Search Results for Sandoz

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Sandoz Raises Questions With FDA Draft Guidance on Statistical Approaches for Biosimilars By Zachary Brennan - Published 24 October 2017

Martin Schiestl, chief science officer at Novartis' Sandoz, on Tuesday explained how the US Food and Drug Administration's (FDA) draft guidance on statistical approaches to evaluate analytical similarity poses risks that could end up causing true biosimilars to be rejected randomly.

Categories: News, US, FDA, Biologics and biotechnology, Research and development

Tags: FDA draft guidance, biosimilars, Sandoz

Supreme Court Weighs Biosimilar Patent Dance By Zachary Brennan - Published 26 April 2017

All nine justices of the US Supreme Court gathered Wednesday to hear oral arguments from the lawyers of Novartis subsidiary Sandoz and Amgen, who took sides on what's known as the biosimilar "patent dance," and whether a notice of licensure 180 days prior to marketing is necessary.

Categories: News, US, FDA, Biologics and biotechnology, Drugs

Tags: Supreme Court, biosimilars, Novartis, Sandoz

US Supreme Court to Consider Biosimilar Patent Process Next Week By Zachary Brennan - Published 20 April 2017

The highest court in the US next Wednesday will take up a fight over the so-called biosimilar "patent dance" and whether biosimilar companies have to notify reference product sponsors of the impending marketing of a new product, likely leading to a decision with ramifications for all subsequent biosimilars approved by the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Ethics, Government affairs

Tags: biosimilars, Amgen, Sandoz, patents

Biosimilars Council Urges Supreme Court to Reject Additional Six Months Exclusivity for Biologics By Zachary Brennan - Published 20 February 2017

In an amicus brief filed on Friday, the Biosimilars Council, a division of the newly rebranded Association for Accessible Medicines (previously the Generic Pharmaceutical Association), argues that the US Supreme Court should not give biologic manufacturers an additional six months of market exclusivity beyond the “already-generous twelve years” granted.

Categories: News, US, Biologics and biotechnology, Government affairs, Research and development, Submission and registration

Tags: biosimilars, GPhA, AAM, Biosimilars Council, Amgen, Sandoz

Biosimilar Interchangeability: ‘Careful What You Wish For’ By Zachary Brennan - Published 08 September 2016

As the open question around interchangeable biosimilars in the US continues to drive the discussion on what the US Food and Drug Administration (FDA) will require for such a designation, some experts are saying the designation might not actually be that important for the biosimilar market as a whole.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Crisis management, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: interchangeability, biosimilars, biologics and biosimilars, Momenta Pharmaceuticals, Pfenex, Sandoz, GPhA

FDA Approves Third Biosimilar in US, First for Amgen's Blockbuster Enbrel By Zachary Brennan - Published 30 August 2016

The US Food and Drug Administration (FDA) on Tuesday approved Sandoz’s biosimilar to Amgen’s blockbuster Enbrel, which will be known as Erelzi (etanercept-szzs) for all indications included in the reference product’s label.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Due Diligence

Tags: biosimilar, Enbrel, Amgen, Novartis, Sandoz

Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels By Zachary Brennan - Published 03 August 2016

Drug, biologic and biosimilar companies’ comments on US Food and Drug Administration (FDA) draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label.

Categories: News, US, FDA, Biologics and biotechnology, Labeling

Tags: Novartis, Amgen, Pfizer, Sandoz, AbbVie, Takeda, Boehringer, biosimilar, labeling guidance, biosimilar labels, interchangeability

Back to Back: FDA Panel Offers Unanimous Thumbs Up for Sandoz’s Enbrel Biosimilar By Zachary Brennan - Published 13 July 2016

For a second straight day, the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee has unanimously pushed for the approval of a new biosimilar, this time for Sandoz’s biosimilar for Amgen’s Enbrel (etanercept).

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Submission and registration

Tags: Sandoz, Novartis, Enbrel, Humira, biosimilars

FDA Staff: Sandoz’s Enbrel Biosimilar is ‘Highly Similar’ to Amgen's Blockbuster By Zachary Brennan - Published 11 July 2016

Another clear sign that the US biosimilars market is off to a good start appeared on Monday, with staff of the US Food and Drug Administration (FDA) concluding that Sandoz’s biosimilar, known currently as GP2015, and Amgen’s blockbuster Enbrel (etanercept) are “highly similar.”

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Government affairs, Submission and registration

Tags: biosimilar, Enbrel, Amgen, Sandoz, Novartis

Asia Regulatory Roundup: China Fast Tracks Hepatitis C, Cancer Drug Approvals (26 April 2016) By Nick Paul Taylor - Published 26 April 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CFDA, Drugs, Government affairs, Medical writing, Product withdrawl and retirement, Quality

Tags: Harvoni, Sovaldi, CFDA inspections, Merck Serono, Sandoz

Sandoz Petitions Supreme Court to Rule on Biosimilars By Zachary Brennan - Published 17 February 2016

Sandoz has called on the US Supreme Court to review a lower court ruling that found biosimilar makers must wait an additional six months after US Food and Drug Administration (FDA) approval before bringing their product to market.

Categories: News, US, FDA, Biologics and biotechnology, Business Skills, Compliance, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Supreme Court, SCOTUS, biosimilar lawsuit, biosimilar litigation, Sandoz, Amgen, Apotex, Zarxio

FDA Likely to Require Substantial Clinical Data for Interchangeable Biosimilars, Lawyers Say By Zachary Brennan - Published 12 January 2016

The US Food and Drug Administration (FDA) is “almost certain” to require clinical data in order for companies to demonstrate interchangeability between a biosimilar and its reference product, though the question of how much data will be required is major factor in determining how quickly the US biosimilars market will take off, according to a new report from the law firm Goodwin Procter. 

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Government affairs, Manufacturing, Preclinical

Tags: biosimilars, interchangeability, 351(k) application, Amgen, Sandoz, biosimilar substitution

FDA Warns Sandoz, Dr. Reddy’s Indian Sites Over Data Integrity Violations By Zachary Brennan - Published 24 November 2015

Serious data integrity violations, including the backdating of records and failing to provide pertinent data to regulators, were included in warning letters for five manufacturing facilities from both Sandoz and Dr. Reddy’s in India, according to the US Food and Drug Administration (FDA).

Categories: News, India, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Clinical, Crisis management, Drugs, Government affairs, Manufacturing, Quality

Tags: Sandoz, Dr. Reddy's, FDA, warning letters, warning letters in India

FDA Approves US' First Biosimilar Product, but Regulatory Questions Remain By Alexander Gaffney, RAC - Published 06 March 2015

The US Food and Drug Administration (FDA) has announced the landmark approval of the US' first biosimilar product, Sandoz' Zarxio (filgrastim-sndz), a drug biologically similar to Amgen's Neupogen.

Categories: News, US, CDER, Biologics and biotechnology, Labeling, Submission and registration

Tags: Biosimilar, Biosimilar Approval, FDA Biosimilar, Neuopogen Biosimilar, Filgrastrim-sndz, Sandoz, Zarxio

Sandoz First Company to File for Biosimilar Approval in US Under New Pathway By Alexander Gaffney, RAC - Published 24 July 2014

Biopharmaceutical company Sandoz, a Novartis subsidiary, has announced that it has filed the first-ever biosimilar application in the US with the Food and Drug Administration (FDA) using its 351(k) pathway.

Categories: News, US, CDER, Biologics and biotechnology, Submission and registration

Tags: Biosimilar, Biosimilarity, Follow-on Biologic, Sandoz, 351(k), First Biosimilar Filing in US

Sandoz Announces Recall Due to Particulate Contamination, Citing Familiar Problems By Alexander Gaffney, RF News Editor - Published 21 May 2013

Categories: US, FDA

Tags: Sandoz, Methotrexate, Drug Shortage, Recall

Sandoz Issues Recall After Packaging Errors Found By Alexander Gaffney - Published 07 June 2012

Categories: Packaging

Tags: Blister Packs, Package, Intravole, Sandoz, Levonorgestrel, Birth Control, Novartis, Recall, Latest News

Health Canada Accelerating Approvals to Ease Drug Shortages By Alexander Gaffney - Published 19 March 2012

Categories: Canada, Health Canada

Tags: Fire, Sandoz, Latest News, Drug Shortages, NDA, review

Canadian Drug Shortages Lead to Calls for Regulation By Alexander Gaffney - Published 14 March 2012

Categories: Canada, Drugs, Manufacturing, Quality

Tags: Injectibles, Plant, Fire, Sandoz, Harper, Pharmaceuticals, Latest News, Drug Shortages, Shortage