The proof-of-concept trial, dubbed IRIS-RA, is the first to investigate a treatment for rheumatoid arthritis that blocks a protein called neonatal Fc receptor (FcRn).
The antibody drug nipocalimab, developed by the Janssen Pharmaceutical...
The patent for Janssen’s second-generation, tumour necrosis factor-alpha (TNF)-a inhibitor Simponi (golimumab), is scheduled to expire in 2024 and in 2025 in the US and EU, respectively.
Biogen Inc and Xbrane Biopharma AB have entered into a commercialization and licensing agreement on Xcimzane, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA.
Novartis subsidiary, Sandoz, says the US Supreme Court has denied its petition to review the Federal Circuit’s decision last summer in relation to Erelzi, its biosimilar of the Amgen reference medicine, Enbrel (etanercept), which is used to treat autoimmune...
Scotland’s University of Glasgow has entered into a research collaboration with pharma group, Eli Lilly, to develop the next generation of drug targets for immunological diseases.
Therapies for cancer, autoimmune diseases, inflammatory diseases and other drug markets are all siloed, despite new research emerging that shows potential connections between them. In order to create more effective therapeutics, we need to pull from research...
The US FDA has approved Genentech’s auto-injector formulation of Actemra, which the firm says offers an additional administration option for patients and caregivers.
The US FDA has rejected Janssen Biotech’s application for sirukumab, a monoclonal antibody (mAb) designed to treat severely active rheumatoid arthritis (RA).
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.
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.
Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.
Biosimilar developers have welcomed a court ruling against AbbVie regarding Humira indication patents, but an IP lawyer warns the judgement is not binding outside the UK.
The US FDA has issued a complete response letter for Sanofi and Regeneron’s rheumatoid arthritis candidate sarilumab due to manufacturing deficiencies at a fill/finish plant in France.
Amid ongoing patent litigation, the FDA has approved Amgen’s Amjevita: the first US biosimilar version of AbbVie’s top selling rheumatoid arthritis biologic Humira.
Biosimilars will capture new patients in the first instance while existing patients will gradually switch over says Pfizer, a developer of both originator biologics and copycats.
Mundipharma has begun the latest phase of its Remsima promotion campaign, unveiling two-year data indicating the infliximab biosimilar is as safe and effective as the originator.
Approving a biosimilar for the same diseases as the originator drug based on extrapolated data rather than study results should remain a cornerstone of the review process say regulators and developers.
As competition begins to erode worldwide sales and litigation challenges Humira’s dominance, AbbVie says it will “prevail” with its new biosimilar strategy.
MedImmune has the option to acquire a Chinese biologics manufacturing facility for around $100m in an expansion of its joint venture with WuXi Apptech.
Remsima will soon achieve total market dominance in Norway thanks to a 69% discount on J&J’s Remicade, the man behind a trial studying the impact of biosimilar switching says.
With Pfizer closing in on Hospira and Sandoz set to launch Zarxio in the US, it’s been a defining week for biosimilars, our BioFinance Vision feature explains.
Sales of Jonson & Johnson’s Remicade have been hit by biosimilar competition but the firm remains confident it will maintain leadership in the immunology space.
Celltrion’s Remsima campaign rolled into the US this week with another presentation of data showing that the Remicade (Infliximab) biosimilar is equivalent to the reference drug.
US rheumatoid arthritis (RA) sufferers will still face high drug prices after biosimilar are available unless insurers reclassify such meds according to the author of research on biologic DMARD costs.
Hospira, recently acquired by Pfizer, announced Monday the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets, following the patent expiry of J&J’s Remicade.
The first rival to AbbVie’s mega-blockbuster arthritis treatment Humira has hit the shelves in India, with Zydus Cadila claiming its launch began on Tuesday.
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.
The biosimilar market is expected to ramp up in Asia and Europe, even as it’s yet to be initiated in the US, with AbbVie, Amgen and Roche’s blockbuster biologics the most threatened, Moody's Investors Service says in a new report.
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.
Ablynx and Merck Serono expanded their relationship for a fourth time – this time in a four-year deal worth about $34m (€25m), including an initial payment of $15.5m (€11.5m).
New auto-injector technology that is user-friendly and capable of delivering high viscosity drugs may be the next big thing for pharma and biotech companies pushing further into niche biologics and biosimilars.
Bristol Myers-Squibb says its $250m (€191m) expansion of its US biologics facility will centralize its processes and become a springboard to launch new products.
Roche has committed hundreds of millions of dollars to an
early-phase rheumatoid arthritis drug, a move that is indicative of
big pharma's increasing tendency to license earlier phase
compounds.
