The EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion and recommended granting a marketing authorisation to Boehringer Ingelheim and Eli Lilly’s biosimilar insulin treatment for Type 1 and Type 2 diabetes patients.
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.
Lonza has invested in single-use technology at its Swiss clinical manufacturing facility citing a rise in demand as customer’s grow their antibody-drug conjugate (ADC) pipelines.
Oncology development company Celsion will acquire Egen, a biotech company that is developing nucleic acid-based therapeutics, for $14m upfront, with the chance for more than $30m in milestone payments.
The World Health Assembly (WHA) has called on governments and regulators to improve public access to affordable biosimilars, saying the price of medicines can be ‘catastrophic.’
Thermo Fisher Scientific has licensed rights to gene editing technology for bioproduction applications that it claims targets DNA more precisely and reliably than current approaches.
European Provenge contractor PharmaCell BV is looking for new business after completing the acquisition of TiGenix’s biomanufacturing facility in the Netherlands.
Biomanufacturing in India is being held back by a lack of skilled workers but training initiatives are helping to address the problem, say Oncobiologics and Biocon.
US states continue to form disparate views of how to deal with biosimilars as Delaware Governor Jack Markell (D) signed into law last week a bill that would require pharmacists to notify prescribers if a biosimilar is substituted for a biologic.
BioAtla has received a broad patent covering conditionally active biologics (CABs) and says this antibody platform could shake up the development of this new class of therapeutics.
Michigan is the latest state to see a biosimilars bill come before its legislature as states pre-emptively grapple with how to deal with an expected influx of biosimilars.
A collaboration involving academia and industry is to develop new ways of delivering antibodies to the brain using molecular envelop technology developed by Nanomerics, a UCL spin-out company.
A government funded bioprocessing institute is helping to drive biopharma investment and retrain workers in Ireland, and Biopharma-Reporter.com visited to find out what happens in this "flight simulator for biopharma manufacturing."
Ambrx says it will use its antibody platform in its collaboration with Zhejiang Hisun Pharmaceutical Company to develop and commercialise bispecifics for the treatment of cancer.
Horizon, which supplies genomics research services, has bought cell-screening business CombinatoRx from Zalicus for £4.74m ($8m) and plans more acquisitions.
Novasep has made a $5.5m (€4m) investment to expand its highly potent active pharmaceutical ingredients (HPAPI) manufacturing capabilities at its Le Mans facility in France.
DISPATCHES FROM THE BIOLOGICAL PRODUCTION FORUM, DUBLIN
Single-use technology for high volume biomanufacturing is riddled with problems and will only be fully implemented by industry once the cost drops, according to Pfizer.
The FDA has finally released its biosimilar draft guidance for industry, which details how it will evaluate comparative analytical characterization of the biosimilar in relation to the reference product.
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
Hospira has predicted its biosimilar Retacrit will be approved by the US FDA from late 2016, making it among the first wave of biosimilars to be sold in the US.
GE Healthcare Life Sciences has signed a licensing agreement for Promosome’s suite of mammalian cell line development technologies, which aim to increase protein expression in mammalian cell culture.
Increased demand for mammalian technologies will boost Lonza further when a new Swiss facility comes online offering “unique” complete development and manufacturing ADC services, the firm says.
SAFC (Sigma-Aldrich Corporation) says it will invest across its life science businesses following a first quarter that saw “weak” contract manufacturing but flourishing viral and cell media sectors.
The latest generation of “biobetters” which are engineered to be more effective than branded biologics are hitting the market before biosimilars and could make development of the latter pointless, an expert has said.
As the race to develop mAbs (monocolonal antibodies) heats up and companies vie for the elusive seven years exclusivity that comes with an orphan drug designation, the US FDA is now offering guidance on when two mAbs should be viewed as the same.
The US biosimilars market is becoming complicated even before the US FDA has issued manufacturers with clear guidance, thanks to a rapidly evolving patchwork of varying State substitution laws.
Catalent will provide Hisun Pharmaceuticals with cell lines to help it develop infliximab, adalimumab and alemtuzumab biosimilars for the Chinese market.
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.
Recent investments in antibody-drug conjugate (ADC) technology will translate into more products on the market, but it will take time says Polytherics who has extended its licensing deal with MacroGenics.
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.
As Celltrion anticipates applying for US FDA approval for its Remsima biosimilar in the first half of 2014, the company this week filed suit in US District Court in Massachusetts against Janssen seeking to invalidate patents that would stop such a launch.
Baxter has announced plans to buy gene therapy developer Chatham Therapeutics for $70m in a deal focused on the latter’s pipeline of haemophilia candidates and gene therapy delivery platform.
IFPMA will advocate for all biologics to have a qualifier added to their names at the WHO’s INN Consultation on April 8, the biologics giant Amgen has told BioPharma-Reporter.com.
Aspyrian Therapeutics has teamed up with Goodwin Biotech to make antibody-drug conjugates (ADCs) with a technology platform that uses near‐infrared (NIR) light to activate the cytotoxin.
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.
Catalent has increased its stake in Redwood Biosciences telling us it is committed to the development of antibody-drug conjugates (ADCs) and the SMARTag technology platform.
Government-backing for a large-scale cell therapy centre is justified because it will help developers navigate the “valley of death” in which many early-phase projects fail says the team planning the new manufacturing hub.
