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Chemistry World January 9, 2015 Rebecca Trager	US poised to approve its first 'biosimilar' drug A key committee of the US Food and Drug Administration has voted in favor of licensing a copycat version of a biological drug. If approved, Sandoz's Zarxio (filgrastim) would be the first 'biosimilar' drug available in the US.
Chemistry World May 14, 2015 Rebecca Trager	Injunction blocks first US biosimilar A US federal circuit court has granted a request by Amgen to temporarily block sales of the first biosimilar product approved by the US Food and Drug Administration
The Motley Fool February 22, 2011 Brian Orelli	A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S.
Chemistry World September 1, 2015 Rebecca Trager	FDA takes action to remove biosimilars roadblock In a move expected to facilitate the entry of biosimilar drugs into the US market, the US Food and Drug Administration has proposed a system for naming such copycat versions of biological drugs.
The Motley Fool February 25, 2008 Brian Orelli	Look Across the Pond for Biosimilars Teva, ratiopharm, and CT Arzneimittel all get positive recommendations for their new biosimilars, as approvals for generic equivalents to biotech drugs are heating up in Europe.
The Motley Fool July 18, 2011 Brian Orelli	A $3.6 Billion Franchise at Stake Amgen and Teva settle their patent dispute, and Amgen investors have a little better idea of when the company's $3.6 billion Neupogen and Neulasta franchise might come under attack in the United States.
Chemistry World February 14, 2012 Rebecca Trager	FDA proposes biosimilars approval pathway The US Food and Drug Administration has released its long awaited guidance to assist in the development and approval of so-called 'biosimilars' - biological drugs that are very similar to licensed ones.
The Motley Fool September 23, 2008 Brian Lawler	Will Generic Biologics Get Special Treatment? While the rest of the market was lost in the financial meltdown, a little-noticed report discussing some of the biopharmaceutical bills going through Congress was released.
Chemistry World April 24, 2008 James Mitchell Crow	FDA takes tough line on biologic drug The US Food and Drug Administration has rejected an application from biotechnology firm Genzyme to make its already-approved, protein-based drug Myozyme in larger batches.
The Motley Fool June 25, 2007 Brian Orelli	Leading the Pack of Follow-On Drug Makers Generic drug maker Dr. Reddy's Laboratories is taking a huge risk to get ahead of the pack, but it's well worth the rewards of being in front of its competitors. Investors, take note.
The Motley Fool June 29, 2010 Brian Orelli	The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.
The Motley Fool December 2, 2009 Brian Orelli	Tired of Waiting, Teva Advances Teva Pharmaceutical decides it's not worth waiting for the U.S. government to establish a pathway for approval of generic versions of biologic drugs. Instead, it's asking for approval for its copycat of Amgen's Neupogen under the normal branded-drug process.
Chemistry World June 10, 2013 Phillip Broadwith	Sandoz manufacturing woes continue Sandoz, the generic drugs arm of Swiss firm Novartis, has had an official warning from the US Food and Drug Administration over failings at one of its manufacturing plants.
The Motley Fool December 20, 2011 Brian Orelli	If You Can't Beat 'Em, Join 'Em: Amgen Goes Generic Biosimilars are coming -- might as well get a piece of the action.
The Motley Fool May 14, 2007 Mike Havrilla	A Weaker Amgen Amgen's stock is trading lower after an FDA panel balked at two anemia drugs.
Pharmaceutical Executive January 21, 2014 Ben Comer	Biosimilars or Bust Will biosimimilars make much of an impact on drug cost?
The Motley Fool March 17, 2008 Brian Lawler	The Panelling on Amgen's Walls One FDA panel ruling is a win, another is much less upsetting than investors feared.
The Motley Fool October 5, 2011 Arlene Weintraub	Merck Fine-Tunes Biosimilars Strategy as FDA Guidelines Loom Merck readies itself to enter this potential new market.
The Motley Fool April 24, 2007 Ryan Fuhrmann	Red and White Results at Amgen At current levels, this biotech titan could be worth a further look from investors.
The Motley Fool April 11, 2008 Brian Lawler	Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate.
The Motley Fool January 5, 2011 Brian Orelli	Spectrum Pharma Jumps in With the Big Dogs Spectrum is developing biosimilars.
The Motley Fool July 29, 2010 Brian Orelli	Buy, Sell, or Hold: Biotech Generics Generic biotech drugs are coming. Hop on.
The Motley Fool July 30, 2007 Brian Lawler	Amgen Adjusting Amgen's second quarter reflects the pain it's feeling with its top drugs. Investors, take note.
The Motley Fool July 31, 2009 Brian Orelli	Two Pictures of a Drug Company Who should we believe? The FDA? Mylan's earnings report?
The Motley Fool October 8, 2007 Brian Orelli	New FDA Regulations for Drugmakers To deal with a growing backlog of pending applications, the FDA plans to stop its first-come, first-served system.
Pharmaceutical Executive April 1, 2006 Jill Wechsler	Washington Report: A Warning Trend Washington's new answer to drug safety concerns is more warnings and more disclosure of undigested data. But warnings can go too far. Haven't FDA's critics ever heard the story of the boy who cried wolf?
The Motley Fool May 15, 2008 Brian Orelli	Wanted: FDA Approval -- Pronto Teva and Amphastar have the courts on their side, but the FDA still stands in the way of a generic-drug launch.
The Motley Fool December 20, 2011 Luke Timmerman	Amgen, Watson Strike $400M Deal for Biosimilar Cancer Drugs What does this important collaboration mean for biosimilars?
The Motley Fool January 21, 2009 Brian Orelli	A Copycat on the Prowl Teva Pharmaceutical announces it is partnering with Lonza to develop generic versions of biologics, called biosimilars, or follow-on biologics.
Pharmaceutical Executive July 1, 2011 Jill Wechsler	Battles over Biosimilars Sponsors must handle interchangeability, exclusivity, cost and coverage hurdles to win biosimilars game.
Chemistry World July 2, 2013 Phillip Broadwith	Biosimilar drugs step up complexity The first ever generic monoclonal antibody therapies have been recommended for approval in Europe.
The Motley Fool August 17, 2007 Brian Orelli	Fewer Drug Approvals? Buy! Stricter standards at the FDA could create a buying opportunity. Drug approvals are down one third this year, creating a lot of value in pharmaceutical and biotech companies. Just choose your medicines carefully.
The Motley Fool November 12, 2009 Brian Orelli	The Life-and-Death Situation That Isn't Branded-drug makers aren't playing fair because they refuse to sell samples to generic drug makers.
The Motley Fool June 2, 2010 Brian Orelli	Little Surprise. Big Stock Move. Investors like Amgen's early approval;shares are up 9% today, well ahead of the overall market.
The Motley Fool September 18, 2008 Brian Orelli	Ranbaxy's Troubles Won't Help Competitors The FDA will block the importing of more than 30 drugs and ingredients until Ranbaxy's problems at two Indian manufacturing plants are resolved.
The Motley Fool October 24, 2008 Brian Orelli	Amgen's Back Shares of Amgen are up 40% from their lows in March. And for good reason.
The Motley Fool November 20, 2006 Brian Gorman	Hospira's Bold Move The drug delivery outfit's stab at biosimilars is worth some attention, but investors shouldn't assume a major payoff.
The Motley Fool March 23, 2010 Brian Orelli	No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma.
The Motley Fool April 29, 2008 Brian Orelli	Will These Drugs Get FDA Approval? Discovery Laboratories and Adolor are waiting FDA decisions on their drugs next month.
The Motley Fool October 16, 2006 Brian Lawler	The Coming Generic Drug Boom Generic drugmakers are poised to profit from several key factors. Investors, take note.
The Motley Fool December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
The Motley Fool September 6, 2007 Brian Lawler	Amgen's Congressional Helpers Lawmakers push to ease restrictions on anemia compounds from Amgen and Johnson & Johnson. Investors, take note.
The Motley Fool September 10, 2007 Brian Lawler	Get a Glimpse of Amgen's Future Investors will want to pay attention to an FDA advisory panel meeting discussing new labeling recommendations for Amgen's anemia medications. The two drugs represented 44% of the pharmaceutical company's second-quarter revenue.
The Motley Fool September 7, 2011 Brian Orelli	J&J and Bayer Head in Front of the Firing Squad An expanded indication for Xarelto seems unlikely.
The Motley Fool October 31, 2011 Eric Bleeker	Where Amgen Is Finding Its Growth Five years ago, Amgen collected 83% of its sales from the United States.
The Motley Fool December 31, 2007 Brian Lawler	The Anatomy Of An Approved Drug An independent audit by the FDA provides a useful summary of the characteristics of drugs approved by the agency.
Chemistry World October 5, 2012 Phillip Broadwith	Teva pulls generic antidepressant The move was prompted by an FDA investigation into whether the generic version (Budeprion XL, made by Impax and marketed by Teva) is truly therapeutically equivalent to the branded medicine (Wellbutrin XL).
Managed Care February 2008 Martin Sipkoff	FDA Approach to Generics May Be a Mixed Blessing A recently announced initiative is supposed to speed approval of generic drugs, but does it address some fundamental flaws in the approval process?
The Motley Fool April 1, 2004 Charly Travers	Atrix Batting 1.000 Atrix Laboratories' drugs have breezed past the Food and Drug Administration.
Pharmaceutical Executive November 1, 2012 Jill Wechsler	Budgets, Biosimilars, and Bad Ads While the nation was embroiled in the presidential elections, a number of important legal and regulatory issues absorbed pharmaceutical executives.