Pharma Produktion GmbH to the companies’ PROVEO Partnership – a strategic collaboration for manufacturing antibody drug conjugates (ADCs).
Teva has partnered with Celltrion to commercialise versions of Roche’s Herceptin and Rituxan, helping fill a gap in its second wave biosimilars pipeline.
The EMA will assess a version of Roche’s breast cancer drug Herceptin (trastuzumab), the fifth biosimilar candidate submitted for review by Samsung Bioepis.
J&J cannot stop Inflectra arriving in the US in October but warns Pfizer of the risk of launching it while the patent surrounding Remicade’s manufacture remains unresolved.
Custom-made affinity resins can offer biomanufacturers flexibility and shorten development timelines says Avitide, fresh from securing Series D financing from Mithril Capital Management.
Lucentis biosimilar developer Formycon saw its share price jump 16% days after Pfizer abandoned efforts to create a rival version of Roche's blockbuster eye drug.
Catalent and Zumutor Biologics have combined their technologies to create antibodies with enhanced Antibody Dependent Cellular Cytotoxicity (ADCC) without compromising production levels.
High US approval rates of monoclonal antibodies is driving demand for Protein A, and with the arrival of biosimilars this is unlikely to slow down, says Repligen.