The EBG (European Biosimilars Group), a part of the EGA (European Generic Medicines Association), says that more complex systems for naming biosimilars increases the likelihood that physicians and pharmacists will leave something out and disrupt the tracking...
An Ebola viral vector vaccine in development by Profectus BioSciences works in monkeys against the virus strain currently infecting humans in West Africa.
Pfizer’s termination of a partnership to develop Factor VIIa products may have implications in the recently announced merger of Catalyst Biosciences with Targacept.
The Medicines Evaluation Board (MEB) of the Netherlands has updated its position about biosimilars, saying the relatively new products “have been proven to have no relevant differences compared to an innovator biological medicinal product as far as quality,...
Bristol-Myers Squibb will use uniQure’s insect-cell based technology and manufacturing facilities to develop gene therapies for cardiovascular diseases in a deal potentially worth $2bn (€1.8bn).
Juno Therapeutics has agreed to settle litigation with Novartis and the Trustees of the University of Pennsylvania after Juno entered into a December 2013 license agreement with St. Jude Children’s Research Hospital, which owned the patent rights.
Data must drive US FDA efforts to determine biosimilar interchangeability according to a Pfizer exec who told Goldman Sachs conference delegates not to expect a definition anytime soon.
With the release of four different documents around the pricing and use of biosimilars this week, the US CMS (Centers for Medicare and Medicaid Services) is making clear it will fully encourage states to call on prescribers to use cost-effective biosimilars...
A Georgia bill, which passed both the state House and Senate last week, calls for new language on biosimilar labels that say that the product is “interchangeable.”
Biosimilar firms seeking US approval will not have to commit to share manufacturing data with reference drug firms before reviews, after the FDA rejected Amgen’s request for such a rule.
A district court judge from California has denied an injunction by Amgen meant to stop the launch of the first biosimilar approved by the US FDA – Sandoz’s Zarxio (filgrastim-sndz).
Athersys and Chugai Pharmaceutical have announced a partnership and license agreement to exclusively develop and commercialize MultiStem cell therapy for ischemic stroke in Japan.
A doctor whose thumb was punctured by a needle while working with Ebola patients in Sierra Leone received Merck & Co.’s vaccine candidate and did not develop the virus.
More than a year since California saw its previous biosimilar substitution bill vetoed by its governor and more than two years since Illinois tried its hand, both are again looking to become the ninth and tenth states to see new substitution laws.
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.
Celltrion has emphasised the savings Remsima ((inflizimab) could offer at a conference in Spain as partner Napp Pharmaceuticals prepares to extend the roll out of the Remicade biosimilar to the UK.
Novasep has signed a €4.7m ($5.4m) agreement with Celladon, a clinical-stage biotechnology company, to prepare to supply the drug substance for the heart failure treatment Mydicar.
Hospira, recently acquired by Pfizer, announced Monday the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets, following the patent expiry of J&J’s Remicade.
The US FDA has set a date to review its first monoclonal antibody (mAb) biosimilar: a version of J&J’s Remicade marketed by Pfizer takeover target Hospira.
Fresh of its acquisition of Novartis’ vaccine business, GlaxoSmithKline is doubling down with the purchase of GlycoVaxyn AG, a Swiss-based specialist vaccine maker, for $190m (£124m).
Big biotech firms risk the empty pipeline pitfalls of old pharma if they protect their drugs from biosimilars rather than invest in innovation, ex-Teva CEO Jeremy Levin warns.
update: WHO says tech like Nanopatch can help get vaccines to the people that need them
Amgen has benefited from enhanced regulatory discussions surrounding biosimilars, the firm says, as it develops a pipeline of nine products alongside its own biologics.
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.
Australia’s TGA (Therapeutic Goods Administration) is shifting its stance on the way it plans to name biosimilars to keep the country more in line with the WHO’s (World Health Organization) proposed policies.
President Obama in his State of the Union address has called for the power to personally make stronger trade agreements – bringing divisive EU deal TTIP closer to adoption and angering campaigners for drugs access.
So far most biosimilars filed in the US have been ‘low risk’ according to contractor BioOutsource, which warned that developers seeking approval for copycat mAbs face higher legal and regulatory hurdles than in Europe.
India-based CMO Piramal has acquired US-based sterile injectable CDMO (contract development and manufacturing organization) Coldstream Laboratories for $30.65m.
