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board established by Amgen are all weighing in with suggestions and points of further clarity on the latest US FDA draft guidance on biosimilars.
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%.
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.
With almost three decades of recombinant protein production experience, Novartis is now seeing its work paying off as its biosimilars grew by 23% over the same quarter last year to $420m (€310.5m) in Q2.
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...
The EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion and recommended granting a marketing authorisation to Boehringer Ingelheim and Eli Lilly’s biosimilar insulin treatment for Type 1 and Type 2 diabetes patients.
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.’
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.
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.
The FDA has finally released its biosimilar draft guidance for industry, which details how it will evaluate comparative analytical characterization of the biosimilar in relation to the reference product.
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 latest generation of “biobetters” which are engineered to be more effective than branded biologics are hitting the market before biosimilars and could make development of the latter pointless, an expert has said.
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.
Catalent will provide Hisun Pharmaceuticals with cell lines to help it develop infliximab, adalimumab and alemtuzumab biosimilars for the Chinese market.
The High Court in London has revoked two patents referring to the dosage and composition of Roche’s monoclonal antibody drug Herceptin, paving the way for Hospira’s biosimilar product.
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.
IFPMA will advocate for all biologics to have a qualifier added to their names at the WHO’s INN Consultation on April 8, the biologics giant Amgen has told BioPharma-Reporter.com.
Proposals in President Obama’s 2015 budget to reduce the market exclusivity period for biologics could save the US $4bn (€2.9bn) but have been labelled unproductive by industry groups.
Proteomics International has agreed to collaborate with inVentiv Health to develop biosimilars and biologics, which will begin with structural and functional characterization.
Big Biopharma has backed passage of Indiana substitution laws that require doctors to grant pharmacists permission to switch a biologic for a biosimilar.
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.
Most EU member states “strongly supported” the idea that biosimilars should be closely aligned with their reference products, according to a summary of the European Commission’s pharmaceutical committee meeting released Monday.
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.
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.
Mylan says it will continue to manufacture and sell its Indian version of trastuzumab despite an injunction by Roche restricting reference to it as a biosimilar of Herceptin.
BioOutsource says it has quadrupled its revenue from biologics testing and biosimilar characterisation in the last 18 months and is opening a new facility to cope with continued demand.
It is no clearer how the US will govern biosimilar naming, approval and substitution despite a day-long Federal Trade Commission (FTC) workshop that produced heated debate but few concrete answers.
Politics might not be the only obstacle in getting biosimilars approved in the US, though much of the rest of the world seems intent on obtaining approvals as fast as possible, according to a new report from research company Frost & Sullivan.
The end of Lonza’s biosimilar joint venture with Teva will not affect manufacturing capacity, the firm says, as it reports a drop in overall revenue for 2013.
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.
Biocon has defended criticism of the high price of its Trastuzumab biosimilar which will become the world's first copycat version of Roche’s Herceptin when launched next month.
Hospira says its biosimilar partnership with Celltrion is secure even if the South Korean manufacturer is acquired as several media reports have speculated.
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...
