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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 February 22, 2011 Brian Orelli	A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S.
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.
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.
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
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 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 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.
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.
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.
The Motley Fool July 29, 2010 Brian Orelli	Buy, Sell, or Hold: Biotech Generics Generic biotech drugs are coming. Hop on.
The Motley Fool January 5, 2011 Brian Orelli	Spectrum Pharma Jumps in With the Big Dogs Spectrum is developing biosimilars.
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 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.
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.
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 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.
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.
Pharmaceutical Executive January 21, 2014 Ben Comer	Biosimilars or Bust Will biosimimilars make much of an impact on drug cost?
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 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.
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.
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 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 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 February 16, 2010 Brian Orelli	For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward.
The Motley Fool June 20, 2011 Brian Orelli	See Drug, Approve Drug An approval of Regeneron's macular degeneration Eylea looks likely.
Pharmaceutical Executive March 1, 2012 Ron Cohen	FDA's Necessary Dose of Reality There's no fast-acting salve, but there are several steps that can be taken to streamline many of the procedures at FDA. And it begins with leadership.
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 January 14, 2008 Brian Lawler	Score One for Dendreon and Disclosure A prestigious journal supports Dendreon's potential prostate cancer treatment, and makes a compelling case for more FDA disclosure.
The Motley Fool September 9, 2010 Brian Orelli	Will These Drugs Get Past the FDA This Month? See what the FDA has on its decision calendar for the rest of September.
The Motley Fool April 1, 2004 Charly Travers	Atrix Batting 1.000 Atrix Laboratories' drugs have breezed past the Food and Drug Administration.
The Motley Fool December 31, 2007 Brian Lawler	Lower Expectations for Theravance The FDA decides to debate Theravance's lead drug, Telavancin, leading to a drop in share price.
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 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 July 30, 2007 Jill Wechsler	Washington Report: Exclusivity vs. Patents To encourage innovation while supporting access to less costly therapies, Congress proposes an extensive data-exclusivity period that would delay Food and Drug Administration approval of a follow-on biologic application for 12 years.
The Motley Fool October 26, 2007 Brian Orelli	Investing in Follow-On Biologics Investors, while approvals of follow-on biologics in the U.S. are probably still years away, now is the time to do your research. Those that are leading the race overseas are likely to be first in line when the FDA opens its door to applications.
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 March 8, 2010 Brian Orelli	Really? A 59% Share Price Jump for That? Justified or not, InterMune skyrockets ahead of an FDA panel meeting.
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 December 4, 2007 Brian Orelli	An Early Gift to Drugmakers Drugmakers could be allowed to market for drugs' off-label indications.
The Motley Fool July 12, 2011 Luke Timmerman	Seattle Genetics' New "Empowered Antibody" Looks Clean in FDA Staff Documents FDA reviews Seattle Genetics' Hodgkin's lymphoma drug.
The Motley Fool April 11, 2008 Brian Lawler	Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate.
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 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.
The Motley Fool October 15, 2009 Robert Steyer	Little Discord on Acorda Drug FDA advisory panel overwhelmingly backs a drug to improve the walking ability of multiple sclerosis patients.
Chemistry World May 14, 2015 Rebecca Trager	FDA accused of violating drug company's freedom of speech The US Food and Drug Administration is under pressure to reconsider its policy prohibiting pharmaceutical companies from promoting 'off-label' uses of their products.
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.
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.