Education is vital for biosimilar success in the US market, according to an industry advocacy group which is preparing to launch a programme for patients and healthcare providers.
The $2.4bn market for “unproven” and “unethical” biologics market “preys on vulnerable patients” and harms development of legitimate large molecule drugs, says the International Society for Cellular Therapy (ISCT).
Humira's extensive estate of over 70 formulation, manufacturing and method of treatment patents will keep US competition at bay until at least 2022, says AbbVie.
The biosimilars space is becoming more crowded as new players are attracted by reduced development costs and growing market confidence, according to a panel of experts.
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.
Eagerly awaited interchangeability guidance will be at odds with the US FDA’s recent guidance on naming biological products using a four-letter suffix according to a panel of biosimilar experts.
Want to pass an FDA inspection? Do not answer back, do not volunteer information and do not sign anything, says an ex-auditor and regulatory consultant.
M+W has been contracted to build a £55m ($84m) manufacturing site that will support cell and gene therapy developers by the UK Government project, Cell Therapy Catapult.
Biologic drugs will be given a minimum of five years of data protection under the TPP (Trans-Pacific Partnership) trade deal agreed today, upsetting industry groups which had campaigned for 12.
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.