Hemispherx has installed a 600 litre bioreactor at its manufacturing facility in New Jersey and plans to seek approval to restart production of its alpha interferon product, Alferon N Injection.
The US FDA has delayed an advisory committee review of Celltrion's Remicade (infliximab) biosimilar after asking the South Korean drugmaker for more information.
Apotex’s Neupogen (filgrastim) copycat Grastofil could be on US pharmacy shelves as early as December, after the US Food and Drug Administration (FDA) started its review this week.
The EMA has defended its decision to redact three Humira clinical study reports, arguing that the information held back was ‘commercially confidential.’
Sandoz’s recommendation was an “inevitable step” in the introduction of biosimilars to the US, and the US FDA should expect more submissions according to a consultant.
Manufacturing issues surrounding low protein content in batches of Sandoz’ Neupogen copycat have been resolved ahead of an FDA review which could herald the first US biosimilar.
Reference drugs in biosimilar trials now only need to be “representative” of a product cleared in the EEA not approved themselves under guidelines issued by the EMA this week.
A new list of biopharmaceuticals published by the US FDA provides limited information with only the entries for Neupogen, Perjecta and Granix including expiry dates.
As the US FDA (Food and Drug Administration)’s biosimilars pathway is tested for the first known time following Sandoz’s filgrastim submission last week, an expert predicts imminent biosimilars submissions from Celltrion and Hospira.
Mailroom and legal staff at Sandoz and Amgen are in for a busy six months after the US FDA agreed to review a biosimilar version of the anti-infective, Neupogen.
US demand for biosimilars testing will grow substantially in the next few years according to BioOutsource, which expects to generate half of its revenue in the country by 2019.
Formulations that stop biopharmaceuticals being degraded by vials and syringes could help biopharmas avoid recalls and improve product shelf life says the UK team behind an industry focused research collaboration.
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.
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.
The biotechnology and pharmaceutical bodies AusBiotech and Medicines Australia have asked the Australian Minister for Industry to invest in biopharma R&D and secure patents.
Live insects observed during filling operations at a Greer Laboratories facility were one of a number of violations in the manufacture of its biological allergenic extracts cited in a US FDA warning letter.
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.
The US Food and Drug Administration (FDA) has approved a second “Breakthrough Therapy” biologic but it is still unclear whether the programme speeds drugs to market, says an expert.
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.
The US agency that oversees biopharmaceuticals will continue to assess lot release samples for approved productions but BLA review timelines may be impacted by its move to a new HQ in Maryland.
Big Biopharma has backed passage of Indiana substitution laws that require doctors to grant pharmacists permission to switch a biologic for a biosimilar.
The US FDA has issued draft guidance to help the biopharmaceutical industry assemble information and present data to support its analytical methodologies.
As US FDA Commissioner Margaret Hamburg finishes her trip through India, the country is now shifting its focus to the regulation of stem cell and other cell therapies.
CMO Cytovance Biologics has entered into a manufacturing agreement with Pamlico Biopharma to develop a group of three human IgG monoclonal antibodies intended for the treatment of Streptococcus pneumoniae infections.
Industry group BIO has responded to a petition by the Generic Pharmaceutical Association (GPhA) in the latest bout of the debate over the international non-proprietary name (INN) for biosimilars.
Biosimilars could save the US healthcare budget a quarter of a trillion dollars, says Hospira who expects to submit its first application to the USFDA within a year.
Johnson & Johnson (J&J) has called on the US FDA to prevent biosimilars being given the same non-proprietary names as their original biologics, while the European Generics Association maintains the practice is “proven to be safe” and “supported...
Biosimilar clinical trials are increasing but levels of physician oversight and regulatory decisions are still hurdles to overcome, say Parexel, PPD and Vince & Associates.
Novartis has joined the debate regarding the international nonproprietary names (INNs) of biologics saying some companies are casting unnecessary doubt on biosimilars under a guise of pharmacovigilance.
Gilead will spend $47m (Eur 34m) to expand a Canadian plant at which it produces biopharmaceuticals for trials, including its Ph III hep C drug candidate sofosbuvir.
“Reports of my death have been greatly exaggerated” said American author Mark Twain, and yesterday Janet Woodcock - another American author, albeit of a number of US drug initiatives - echoed his words denying rumours of her imminent retirement.
As California approves a Bill constraining biosimilar substitution, the US FDA says it is concerned at efforts to undermine strict federal legislation already in place.
A third Novartis biopharmaceutical has received breakthrough designation status from the FDA allowing ‘fast-track’ development and review without compromising safety, the company says.
A trend to outsource storage solutions is being driven by a need to cut costs, says Vindon, though uptake amongst biomanufacturers trails that of small molecule manufacturers.
In a momentous first for both countries, regulatory officials from China and Taiwan sat down at the same table on Tuesday and discussed their relatively similar ideas around the regulation of drug approvals.
Biosimilar developers such as Mylan and Pfizer are taking issue with FDA draft guidance that in some circumstances could extend biosimilar development timelines and discourage their development.
Goodwin Biotechnology has teamed up with Coldstream Laboratories to offer clients ADC services as another example of biopharma demand driving contract manufacturing and development.
West Pharmaceuticals says it is still intent on shifting to proprietary products following results from its packaging and contract manufacturing businesses.
The US FDA has finally adopted the revised ICH Q11 guidelines on drug substance manufacturing nearly six months after European regulators embraced the guidelines.
