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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.  |
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 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 January 5, 2011 Brian Orelli |
Spectrum Pharma Jumps in With the Big Dogs Spectrum is developing biosimilars.  |
The Motley Fool June 26, 2009 Brian Orelli |
Novartis Leads the Pack Biosimilars come to Japan; will the U.S. be next? In the U.S., the main hang-up is how much guaranteed patent protection branded biologics will be given.  |
Pharmaceutical Executive June 1, 2009 John F. Kouten |
On the Right Pathways With staggering year-over-year growth, biosimilars are "the future of medicine." Marketers must position their companies for the inevitable changes. President Barack Obama has pledged support for legislation governing biosimilars.  |
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 March 23, 2010 Brian Orelli |
No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma.  |
Managed Care April 2007 Martin Sipkof |
Abbreviated Approval Process In the Works for 'Biosimilar' Drugs The Access to Life-Saving Medicine Act may be a first step to giving the FDA the legal authority to approve these drugs.  |
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.  |
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 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 March 3, 2009 Brian Orelli |
Stop Worrying About Follow-On Biologics They're inevitable, but they won't hurt biotech as much as you might think.  |
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 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.  |
Pharmaceutical Executive October 1, 2012 J. Michael Nicholas |
Complex Drugs and Biologics: Policy Considerations in Brazil The Brazilian government's policy on biologics doesn't adequately address non-biologic complex drugs. Additional guidance is needed to bring these important medicines to market.  |
The Motley Fool November 6, 2006 Brian Lawler |
The Impending Verdict on Momenta The drug developer isn't willing to wait for potential legislation on generic drugs. Investors, take note.  |
The Motley Fool May 31, 2006 Brian Gorman |
Novartis Gets Its Way FDA approval for Omnitrope suggests Novartis has a bright future in biogenerics, and that's good news for the company's investors.  |
Chemistry World March 10, 2015 Rebecca Trager |
US approves biosimilar filgrastim Sandoz's Zarxio is a generic version of filgrastim, which Amgen markets as Neupogen.  |
The Motley Fool July 29, 2010 Brian Orelli |
Buy, Sell, or Hold: Biotech Generics Generic biotech drugs are coming. Hop on.  |
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?  |
Pharmaceutical Executive February 1, 2006 Sarah Houlton |
Global Report: Moving Towards Generic Biologics The European Medicines Agency hopes to complete its guidelines for the approval of biosimilar drugs early this year, paving the way for the approval of biogenerics - and a potential goldmine for the generics companies.  |
Pharmaceutical Executive September 1, 2011 Jill B. Conner |
Complex Biologics: The View from Teva Industry and regulators alike must grapple with the sensitivities associated with developing bio-similar drugs.  |
Pharmaceutical Executive July 1, 2011 Jill Wechsler |
Battles over Biosimilars Sponsors must handle interchangeability, exclusivity, cost and coverage hurdles to win biosimilars game.  |
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.  |
Pharmaceutical Executive April 1, 2011 |
Winning Beyond the Molecule It can take both a clinical and non-clinical approach to win the differentiation competition.  |
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.  |
Pharmaceutical Executive February 1, 2009 Jill Wechsler |
Securing Savings A close look at the healthcare industry will separate real cost-cutting measures from money-saving myths.  |
The Motley Fool September 20, 2005 Brian Gorman |
Novartis Stays Focused New developments at the drug giant suggest the company is on track. Investors, take note.  |
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.  |
Chemistry World March 25, 2010 Rebecca Trager |
Big pharma scores in US healthcare reform President Obama has signed the biggest US healthcare reform since the 1960s, and although it is largely seen as a victory for the pharmaceutical industry, some analysts are characterising it as a 'double-edged sword'.  |
The Motley Fool September 9, 2010 Jim Mueller |
Today's Buy Opportunity: Teva Pharmaceutical Take advantage of this growing generic-drug maker.  |
The Motley Fool October 3, 2008 Brian Orelli |
Amgen Draws Blood in Anemia-Drug War The pharmaceutical fights off rival Roche.  |
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 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.  |
Chemistry World December 22, 2011 Sarah Houlton |
Pharma braces for patent cliff impact It remains to be seen quite how far Lipitor sales will fall. Ranbaxy has six months of exclusivity for generic competition.  |
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 October 16, 2006 Brian Lawler |
The Coming Generic Drug Boom Generic drugmakers are poised to profit from several key factors. Investors, take note.  |
Pharmaceutical Executive May 6, 2014 Ben Comer |
The Brands of Yesteryear: Where Are They Now? We check back with previous Pharm Exec Brand of the Year winners like Januvia, Abbvie, and Gilenya to see how things are going.  |
Pharmaceutical Executive May 1, 2007 Jill Wechsler |
Washington Report: Pathways for Proteins The push is on to establish an approval pathway for generic versions of biotech therapies. Innovators want exclusivity and clinical studies for follow-on biologics, but visions of billion-dollar savings may short-circuit the scientific debate.  |
The Motley Fool December 12, 2007 Brian Lawler |
Patent Bill Is No Panacea A new bill that was meant to strengthen the patent and other intellectual-property rights of drugmakers doesn't do enough to encourage pharma innovation.  |
Chemistry World June 30, 2014 Phillip Broadwith |
Inhaled insulin approved in US Mannkind's Affreza is aimed at reducing the need for patients to inject themselves with insulin so frequently.  |
Chemistry World December 17, 2015 Sarah Houlton |
Pills, prices and politics Pharmaceutical pricing has been a hot topic in 2015, with the drugs bill continuing to rise as costly new treatments reach the market.  |
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.  |
Pharmaceutical Executive May 1, 2011 Stan Bernard |
Competition 2.0: Brands vs. Generics Innovator and generics companies are colliding as they invade each other's turf.  |
The Motley Fool December 20, 2007 Brian Orelli |
2007: The Year Pharma Fell in Love With Biologics The reason for pharma's newfound infatuation for biotech is quite clear. Many pharmaceutical companies are facing a patent cliff in the coming years, and they need to replace their blockbusters with something.  |
Chemistry World September 11, 2013 Phillip Broadwith |
First biosimilar antibody drugs approved in Europe The European commission has given final marketing approval to the first generic versions of monoclonal antibody drug infliximab (Johnson & Johnson's Remicade).  |
The Motley Fool June 11, 2009 Brian Orelli |
The FTC Hates You, Too The agency weighs in (unhappily) on follow-on biologics.  |
The Motley Fool April 17, 2006 Brian Gorman |
Novartis Presses on Biogenerics The company wins a court case that could accelerate U.S. regulations for biogenerics. Recent developments suggest Novartis' strategy may be close to paying off. Investors, take note.  |
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.  |