Amgen is launching Amjevita, or adalimumab-atto, a biosimilar to AbbVie’s Humira, in the US; it is the first such biosimilar to the blockbuster drug in that market.
Last year was a slow one in terms of dealmaking in the life sciences sector but the final quarter saw a major uptick, finds the EY annual M&A Firepower report.
AstraZeneca and Amgen’s Tezspire (tezepelumab-ekko) has been approved in the US for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
A US court’s recent decision to find in favor of Sanofi and invalidate Amgen's broad antibody patent claims has biotech manufacturers concerned about how to preserve their IP.
Four pharma companies are providing half of the investment required for ‘world’s largest genetics project’, in return for access to the genomic data generated.
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.
Amgen’s biosimilars portfolio reaches a milestone after its Herceptin biosimilar, Kanjinti, developed in collaboration with Allergan, was approved by the US FDA.
‘We don’t want to change the way we work,’ says GE Healthcare Life Sciences CEO, as Danaher’s $21bn acquisition of the BioPharma business continues in the background.
Amgen and Takeda will join fellow big pharma companies Sanofi, GSK, and Janssen, in working to progress Feldan’s intracellular drug delivery technology.
GE Healthcare partners for digital data exchange collaboration program with Amgen to advance understanding of biomanufacturing process on raw material variability.
Pfizer has launched the first biosimilar to J&J’s Procrit and Amgen’s Epogen in the US at a ‘significant discount’ to competitors’ wholesale acquisition costs.
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’.
AbbVie’s mega-blockbuster Humira is facing biosimilar competition, but another patent licensing agreement, this time with Mylan, sees the company securing exclusivity through to 2023 in the US.
The promised jobs were always part of Amgen’s 2017 plans says CEO Robert Bradway, but a reduced US footprint means hiring more biomanufacturing staff is unlikely.
Amgen will manufacture, trial and sell cancer immunotherapies developed in collaboration with Immatics Biotechnologies GmbH under an agreement announced this week.
Biosimilar makers have been vocal about product names not differentiating from their reference biologics, so why does the newly-approved Humira copy appear to reference its sponsor, Amgen?
Amid ongoing patent litigation, the FDA has approved Amgen’s Amjevita: the first US biosimilar version of AbbVie’s top selling rheumatoid arthritis biologic Humira.
US Enbrel biosimilar could be available as early as February 2017
Sandoz says gradual uptake of its biosimilar will eat away at Amgen’s filgastrim market share which stands at 76% four months after Zarxio’s entry in the US.
Novartis’ Sandoz unit will begin selling a biosimilar for Amgen’s cancer treatment Neupogen on September 2, thanks to an appeals court ruling released Tuesday.
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).
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.
Amgen has benefited from enhanced regulatory discussions surrounding biosimilars, the firm says, as it develops a pipeline of nine products alongside its own biologics.
Biopharma heavyweights Amgen, Pfizer and a number of other companies offered their unique takes on the biosimilar draft guidance from the EMA, calling for more clarity and some new additions before the final draft takes effect.
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.
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.
