English pharmacists are not free to dispense biosimilars in place of reference biologics, the country’s National Health Service says in its latest guidance.
Regeneron Pharmaceuticals will use it speedy mAb development tech to move an Ebola drug into clinical trials under a $38m (€34m) US Government contract.
Sandoz has reiterated its call for US FDA guidance on biosimilar interchangeability arguing that the lack of clarity makes it hard to gauge what impact switching rules will have on pricing.
FDA’s Janet Woodcook has defended delays in producing biosimilar interchangeability and labelling guidances, saying the scientific framework must first be ‘bulletproof.’
A copycat version of Amgen’s Enbrel has been approved in Korea, marking the first regulatory success for Merck & Co and Samsung Bioepis' biosimilar joint venture.
Sanofi’s decision to stop manufacturing an anti-venom will contribute to “needless death and disability” for snake bite victims, according to Médecins Sans Frontières.
Review of Alexion’s enzyme replacement therapy Kanuma (sebelipase alfa) has been pushed back after the US FDA requested more Chemistry, Manufacturing and Controls (CMC) information.
Sandoz has joined biosimilar developers calling on the US FDA to provide clear guidance on interchangability just a day after launching Zarxio, its Neupogen (filgrastim) copycat.
Pfizer’s planned divestiture of its infliximab biosimilar candidate could create a race among competitors to gain access to the product, but in the early going, no clear leader has emerged.
Army training is ideal preparation for a biopharma career according to the US National Center for Therapeutics Manufacturing, which is seeking former military personnel interested in learning about bioprocessing.
The US FDA has published long-awaited guidelines on the non-proprietary naming of biological products, but biosimilar makers say adding a random four-letter suffix could needlessly complicate the prescribing system.
A study commissioned and funded by reference biologic maker AbbVie has found biosimilars will have a smaller cost-saving impact on the US market than previously believed, especially for employers in the commercial and retiree marketplace.
The UK’s Biomedical Catalyst funding scheme encourages investors to back innovative biopharma research and should be continued according to the BioIndustry Association (BIA).
Hemispherx Biopharma has signed extended US distribution agreements as part of efforts to relaunch Alferon N Injection, a genital wart treatment it pulled in 2008 after production costs soared.
A surge in UK cell therapy production last year means available manufacturing capacity has declined considerably according to a report by Cell Therapy Catapult.
Contract manufacturer Emergent BioSolutions and biosimilar developer Pfenex have both announced in recent days that they’ve won contract manufacturing and development grants with the US government.
A leaked draft of Trans-Pacific Partnership negotiations reveals US plans to massively broaden IP for biologics and opens the door to monopolies, says MSF.
A group of House leaders are taking issue with the way CMS (Centers for Medicare & Medicaid Services) has laid out plans to reimburse for biosimilars, according to a letter 30 members of Congress sent to CMS’ acting administrator last week.
US politicians have given the NIH and FDA until Friday to answer questions about oversight at a contaminated National Institutes of Health clinical trial manufacturing site.
The European Commission has approved Pfizer’s acquisition of Hospira, providing the larger company first divests of its infliximab candidate and several sterile injectables.
Remicade biosimilars have had no meaningful impact on AbbVie’s parallel TNF inhibitor Humira, management says, despite international Q2 sales of the mAb being down 14% year-on-year.
A surge of demand in biologics contract testing and biosimilar characterization has caused BioOutsource to double its capacity with the opening of a new facility in Glasgow, Scotland.
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.
Lonza has reported higher revenues and profits for H1 2015, but warned that the strength of the Swiss franc means its Visp facility is still finding it hard to compete.
Novartis’ Sandoz unit will begin selling a biosimilar for Amgen’s cancer treatment Neupogen on September 2, thanks to an appeals court ruling released Tuesday.
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.
A Medicare reimbursement policy proposing that biosimilars have the same pricing code as their reference products could ultimately reduce R&D investment, according to an industry group.
A new final rule from the US FDA now requires all drug and biologic manufacturers to notify the agency electronically of a permanent discontinuance or an interruption in manufacturing six months in advance, or as soon as is practical, before the disruption...
As biopharmaceutical companies look to cut costs and understand their core competencies further, the use of outsourcing and off-shoring have become even more mainstream than in years past, according to the 12th annual biomanufacturing report from BioPlan...
