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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 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.
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.
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 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 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 February 22, 2011 Brian Orelli	A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S.
Pharmaceutical Executive January 21, 2014 Ben Comer	Biosimilars or Bust Will biosimimilars make much of an impact on drug cost?
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 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.
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 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.
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.
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'.
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.
Managed Care January 2007 John Carroll	Debate Over Biologics Heats Up in Congress One of the possible issues is 'biosimilars,' agents that would fill the role that generics play in traditional pharmacy coverage.
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 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.
The Motley Fool March 23, 2010 Brian Orelli	No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma.
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 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.
Pharmaceutical Executive April 1, 2011	Revisiting Reform Courts, Congress review policies and programs shaping drug costs and access.
Pharmaceutical Executive April 1, 2009 Jill Wechsler	Kickoff for Reform In addition to overhauling healthcare, Congress is weighing proposals for updating FDA policies and expanding access to drugs.
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 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 January 1, 2012 Jill Wechsler	New Year, New Issues Look for action in 2012 on drug access, shortages, innovation, and transparency. The 800-pound gorilla in the room is the looming Supreme Court decision on the constitutionality of the Obama health reform legislation.
Pharmaceutical Executive January 1, 2014 Jill Wechsler	Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing
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.
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 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.
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.
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?
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.
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 January 13, 2011 Brian Orelli	This Trendy Pharma Is Making a Stylish Move Merck signs up a CRO to help with biosimilars.
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.
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.
Pharmaceutical Executive August 1, 2012	Sunny Outlook for Biopharm 2020? Albert Wertheimer looks beyond today's dark clouds with a comparatively sunny forecast for the biopharm industry in 2020. Just watch out for the harsh light of complacency.
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 June 11, 2009 Brian Orelli	The FTC Hates You, Too The agency weighs in (unhappily) on follow-on biologics.
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.
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 February 13, 2009 Brian Orelli	The Easy Way to Develop Drugs Merck buys a pipeline of follow-on biologics and a building to produce them.
The Motley Fool October 3, 2008 Brian Orelli	Amgen Draws Blood in Anemia-Drug War The pharmaceutical fights off rival Roche.
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.
The Motley Fool June 16, 2009 Brian Orelli	Going Viral, but Not in a Good Way Genzyme's manufacturing problems with viruses underscore the complexity of manufacturing biologic drugs compared to small molecule drugs.
Pharmaceutical Executive April 1, 2011	The Big Business of Boosting Performance Dutch-based DSM N.V. is seeking innovative ways to partner through bolstering manufacturing.
Managed Care September 2003 Thomas Morrow	Managed Care Strategy: Create Competition In Expanding Biotech Field The biotech field is booming, and insurers are scrambling to find ways to deal with the high costs of new "biologic" treatments. One strategy is to try to create more competition among the producers of biotech drugs.