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The US FDA has issued draft guidance to help the biopharmaceutical industry assemble information and present data to support its analytical methodologies.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.
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.
Big Pharma takeovers of small biopharmaceutical companies to refill pipelines increased the volume and value of dealmaking in Q4 according to a new report by PwC.
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.
The US Food and Drug Administration (FDA) has issued Amgen with a Warning Letter at its Thousand Oaks, California plant citing violations in the production of monoclonal antibody combination products.
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.
Ski cheats planning to use human growth hormone (HGH) at the Winter Olympics may want to think twice as WADA expects a test for the biopharmaceutical to be available again soon.
AbbVie has invested $320m (€432m) into its first Asian manufacturing facility and says it will support an emerging antibody-drug conjugate (ADC) pipeline.
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.
Shipments of chicken pox vaccines from a troubled Belgian facility should recommence in early Q2 2014, says GSK, though the root cause of the manufacturing issues are still unknown.
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.
PharmaCell, the CMO that makes Provenge for Dendreon in Europe, has agreed to buy a facility from TiGenix to add capacity and a manufacturing contract for a second commercial product.
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.
Royal DSM has confirmed that its biologics manufacturing operations and new Australian facility will be part of the business merged with Patheon in its agreement with JLL.
WuXi PharmaTech has predicted that demand for its biopharmaceutical manufacturing services will increase this year just days after upping its guidance for fiscal 2013.
The US regulatory scientists who oversee biopharmaceuticals appear to be getting the funding they asked for after politicians pass a $1.2tr (€882bn) Government spending plan for fiscal 2014.
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...
Brad Pitt made himself sick to avoid a zombie virus in World War Z but, despite some real world precedents, he was lucky his gamble paid off according to virus experts we asked.
Good news for stem cell scientists this week with new data indicating that patients support the use of induced pluripotent stem cells (iPSC) in biopharmaceutical research if proper consent is obtained.
The climate for biomanufacturing has changed according to Pfizer, which has set out to win more contracting work for its hormone plant in Sweden and says it will even consider making large molecule drugs for Big Pharma rivals.
Choosing the same biomanufacturing tech supplier for development and commercial systems cuts scale steps and reduces lead times according to Cobra Biologics.
Researchers recently genetically engineered rice to produce high yields of an antibody that proved effective in a study to treat and prevent rotavirus-induced gastrointestinal symptoms in mice.
The European Commission (EC) has cleared Thermo Fisher’s acquisition of Life Technologies subject to certain divestitures including its media and sera for cell culture business.
Kadcyla has become the second antibody-drug conjugate (ADC) to be available in Europe, triggering a $5m milestone payment by Roche to technology partner Immunogen.
Parexel has seen small and mid-sized biopharma demand for development services decline in recent months according to an anaylst who attended the CROs presentation at the Jefferies Global Healthcare conference this week.
Biosimilar clinical trials are increasing but levels of physician oversight and regulatory decisions are still hurdles to overcome, say Parexel, PPD and Vince & Associates.
Unclear terms in US biosimilars laws and the high cost of filing with the Food and Drug Administration (FDA) has set the stage for legal battles according to a lawyer who spoke at AAPS this week.
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.
