Novartis subsidiary, Sandoz, has secured a postive option from an EMA commitee in relation to its high concentration and citrate-free adalimumab biosimilar
A study has demonstrated the effectiveness and safety of adalimumab biosimilars Hulio and Hyrimoz in the therapy of patients with inflammatory bowel disease (IBD).
Sandoz said the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for a natalizumab biosimilar, developed by Polpharma Biologics.
The US FDA has accepted a supplemental biologics license application (sBLA) from Sandoz for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar, Hyrimoz.
Polpharma Biologics’ Marketing Authorization Application for natalizumab – a proposed biosimilar to Biogen’s Tysabri – has been accepted by the European Medicines Agency (EMA).
Sandoz has submitted its Biologics License Application (BLA) for a proposed biosimilar trastuzumab developed by EirGenix, Inc to the US Food and Drug Administration (FDA).
Biosimilar producer, Sandoz, has entered into a commercialization agreement for biosimilar, BAT1706, referencing Avastin (bevacizumab) with Bio-Thera Solutions for the treatment of multiple types of cancers.
Novartis subsidiary, Sandoz, says the US Supreme Court has denied its petition to review the Federal Circuit’s decision last summer in relation to Erelzi, its biosimilar of the Amgen reference medicine, Enbrel (etanercept), which is used to treat autoimmune...
The US District Court for the District of New Jersey ruled in Amgen’s favor on the validity of the two patents on Enbrel and the methods for making it.
The US market for insulin biosimilars is set to open up in 2020, and the head of biopharmaceuticals at Sandoz explained why he is confident of an ‘acceleration’ of the US biosimilar market in the coming years.
At least 80% of patients currently taking AbbVie’s blockbuster drug could be switched to “the best value biological medicine” within 12 months, according to the UK National Health Service.
After the business was asked by the US FDA to provide more data to secure an approval for its biosimilar, Sandoz decided not to pursue its regulatory filing any further.
Just days after the release of its Biosimilar Action Plan to encourage generic competition, the US FDA has approved another biosimilar product: Pfizer’s answer to Amgen’s Neupogen, ‘Nivestym’.
Major pharmaceutical firms Novartis, Roche, and Pfizer have reacted to the US FDA’s Biosimilar Action Plan, which aims to “strike a balance” between innovation and market competition.
