Tag Archives: Humira

Patients lose, lawyers win, as AbbVie does deal with Amgen to delay Humira biosim.

The News: Amgen Inc. (Thousand Oaks CA) has agreed to delay the US launch of its FDA-approved biosimilar version of AbbVie Inc.’s (North Chicago) Humira (adalimumab) until 2023, under a… Read more »

Amgen, Allergan get nod for Avastin biosim; FDA’s Gottlieb making good on vow to hasten generic approvals, catch the EU.

The News: Amgen Inc. (Thousand Oaks CA) and Allergan PLC (Dublin IRL) said Thursday (September 14, 2017) that the Food and Drug Administration has approved their biosimilar version of Roche… Read more »

Alexion on a roll as Soliris gets label expansion in EU; although flying under the radar, analysts, investors still bullish.

The News: Alexion Pharmaceuticals Inc. (New Haven CT) got another shot in the arm this week with the EU approving its key revenue driver Soliris for an additional indication. EU approval… Read more »

Abbvie’s biosimilar fight over Humira patent highlights differences between EU and US regulatory mindsets

The News: Coherus BioSciences Inc. (Redwood City CA) last week announced that the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office ruled in the company’s… Read more »

Express Scripts says prescription drug spending slowed in 2016; but compared to what, a speeding train?

The News: According to a recent report released by Express Scripts Holding Co. (St. Louis MO), the average list price of the most commonly used branded drugs in the US… Read more »

Biotech predictions for 2017 return to positive fundamentals; 2016 meltdown still in rear-view mirror

The NASDAQ Biotech Index got hammered in 2016–-but mostly due to the market melting in January 2016. The Nasdaq Biotech Index collapsed 28% in the opening weeks of 2016 and… Read more »

Johnson & Johnson Tumbles as Pfizer Set to Launch Remicade Biosimilar; Solid 3rd Quarter Doesn’t Quell Market’s Overreaction

Thriving pharmaceutical sales drove stellar quarterly results for Johnson & Johnson (New Brunswick NJ), but the company’s shares fell 3% so far this week on worries that its smash hit,… Read more »

FDA Panel Supports Novartis Version of Amgen Arthritis Drug

By unanimous FDA panel vote, Novartis AG’s (Basel CHE) Enbrel (etanercept) biosimilar was approved across all of its U.S. licenses. The panel, which gives nonbinding advice to the agency, voted… Read more »

AbbVie Agrees to Buy Stemcentrx, Reports Jump in Earnings

U.S. biopharmaceutical firm AbbVie Inc. (North Chicago) on Thursday said it will acquire cancer biotech company Stemcentrx Inc. (South San Francisco) in a roughly $5.8 billion cash and stock deal that would expand… Read more »