Biosimilar
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May 22, 2012 at 00:51 | Source: Business Standard
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Analysts forecast the Global Biosimilar market to grow at a CAGR of 52.2 percent over the period 2010–2014. One of the key factors contributing to this market growth is the rise in patent expirations of branded biopharmaceuticals. The Global Biosimilar ...
May 18, 2012 at 11:18 | Source: Transworld News
Last week, the U.S. Food and Drug Administration held a public hearing on the Draft Guidance on Biosimilar Development, where researchers, payors, patient and physician groups, and industry advocates provided their thoughts on the FDA's first attempt to ...
May 21, 2012 at 17:27 | Source: jdsupra.com
"As a leading provider of high quality biologic medicines, Amgen appreciates the challenges of developing and manufacturing innovative and biosimilar medicines." "Put patients first and sound policy will follow," Miletich states. "Amgen ...
May 29, 2012 at 01:54 | Source: Yahoo Finance
Viropro, Inc. creates a technology subsidiary to focus on the burgeoning International market for biosimilar drug therapeutics. Over the past year, several of the large pharmas have tied up with Contract Research Organizations (CROs) and/or with ...
May 16, 2012 at 14:20 | Source: Genetic Engineering News
In light of the upcoming FDA guidance for biosimilar approval, Novation has released a white paper, "Biosimilars – FDA Guidance Update," to help hospitals and health care providers better understand the key components of the FDA's draft guidance ...
May 13, 2012 at 16:39 | Source: AUTO-MOBI.info (press release)
It's small (for a protein) and has come from both animal and E. coli sources for decades. There's even a set of biosimilar insulin guidelines from the EMA, so approval should be easy. Biosimilar Insulin: Not a Piece of Cake As of now, all of the insulins ...
May 15, 2012 at 23:54 | Source: Genetic Engineering News
“BIOS’ (Biocon’s) shares have had an uninspiring run post the termination of the PFE (Pfizer) deal, which dealt a body blow to its biosimilar insulin aspirations. Whilst the deal is now terminated, it will continue to throw its shadow over future ...
May 21, 2012 at 19:07 | Source: Business Standard
Doctors have explained Iran is making significant advances in genetics and in the fields of biosimilar and biotechnology drugs. 12 countries in the world produce bio-tech drugs, which Iran is one of them. Doctors also explained with sanctions brought by ...
May 21, 2012 at 12:19 | Source: Presstv
Collected fees will be used to expedite the review process of biosimilar biological product applications, including post-market safety activities. Under the FDA agreement, the biosimilar application fee will be waived for a small business ...
May 3, 2012 at 23:53 | Source: Forbes
The Food and Drug Administration would probably urge makers of such biosimilar drugs to move ahead with plans to file for approval through the existing regulatory process. All of these practices could come to haunt the pharmaceutical industry ...
May 24, 2012 at 14:10 | Source: Reuters