Search results for " legislation"
Article
Biosimilars: Making the Switch Comes with Challenges
This legislation has since been supplemented by an overarching guideline on standards for quality, safety, and efficacy of the products, which has been followed by a series of guidelines on class-spec…
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Framing Biopharma Success in 2016
Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016.
By Rita C. Peters
The US biopharmaceutical industry turned a new page in 2015 when…
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GMP Challenges for Advanced Therapy Medicinal Products
The objective behind the guidelines is to bring together in a single document GMP standards from a variety of sources, mainly other pieces of EU legislation. But even when the first dedicated GMP guid…
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
May 04, 2015
By Randi Hernandez
The risks involved with patent suits may become a bit more undesirable, thanks to new legislation aimed at deterring unreasonable patent suits. A senate bill…
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The Bullish Outlook for Biosimilars
These efforts have included: patent litigation or extension; debates regarding nomenclature and product labeling; sponsoring legislation to prevent pharmacists from switching to biosimilars; and campa…
Article
Navigating Emerging Markets: Middle East and North Africa
On the pharmaceutical side, countries like Morocco have enacted legislation in the past decade to attract foreign investment in the country.
While the Middle Eastern environment remains unsett…