Search Results for biosimilars

Showing 1 – 25  of 101

Interchangeable Biosimilars vs. Biosimilars: Experts Explain Guidance, Discuss Development and Uptake By Zachary Brennan - Published 13 September 2017

Interchangeable biosimilars are headed to the US market over the next several years and discussion of the incoming products kicked off both the Biosimilars Council's conference on Wednesday and RAPS' Regulatory Convergence on Monday.

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

Tags: biosimilars, interchangeable biosimilars

The 505(b)(2) Pathway and Why Some Follow-on Insulins Aren’t Yet Biosimilars in the US By Zachary Brennan - Published 05 September 2017

Why has the European Medicines Agency (EMA) approved follow-on insulin products as biosimilars while the US Food and Drug Administration (FDA) has not? A look at several recent examples shows what is happening and what will change in the US over the next several years.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs

Tags: insulin, Merck, Lilly, Sanofi, Admelog, 505(b)(2), biosimilars

FDA Approves 6th Biosimilar in US, Second for Humira By Zachary Brennan - Published 28 August 2017

The US Food and Drug Administration (FDA) announced Friday that it has approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s blockbuster Humira (adalimumab).

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

Tags: biosimilars US approval, Boheringer Ingelheim, Cyltezo, Humira

European Regulatory Roundup: Ireland Starts Consultation on Biosimilar Policy (17 August 2017) By Nick Paul Taylor - Published 17 August 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU Regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs

Tags: European regulatory roundup, Ireland biosimilars, CROs

TGA Consults on Biological Naming By Michael Mezher - Published 28 July 2017

Australia's Therapeutic Goods Administration (TGA) on Friday launched a public consultation to gather feedback on proposals for potential biological naming systems, including options for EU- or US-aligned systems.

Categories: News, Oceania, TGA, Biologics and biotechnology

Tags: Biological Naming, Biosimilars, INN, Nonproprietary Name, Suffix, Biological Qualifier

FDA Panel Unanimously Backs Avastin and Herceptin Biosimilars By Michael Mezher - Published 13 July 2017

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday unanimously backed the approval of biosimilar versions of two of Roche's top selling cancer drugs, Avastin (bevacizumab) and Herceptin (trastuzumab).

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

Tags: Avastin, Herceptin, Biosimilars, ADP 215, MYL-1401O

Biological Products and Biosimilars: Global Naming Debate By Pallavi Trivedi - Published 27 June 2017

This article presents the contrasting views and continuing debate among health authorities in Australia, Canada, Europe, Japan and the US as well as industry experts regarding conventions for naming biological products and biosimilars. It discusses the World Health Organization's (WHO's) proposal for naming and the importance of a clear distinction between the drugs to avoid confusion and ensure patient safety.

Categories: News, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, PMDA, TGA, WHO, Biologics and biotechnology, Submission and registration

Tags: Biosimilars, Biosimilar Naming, Biological Qualifier, INN

FDA: Interchangeable Biosimilar Approvals Expected Within 2 Years By Zachary Brennan - Published 26 June 2017

The launch of the US biosimilars market has been slow since the pathway for approvals was set up in 2010, with only five US Food and Drug Administration (FDA) biosimilar approvals, none of which have been approved as interchangeable biosimilars.

Categories: News, US, FDA, Biologics and biotechnology, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: biosimilars, interchangeable biosimilars, interchangeability, biosimilar substitution

US Supreme Court: No Six-Month Wait for Biosimilars After FDA Approval By Zachary Brennan - Published 12 June 2017

The US Supreme Court on Monday ruled unanimously that biosimilar companies will not have to wait an additional six months after US Food and Drug Administration (FDA) approval before launching their new biosimilars.

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Business and Leadership, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Supreme Court of the United States, SCOTUS, biosimilars, patent dance

Biopharma Companies Take Issue With FDA's Draft Biosimilar Interchangeability Guidance By Zachary Brennan - Published 18 May 2017

Ahead of Friday's deadline for comments, a number of biopharmaceutical companies are seeking further clarification from the US Food and Drug Administration (FDA) on various aspects of the draft biosimilar interchangeability guidance.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Labeling, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development

Tags: biosimilars, interchangeability, FDA draft guidance, biosimilar guidance

Biosimilars in the EU: New IMS Report Shows Savings Through Competition By Zachary Brennan - Published 09 May 2017

A new report released Tuesday, prepared by QuintilesIMS at the request of the European Commission, found EU countries are saving lots of money from biosimilars even if market share is low.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: biosimilars, biologic competition, anti-TNF, HGH

WHO to Begin Cancer Biosimilar Prequalification Pilot This Fall By Michael Mezher - Published 04 May 2017

The World Health Organization (WHO) on Thursday announced it will invite biosimilar makers to participate in a pilot program to prequalify biosimilars of two top selling biologics this September in an effort bring lower cost versions of the products to low- and middle-income countries.

Categories: News, WHO, Biologics and biotechnology, Submission and registration

Tags: Biosimilars, Prequalification, Rituxan, Herceptin, Rituximab, Trastuzumab

Biosimilars Forum Seeks More Clarity in FDA Draft Guidance on Biosimilar Interchangeability By Zachary Brennan - Published 04 May 2017

The nonprofit industry group Biosimilars Forum is calling on the US Food and Drug Administration (FDA) to clarify that a demonstration of interchangeability represents a distinct requirement for additional data compared to a demonstration of biosimilarity.

Categories: News, US, FDA, Biologics and biotechnology, Due Diligence, Government affairs

Tags: biosimilars, FDA draft guidance, Biosimilars Forum

Asia Regulatory Roundup: Indian Watchdog Probes Allegations Roche Tried to Influence Regulators (2 May 2017) By Nick Paul Taylor - Published 02 May 2017

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Medtronic, Abbott, Roche, Herceptin, biosimilars

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

Strategies Adopted by Innovator Companies in Response to Biosimilars Competition By Charu Manaktala, MD, MBBS, Raymond A. Huml, MS, DVM, RAC, Nigel Rulewski, MD - Published 10 April 2017

This article examines key strategies being adopted by the innovator companies and discusses the impact these strategies are likely to have on the future market for biosimilars.

Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Government affairs, Regulatory strategy, Submission and registration

Tags: Biosimilars, Intellectual Property, Litigation, Patent Extension

FDA’s Draft Biosimilar Interchangeability Guidance: Stakeholders Seek More Clarity By Zachary Brennan - Published 04 April 2017

As comments on the US Food and Drug Administration’s (FDA) draft guidance on biosimilar interchangeability begin to trickle in, stakeholders seem optimistic and appreciative of the agency’s draft though some suggest tweaks to FDA's recommendations for switching studies.

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

Tags: interchangeable biosimilars, interchangeability, FDA draft guidance, comments on FDA guidance

Are Biosimilars 'Interchangeable' in the EU? A New Perspective By Zachary Brennan - Published 31 March 2017

The EU’s take on the class of medicines known as biosimilars is a slight variation of what is seen in the US, with the US creating two distinct types: Follow-on biologics that are biosimilar, or "expected to produce the same clinical result as the reference product," and ones that are "interchangeable," or able to be switched with their reference product.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology

Tags: interchangeable biosimilars, interchangeability, switching studies, biosimilar

FDA Transparency: Agency’s Hands Tied by its own Regulations By Zachary Brennan - Published 15 March 2017

Ask a US Food and Drug Administration (FDA) official how many biosimilar applications are actually under review, or the details of a recent Complete Response Letter (CRL), and he or she will explain how the agency cannot offer any more details than what is already publicly known, even if what has been made public is not aligned with reality.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: FDA transparency, CRLs, biosimilars

EU Industry Groups Urge Caution on Biosimilar Switching By Zachary Brennan - Published 09 March 2017

Three EU biopharmaceutical industry groups are offering key considerations to physicians when switching from a biologic reference product to its biosimilar or from one biosimilar of a reference product to another, according to a new position paper released on Thursday.

Categories: Europe, EC, EMA, Biologics and biotechnology, Compliance, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, biosimilar switching, regulatory requirements biosimilars

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

Genentech Files Complaint Over Amgen’s Development of Avastin Biosimilar By Zachary Brennan - Published 20 February 2017

Roche’s Genentech filed a complaint in Delaware District Court last week charging that Amgen, which is developing a biosimilar version of Genentech’s blockbuster cancer treatment Avastin (bevacizumab), has obstructed its ability to determine whether the manufacture and/or sale of Amgen’s biosimilar would infringe Genentech’s patents.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Regulatory intelligence, Submission and registration

Tags: Genentech, Roche, Avastin, Amgen, biosimilars

FDA Explains Why Newly Approved Biologic’s Name Lacks a Suffix By Zachary Brennan - Published 17 February 2017

The US Food and Drug Administration (FDA) approved a new biologic this week, but its name did not adhere to recently finalized guidance calling for all new and previously approved biologics and biosimilars to have a four-letter random suffix attached to their nonproprietary names.

Categories: News, US, FDA, Biologics and biotechnology

Tags: Valeant, Siliq, nonproprietary names of biologics, biosimilars

European Regulatory Roundup: House of Lords Backs Change to Drug Pricing Bill to Appease Pharma Industry (16 February 2017) By Nick Paul Taylor - Published 16 February 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Business and Leadership, Government affairs

Tags: European regulatory roundup, biosimilars, Brexit