So far most biosimilars filed in the US have been ‘low risk’ according to contractor BioOutsource, which warned that developers seeking approval for copycat mAbs face higher legal and regulatory hurdles than in Europe.
Sanofi has selected Boehringer-Ingelheim to manufacture monoclonal antibodies in an agreement that extends to the French drugmaker's partner Regeneron.
Peregrine Pharmaceuticals is expanding its contract manufacturing capacity to meet growing client demand and to produce its own monoclonal antibody bavituximab, the company has revealed.
Single-use continues to be adopted by the bioprocessing industry, but drugmakers are still hesitant to use disposable chromatography systems, says EMD Millipore.
Despite plans to lay off more than 2,000 employees, Amgen is preparing for a biosimilar onslaught and expanding its portfolio to nine biosimilar programs.
The EGA has called for more awareness surrounding the uptake of biosimilars in Europe after a report has shown upcoming products could cut healthcare provider spending by a quarter.
Reliance Life Sciences has been contracted to make the first Indian biosimilar of J&J’s Remicade (infliximab), though Epirus Biopharmaceuticals says it is looking to Fujifilm for its European supply.
European authorities have revoked a Regeneron patent covering a genetic modification technique used to generate mouse monoclonal antibody (mAb) production platforms after an appeal by several European firms.
At present Biosimilars save Europe roughly €2.40 per person, or €1.8bn a year, but by 2020 follow-on mAbs alone will shave €20bn off the continent’s healthcare bill according to researchers.
The monoclonal antibody drug Soliris has been recommended by NICE despite Alexion failing to justify the manufacturing costs contributing to the £3,150 ($5,140) price per vial.
Amgen says it will continue to invest in manufacturing technologies to support its biosimilar pipeline despite announcing a restructuring that will reduce its manufacturing footprint by 23%.
Interest in creating alternatives to Protein A has waned in light of more viable cost-saving opportunities in bioprocessing, such as single-use adoption, says Repligen.
Ono Pharmaceuticals has received approval for Opidvo (Nivolumab) in Japan becoming the first biopharma to bring a fully human PD-1 monoclonal antibody to market.
Alexion says it has provided NICE with the R&D and manufacturing information it asked for ahead of the second assessment of its £3,150-a-vial rare blood disorder drug Soliris next month.
Biosimilars will not deliver the same cost savings as generic drugs and may not even gain a strong foothold in the biologics market until 2019, according to a new report from GlobalData.
Potentially valuable monoclonal antibodies (mAbs) may find difficulties with administration due to high viscosity, though researchers are now turning to neutron spin echo instruments to gain a better understanding of what is occurring, according to new...
In what it says “is a milestone for the Chinese Biologics industry,” WuXi PharmaTech beat off bids from Lonza and Boehringer Ingelheim to make a monoclonal antibody for TaiMed
Development of new anti-choloesterol drugs containing proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibiting monoclonal antibodies could double Repligen Bioprocessing’s earning power, according to a Jefferies analyst.
The High Court in London has revoked two patents referring to the dosage and composition of Roche’s monoclonal antibody drug Herceptin, paving the way for Hospira’s biosimilar product.
Takeda has licensed a biodegradable polymer and customisable linker platform from Mersana Therapeutics who says the tech offers advantages over other antibody-drug conjugate (ADC) approaches.
An expression system developed by Cevec Pharmaceuticals has achieved 'very high' titres and bypassed problems that beset other platforms, moving the possibility of a commercial respiratory syncytial virus (RSV) one step closer.
Inflectra has been launched in Central and Eastern Europe (CEE) and, as the world’s first monoclonal antibody biosimilar drug goes from strength-to-strength, has also been approved by Health Canada.
The US Food and Drug Administration (FDA) has issued Amgen with a Warning Letter at its Thousand Oaks, California plant citing violations in the production of monoclonal antibody combination products.
BioOutsource says it has quadrupled its revenue from biologics testing and biosimilar characterisation in the last 18 months and is opening a new facility to cope with continued demand.
A new vitamin E-based hydrogel technology could improve how cancer busting mAbs are delivered and help biopharmas cut costs according to developer IBM.
Biotech developer Regeneron is investing as much as $300m in its New York manufacturing plants and for a new site in Ireland as part of preparations for a potential new blockbuster monoclonal antibody that treats high cholesterol.
India’s biomanufacturing sector has immense potential, but policy, infrastructure and finance-related issues are holding it back, say both Biocon and analysts.
Kemwell says it intends to open the Indian market to contract biomanufacturing as it signs its first monoclonal antibody (mAb) development and manufacture agreement for a European biopharma.
The $165bn biopharma market is expected to grow by about 15% annually, driven largely by increasing revenue growth from recombinant monoclonal antibodies (mAbs), according to a recent report.
Baxter and Coherus Biosciences have become the latest firms to try and develop a biosimilar version of the RA treatment Enbrel in a new collaboration announced this week.
Alexion Pharma International has recalled a single lot of its monoclonal antibody (MAb) orphan drug Soliris due to the presence of visible particles in a limited number of vials.
