As the fight over naming biosimilars continues in the US, the WHO has drafted its own system of biological qualifiers to ensure biosimilars remain unique from their biologic counterparts.
Scientists from USP (US Pharmacopoeia), Apotex and an advisory board established by Amgen are all weighing in with suggestions and points of further clarity on the latest US FDA draft guidance on biosimilars.
The European Medicines Agency (EMA) has released a second module of a new guideline on influenza vaccines for a six-month public consultation, which covers the non-clinical and clinical requirements for the development of new flu vaccines.
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.
Amgen says it will continue to invest in manufacturing technologies to support its biosimilar pipeline despite announcing a restructuring that will reduce its manufacturing footprint by 23%.
Bristol-Myers Squibb and Ono Pharmaceuticals have expanded their collaboration to jointly develop and commercialise the monoclonal antibody drugs Opdivo and Yervoy.
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.
UK industry groups have rejected the idea their call for doctors to use brand names rather than INNs in new biosimilars FAQ documents is about protecting member firms’ market share.
Biosimilars are not analogous to small molecule generics in terms of market share loss according to Johnson & Johnson, which is confident its biopharmaceutical portfolio can withstand competition.
The acquisition of Shire for £31bn ($53bn) has moved a step closer but reliance on third party suppliers would only add two facilities to AbbVie's biomanufacturing network.
Regulations governing the production of vaccines in China have been praised by WHO director general Margaret Chan following an assessment of the CFDA's oversight of the sector conducted last October.
While the overall bioscience industry has seen 7.4% jobs growth between 2001 and 2012, the sector encompassing CROs and other research, testing and medical labs has grown by more than 28%, according to a new report from industry group BIO and Battelle.
The draft guidance aims to provide sponsors of virus or bacteria-based gene therapy products (VBGT products) and oncolytic viruses or bacteria (oncolytic products) with recommendations on how to conduct shedding studies during preclinical and clinical...
Ono Pharmaceuticals has received approval for Opidvo (Nivolumab) in Japan becoming the first biopharma to bring a fully human PD-1 monoclonal antibody to market.
The fight over how biosimilars should be named in the US just got more tense as a group of pharmacists, pension systems and the Generic Pharmaceutical Association are calling for a system similar to what’s used in the EU, with the same INNs (international...
Biopharma firms continued to attract US venture capital investment in Q1 according to new analysis by PricewaterhouseCoopers (PwC), which says the number of firms that received backing is encouraging.
The European Medicines Agency’s Committee for Advanced Therapies (CAT) has revised a reflection paper on the classification of advanced-therapy medicinal products (ATMPs) to reflect cases in which medicines can be classified as ATMPs.
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.
European biopharmas trying to avoid “death valley” went to California this week according to industry groups, investors and officials who met in Belgium this week to discuss ways of making it easier for companies to access funding on this side of the...
GSK is confident it can meet Flulaval production targets ahead of this winter’s flu season despite ongoing endotoxin contamination problems at a Canadian plant hit with US FDA warning letter.
As biopharma companies look to take advantage of a biosimilar market set to exceed $3.7bn by 2016, experts say the different regulations governing the follow-on biologics may be an issue as the markets become more developed.
Alexion says it has provided NICE with the R&D and manufacturing information it asked for ahead of the second assessment of its £3,150-a-vial rare blood disorder drug Soliris next month.
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.
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.’
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.
Alexion has recalled another nine lots of Soliris after finding "visible particles" in vials of the $600,000-a-year drug for the third time in 10 months.
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.
BioPharma-Reporter.com recently spoke with contract testing supplier BioOutsource to see what its take is on biosimilars now that the FDA’s draft guidance on biosimilarity has been released. The following is a lightly edited interview with BioOutsource’s...
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.
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.
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.
No shortage of an FDA approved scorpion anti-venom biopharmaceutical is envisioned after a manufacturing facility in Mexico received a Warning Letter, US distributor Rare Disease Therapeutics says.
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 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.
