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Berichten met het trefwoord ‘Humira’

Boehringer Ingelheim presents phase III results demonstrating clinical equivalence of biosimilar to Humira

Boehringer Ingelheim has announced results from the pivotal Phase III VOLTAIRE®-RA(1) study, confirming that its adalimumab biosimilar candidate BI 695501 and HUMIRA®* have similar efficacy, safety and immunogenicity in patients with moderately-to-severely active rheumatoid arthritis. The 24 week results will be presented at the Annual European Congress of Rheumatology (EULAR 2017) in Madrid.

Bron: World Pharma News Meer lezen »

Amgen wins European approval for Humira biosimilar Amgevita

The European Commission has approved Amgen’s biosimilar version of AbbVie’s $16.1bn-a-year autoimmune disease treatment Humira (adalimumab). Amgevita (biosimilar adalimumab) is both Amgen’s first biosimilar and now the first Humira biosimilar to be approved in Europe.

Bron: PMLiVE Meer lezen »

Phase 3 data for Janssen psoriasis drug shows efficacy over Humira

Janssen has revealed new Phase 3 data for its human monoclonal antibody guselkumab in the treatment of adults with moderate to severe plaque psoriasis, showing the drug to produce significant efficacy compared to Abbvie’s blockbuster drug and market leader Humira (adalimumab).  

Bron: Meer lezen »

Amgen drug pair become first Humira biosimilars to win EU approval

Good news for Amgen as its two biosimilar versions of AbbVie’s blockbuster rheumatoid arthritis (RA) drug Humira (adalimumab) have been awarded recommendation for approval by the European Medicines Agency (EMA) for the treatment of moderate to severe RA in patients who have not responded to methotrexate or have not been previously treated with it.

Bron: Meer lezen »

FDA panel backs Amgen copy of AbbVie arthritis drug Humira

 Amgen Inc’s cheaper version of AbbVie’s top-selling arthritis drug Humira is highly similar to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday.

Bron: Reuters Meer lezen »

Amgen’s Humira biosim ‘highly similar’ to AbbVie original, FDA staffers say

  Things look good for Amgen heading into a Tuesday advisory committee meeting on its Humira biosimilar candidate. In briefing documents released Friday, FDA staffers said that their review of data from rheumatoid arthritis and plaque psoriasis trials of the prospect–dubbed ABP 501–suggested Amgen’s copy was “highly similar” to Humira, an AbbVie drug that currently tops […]

Bron: FiercePharma Meer lezen »

European pharma ‘to grow 3.2% per year by 2022’

Forecast predicts AbbVie’s Humira will be knocked off the top spot.

Bron: PMLiVE Meer lezen »

Sanofi’s sarilumab beats Humira in head-to-head trial

Sanofi is celebrating new data from a comparative trial which showed its rheumatoid arthritis (RA) candidate sarilumab was more effective than AbbVie’s market-leading Humira.

Bron: PMLiVE Meer lezen »

U.S. patent office rules against Amgen Humira challenge

U.S. patent officials on Thursday denied petitions by Amgen to review two formulation patents on AbbVie’s Humira, a potential setback in Amgen efforts to market a biosimilar version of the world’s top-selling prescription medicine.

Bron: Reuters Meer lezen »

Humira gives AbbVie solid Q3 support, but biosimilars loom

Humira continued to bring in more than half of AbbVie’s revenues, exceeding analysts’ expectations and propelling the drugmaker to an earnings beat. But one of the company’s hopefuls, hep C med Viekira Pak, missed in Q3, potentially throwing a wrench into AbbVie’s plans to reap more from new meds.

Bron: FiercePharma Meer lezen »

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