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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 July 29, 2010 Brian Orelli	Buy, Sell, or Hold: Biotech Generics Generic biotech drugs are coming. Hop on.
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.
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.
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 January 5, 2011 Brian Orelli	Spectrum Pharma Jumps in With the Big Dogs Spectrum is developing biosimilars.
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.
Chemistry World August 2, 2007 Victoria Gill	Europe Poised for a Surge in Generic Drugs The European Medicines Agency's Committee for Medicinal Products for Human use has recommended the approval of a schizophrenia treatment which is the first generic drug to be assessed under Europe's centralized procedure.
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 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.
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 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 August 31, 2007 Brian Lawler	Novartis on the Biosimilar Attack Novartis received final marketing approval today for only the second biosimilar product ever to gain a regulatory OK in the European Union. The EU market welcomes the drugmaker's copy of a treatment for anemia.
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 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 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.
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.
BusinessWeek November 3, 2003 Diane Brady	Biotech: Teva's Next Triumph? The Israeli maker of generics wants a piece of the fast-growing bio-drug market.
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 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 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 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 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 January 21, 2014 Ben Comer	Biosimilars or Bust Will biosimimilars make much of an impact on drug cost?
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.
Pharmaceutical Executive July 1, 2011 Jill Wechsler	Battles over Biosimilars Sponsors must handle interchangeability, exclusivity, cost and coverage hurdles to win biosimilars game.
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?
Pharmaceutical Executive April 1, 2014	Whatever Happened To Faster Reimbursement For Generics In Europe? The plan to accelerate generic pricing and reimbursement has become another tragic European casualty.
Chemistry World November 28, 2008 Matt Wilkinson	EU claims pharma delaying tactics cost 3 billion euros Pharmaceutical manufacturers have been criticised by the EU competition commission for slowing the entry of generic medicines to the market.
Managed Care February 2005 Thomas Morrow	Competition Heralds Beginning of Bio-Generics There is very little competition in the biopharmaceutical sector. With the introduction of generic forms of human growth hormone, can managed care get a lower price?
Chemistry World May 2006 Bea Perks	Editorial: Generics in the Dock The manufacturers of generic medicines in the U.K. must work harder to guard their good reputation. Or perhaps, manufacturers of generic medicines must work harder to counter their bad reputation.
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.
Pharmaceutical Executive October 1, 2010	Taking a Less-Generic Route to Generics A leading pharmaceutical industry player speaks out on what is fueling success in the sector.
Knowledge@Wharton	Drug Companies and the Patent Game: Fair Play or Foul? Is legal maneuvering a legitimate attempt by the big pharmaceutical companies to recover the huge costs of developing new drugs? Or are the brand-name firms inappropriately gaming the system for their own benefit, to the detriment of consumers and insurance companies?
The Motley Fool February 22, 2005 Brian Gorman	Novartis Embraces Generics The company is taking a different path from its branded pharmaceutical peers. The company's strategy may make its stock worth a closer look.
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 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 January 29, 2008 Brian Lawler	Genentech Adds to Avastin's Arsenal Genentech's lead drug Avastin gains another use -- just not the one investors expected.
Pharmaceutical Executive September 1, 2005 Sarah Houlton	Global Report: Kids 'R' EU After years of delay, the European Parliament is ready to vote on pediatric-testing legislation.
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 August 1, 2013 William Looney	Breaching the Great Wall With a revision of China's basic drug approval law now underway, a multinational team of experts is proposing major changes to make the country a world class player in innovation.
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 December 1, 2010	The Sum of All His Parts: Career Reflections of Europe's Chief Drug Regulator The European Medicines Agency is a unique institution, pursuing a mandate shared with a complex web of national and regional groups, each able to place a distinctive imprint around the delicate task of certifying the safety and efficacy of new drugs.
The Motley Fool February 15, 2011 Brian Orelli	Obama Hates Your Drugmaker The president's proposal in favor of earlier generics would mean lower profits for some companies.
The Motley Fool June 22, 2007 Brian Lawler	Novartis' Good Week The pharma receives a pair of positive regulatory decisions. Investors, take note.
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.
Chemistry World July 9, 2014 Hepeng Jia	China struggles to speed up drug reviews The China Food and Drug Administration is attempting to outsource some reviewing processes and introducing fast-track priority reviews for selected generic drugs.
Pharmaceutical Executive September 1, 2014 William Looney	Ireland's Celtic Tiger: Back on the Hunt Leaders from industry, government, and the CRO community examine Ireland's future as a magnet for life science investments, and what the nation must do to remain the leading exporter of finished pharmaceutical products.
Chemistry World November 21, 2008 Pete Mitchell	UK drug price deal finalised The new deal is guaranteed to continue for five years - a great relief to the industry.