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recently spoke with contract testing supplier BioOutsource to see what its take is on biosimilars now that the FDA’s draft guidance on biosimilarity has been released.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The FDA has finally released its biosimilar draft guidance for industry, which details how it will evaluate comparative analytical characterization of the biosimilar in relation to the reference product.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.
Cell therapy developer NeoStem has agreed to acquire California Stem Cell in a deal worth up to $124M, and includes CSC’s manufacturing facility in Irvine, CA.
The US agency that oversees biologics approved eight vaccines for diseases ranging from influenza to Japanese encephalitis in 2013 according to a new report.
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.
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.
Despite the director’s resignation, the US NIH Intramural Center for Regenerative Medicine (CRM) has not closed and will hold a workshop to guide the direction of the center’s future, the NIH told us.
Revising the regulations that govern gene and cell therapies - known as advanced therapy medicinal products (ATMPs) - will increase the number of marketing authorisation applications for such products and attract more Big Pharma involvement according...
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.
In direct opposition to a petition raised by GPhA (Generic Pharmaceutical Association) and Novartis, AbbVie, Genentech and Amgen are all looking for the US FDA to call for new non-proprietary names for biosimilars.
GSK’s Eperzan (albiglutide) has become the first approved drug to use the Veltis half-life extension technology and, according to Novozymes, may make it a strong competitor in the GLP-1 agonist market.
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.
Industry group BIO has commended Indiana Governor Mike Pence for signing laws that will mean doctors must give pharmacists permission to switch a biologic for a biosimilar.
Government-backing for a large-scale cell therapy centre is justified because it will help developers navigate the “valley of death” in which many early-phase projects fail says the team planning the new manufacturing hub.
When Frank Sinatra sang "If you can make it there, you can make it anywhere" in New York, New York he probably wasn't talking about biopharmaceutical production.
The US FDA says that it “becomes concerned” when excess volume in an injectable vial is greater or less than what the US Pharmacopeia (USP) recommends without proper justification, according to new draft guidance.
An analyst predicts overlap between Thermo Fisher and Life Technologies will present manufacturing, procurement and logistics cost-saving opportunities.
Ireland is seeing a renewed interest from biotech, the Industrial Development Agency (IDA) says, as Bristol-Myers Squibbs shuts a Dublin API plant to focus on biopharmaceuticals.
The EMA and US FDA say the chimeric nature of antibody drug conjugates (ADC) does not make them any harder to regulate and that existing guidelines for small and large molecule drugs are sufficient.
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.
Operations will continue and may even be enhanced at DSM’s Australian taxpayer-funded biologics plant following a merger with Patheon, the Queensland Government says.
The high street of tomorrow is likely to be a mix of supermarkets, banks and biopharmaceutical manufacturing plants according to one expert who says urban drug production has significant advantages for Pharma firms and patients.
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.
Seattle Genetics has been upgraded to ‘outperform’ by an analyst based on its antibody-drug conjugate (ADC) technology platforms, pipeline and the potential of Adcetris to become a blockbuster.
Antibody-drug conjugates (ADCs) are fully covered by current regulations, the EMA says, though a surge of applications is not expected in the light of Roche’s recent success.
The US FDA has issued draft guidance to help the biopharmaceutical industry assemble information and present data to support its analytical methodologies.
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.
