je.st
news
Tag: biosimilar
FDA Denies Amgen's Citizen Petition Regarding Biosimilar Applicant Requirements
2015-04-03 07:01:53| Biotech - Topix.net
Late last week, the U.S. Food and Drug Agency dismissed a citizen petition filed by Amgen, Inc. asking the agency to require that biosimilar applicants provide the reference product sponsor with a copy of their application and information on their manufacturing processes. At issue is the meaning of the term " shall " and whether the information-sharing and advance-notice provisions of the Biologics Price Competition and Innovation Act that a biosimilar applicant "shall providea copy of the application submitted [to FDA]and such other information that describes process or processes used to manufacture the biological product" is a mandatory requirement or an optional action for the biosimilar applicant.
Tags: requirements
citizen
applicant
petition
U.S. judge rejects Amgen bid to block 'biosimilar' Neupogen
2015-03-19 22:40:00| Biotech - Topix.net
A U.S. judge on Thursday denied Amgen Inc's bid to block the sale of Novartis AG's recently approved "biosimilar" form of Neupogen, Amgen's blockbuster drug used to prevent infections in cancer patients. The drug, Zarxio, contains the same active ingredient as Amgen's $1.2 billion-a-year Neupogen, and once launched, would become the first biosimilar in the United States.
BIO addresses FDA approval of biosimilar product.
2015-03-10 13:31:09| Industrial Newsroom - All News for Today
BIO issued statement regarding approval by FDA of the first biosimilar product under the pathway created by the Biologics Price Competition and Innovation Act. According to Jim Greenwood, BIO President and CEO, for more than a decade, BIO has called for open, transparent, and science-based dialogue regarding biosimilars. It is unfortunate that the lack of publicly available naming guidance resulted in FDA's assignment of a "placeholder" name for approved biosimilar.
Tags: product
approval
addresses
bio
Novartis Wins FDA Approval For Zarxio, First Biosimilar Drug In The US
2015-03-06 22:24:27| Biotech - Topix.net
U.S. regulators on Friday gave a green light to sales of the country's first copied version of a biotechnology drug, or "biosimilar," with approval of Novartis' white blood cell-boosting Zarxio. The drug contains the same active ingredient as Neupogen, or filgrastim, which logged 2014 worldwide sales of $1.2 billion for manufacturer Amgen.
Biosimilar copies of blockbuster drug launch in major EU markets
2015-02-25 12:59:55| Biotech - Topix.net
Cheap versions of a top-selling drug for rheumatoid arthritis and Crohn's disease are being launched across major European markets in an important advance for a new type of medicines known as biosimilars. The products from South Korean firm Celltrion and its partners Hospira and Mundipharma will compete with Remicade, the original branded drug from Johnson & Johnson and Merck & Co.
Tags: major
drug
copies
markets