Novartis Launches First U.S. ‘Biosimilar’ Drug at 15% Discount Novartis’ Zarxio is the biosimilar of Amgen’s biologic, Neuopgen. It is expected the due to the fact that Zarxio will be sold at cheaper price, it will increase access to treatment. Amgen had tried to stop Zarxio from reaching the market many times, but with no avail. … Continue reading Novartis Launches First U.S. ‘Biosimilar’ Drug at 15% Discount
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Everything you need to know
about biosimilars in one place
about biosimilars in one place
What Do Gastroenterologists Think About Biosimilars?
The American Gastroenterological Association surveyed 180 of its members on biosimilars and biologics. In late July, the American Gastroenterological Association released findings from a national survey of gastroenterologists on biosimilars and biologics. Biologics are used regularly for the treatment of inflammatory bowel disease (IBD), and biosimilars for the treatment of IBD, such as Remsima/Inflectra … Continue reading What Do Gastroenterologists Think About Biosimilars?
Read moreTrade Deal Could Effect Cost and Regulation of Biosimilars
For five years, the United States, along with 11 other countries have been negotiating the terms of the Trans- Pacific partnership, a trade deal between multiple Pacific Rim countries. In this deal, there is discussion on the pricing and regulation of drugs. Patents play a key role in the biosimilar industry. Many of the … Continue reading Trade Deal Could Effect Cost and Regulation of Biosimilars
Read moreZarxio Cleared for September Take-Off
The first U.S. biosimilar, Zarxio, should be on the market by September, after an appeals court ruled in its favour. In a move that has surprised some, Zarxio, the first FDA-approved biosimilar looks set for a September market launch after a U.S. appeals court ruled its maker had not violated any information disclosure requirements. … Continue reading Zarxio Cleared for September Take-Off
Read morePediatric Experts Caution Against Switching Kids with IBD to Biosimilars
European pediatricians say caution and long-term safety and efficacy studies are needed before switching children with IBD to biosimilars. A group of 10 pediatric specialists has published a statement calling for children with inflammatory bowel disease (IBD), who are already doing well on specific biologic medications, not to be switched to recently-approved biosimilar products. … Continue reading Pediatric Experts Caution Against Switching Kids with IBD to Biosimilars
Read moreThe Affordable Care Act and the Battle for Biosimilars
The passage of the Affordable Care Act (ACA) in 2010 opened up a pathway for the production and approval of biosimilar medications. Biosimilars are “copies” of complex biologic medical drugs, and are seen as cost-effective alternatives to expensive medications. So how did the regulations around biosimilars come to be? Steven Brill in his book … Continue reading The Affordable Care Act and the Battle for Biosimilars
Read moreU.K. Health Body Recommends Remicade Biosimilars Over Patented Reference Drug
Public health body NICE has favored two Remicade biosimilars ahead of the reference drug in draft guidance. The United Kingdom’s National Institute for Health and Care Excellence (NICE) has reportedly recommended two biosimilar versions of infliximab over Remicade, the top-selling original medicine patented by Janssen/MSD (Merck) – which makes more than $8 billion a year … Continue reading U.K. Health Body Recommends Remicade Biosimilars Over Patented Reference Drug
Read moreASBM Slams Australia for Backing Unsupervised Biosimilar Substitution
The Alliance for Safe Biologic Medicines calls the decision a “retrograde step” amid widespread global opposition to automatic biosimilar substitution by pharmacists. The Alliance for Safe Biologic Medicines (ASBM) has released a press release, condemning recent announcements by Australian Health Minister Sussan Ley and the Pharmaceutical Benefits Advisory Committee (PBAC) that Australia would “break … Continue reading ASBM Slams Australia for Backing Unsupervised Biosimilar Substitution
Read moreCancer Physicians Debate Biosimilars Uptake
Oncologist opinions on biosimilars and their impact on various market factors A number of the doctors interviewed by HemOnc Today disclosed affiliations with pharmaceutical companies, but their views still provide interesting insight to prevailing attitudes to biosimilars and health care. Uncertainty exists around the safety and efficacy of biosimilars, given they are similar, not … Continue reading Cancer Physicians Debate Biosimilars Uptake
Read moreAmgen vs. Sandoz: Court Hears Oral Arguments Over Zarxio’s Patent Breach
In the latest hearing over Zarxio’s alleged patent infringements, interpretation of the wording of the BPCIA was debated. After failing twice to block Zarxio’s market entry since 2014, Amgen won an 11th-hour reprieve in May 2015, when the U.S. Court of Appeals for the Federal Circuit in Washington, granted the company an injunction – … Continue reading Amgen vs. Sandoz: Court Hears Oral Arguments Over Zarxio’s Patent Breach
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