Search Results for biosimilars

Showing 1 – 25  of 82

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

AbbVie, Novartis Criticize FDA’s Guidance on Nonproprietary Names for Biologics and Biosimilars By Zachary Brennan - Published 15 February 2017

Biopharmaceutical companies Novartis and AbbVie are taking issue with the US Food and Drug Administration’s (FDA) burdensome plan to require retroactive changes to the nonproprietary names of existing biologics and biosimilars, according to comments sent to the agency this week.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Labeling, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, nonproprietary names for biosimilars, nonproprietary names for biologics, FDA guidance

European Commission Offers New Q&A on Biosimilars By Zachary Brennan - Published 23 January 2017

The European Commission on Monday unveiled a new question and answer document for those looking to better understand biosimilars.

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

Tags: biosimilars, biosimilar workshop

US Supreme Court to Review Biosimilar ‘Patent Dance’ By Zachary Brennan - Published 13 January 2017

The US Supreme Court on Friday said that it will review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products.

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

Tags: SCOTUS, John Roberts, biosimilar patent dance, biosimilars and SCOTUS

FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars By Zachary Brennan - Published 03 January 2017

Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is necessary to support a proposed biosimilar.

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

Tags: clinical pharmacology data, biosimilars, reference products, FDA guidance

Lessons Learned from Biosimilar Drug Development By Raymond A. Huml, MS, DVM, RAC, Nigel Rulewski, MD - Published 19 December 2016

This article discusses the emerging US biosimilars market, including critical success factors, safety issues, extrapolation, choice of reference product, partnerships and alliance management, clinical trial recruitment and regulatory and commercial factors. It also describes an accelerated approach to biosimilar clinical development.

Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Preclinical, Regulatory strategy

Tags: Biosimilars

EMA to Launch Tailored Biosimilar Scientific Advice Pilot By Zachary Brennan - Published 16 December 2016

The European Medicines Agency (EMA) on Friday announced that it will launch a tailored scientific advice pilot project in February 2017 to support the development of new biosimilars.

Categories: News, Europe, EMA, Biologics and biotechnology, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, biosimilar scientific advice, biosimilar data

Global Developments of Biosimilars By Randolph Fillmore - Published 15 December 2016

This article was developed from presentations at the 2016 RAPS Regulatory Convergence meeting held in San Jose. The session titled "Biosimilars," was led by Arpita Shah, PharmD, senior manager, regulatory intelligence and policy, Celgene Corporation. Speakers included  Leah Christl, associate director, therapeutic biologics, FDA, CDER, Sabine Haubenreisser, MSc, PhD, EMA liaison official at the FDA and Tara Sanderson, associate director, project manager, CMC regulatory affairs, ERA Consulting.

Categories: Features, Asia, Canada, Europe, US, EMA, FDA, Health Canada, PMDA, Biologics and biotechnology

Tags: Biosimilars

US Solicitor General Calls on Supreme Court to Review Six-Month Delays to Biosimilar Launches By Zachary Brennan - Published 08 December 2016

With the timing of all future US launches of biosimilars at stake, the US Solicitor General has called on the Supreme Court to review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, US Supreme Court, Federal Circuit, biosimilar launch

Cassidy Says Obamacare Repeal Will Not Repeal Biosimilars Approval Pathway By Zachary Brennan - Published 07 December 2016

Sen. Bill Cassidy (R-LA) told attendees of a policy briefing at the Newseum on Wednesday that when Republicans repeal Obamacare, which is expected to occur soon after President-elect Donald Trump takes office, the approval pathway for biosimilars that was created thanks to that law will not go away.

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

Tags: Obamacare, ACA, biosimilars, Bill Cassidy

WHO Releases Draft Guidance on Postmarket Changes to Biologics By Michael Mezher - Published 03 November 2016

The World Health Organization's (WHO) Expert Committee on Biological Standardization (ECBS) recently released a new draft guideline detailing the agency's proposed approach to handling changes to approved biologics and biosimilars for public comment.

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

Tags: Biologics, Biosimilars, Postmarket Changes

FDA Officials Share Best Practices for Biosimilar Development By Michael Mezher - Published 28 October 2016

With industry interest in biosimilars continuing to grow, top officials at the US Food and Drug Administration (FDA) are urging sponsors to leverage agency advice and follow best practices to ensure the timely success of their biosimilar development programs.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Preclinical, Regulatory strategy

Tags: Biosimilars, BsUFA II

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

Woodcock on Biosimilars: Earning the Trust of Prescribers and Patients is Key By Zachary Brennan - Published 07 September 2016

Similar to earning the public’s trust and confidence on generic drugs more than 20 years ago, the biosimilar industry needs to work to establish the same pattern of trust and confidence now, Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, told attendees at the Generic Pharmaceutical Association’s (GPhA) biosimilar conference in Bethesda, MD, on Wednesday.

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

Tags: Janet Woodcock, GPhA, biosimilars, biosimilar education

Regulatory Explainer: Everything You Need to Know About Biosimilars By Zachary Brennan - Published 10 August 2016

For more than a decade now, biotech and pharmaceutical companies have brought a new class of treatments – biosimilars – to markets around the world (from the EU to India to South Korea to the US), offering cost savings for some of the most expensive medicines, though even in 2016, decades after companies began their quest to develop biosimilars, they are still only just beginning to see widespread adoption.

Categories: News, Africa, Asia, Europe, US, CDSCO, EMA, FDA, FTC, Health Canada, MHRA, Biologics and biotechnology, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: biosimilars, BPCIA, patent dance, biologics, biosimilar savings

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

BIO Opposes House Bill to Reduce Biologics Exclusivity From 12 to 7 Years By Zachary Brennan - Published 23 June 2016

Rep. Jan Schakowsky (D-IL) and three Democratic colleagues in the House took a jab at the biotech industry on Thursday, introducing a new bill that would reduce the amount of exclusivity for biologics from 12 years to seven years.

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

Tags: biologics exclusivity, biosimilars, BPCIA, market exclusivity

Biosimilars in the EU: Lower Costs, Increased Patient Access, IMS Report Finds By Zachary Brennan - Published 20 June 2016

For those tracking the contentious debate over drug and biologic price hikes in the US, an IMS Health report released on Monday offers the latest evidence yet that a robust biosimilars market can not only lower prices across drug classes but also increase patient uptake of such treatments.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Due Diligence, Government affairs, Postmarket surveillance, Quality, Research and development

Tags: biosimilars, EU uptake of biosimilar medicinal products, IMS Health, EPO, Anti-TNF, Humira, Enbrel, Remicade

Updated: Biosimilars in the US: Panel Discusses Tricky Balance of Building the Market With Necessary Precautions By Zachary Brennan - Published 20 June 2016

Biosimilar experts, including the US Food and Drug Administration's (FDA) Dr. Leah Christl and biosimilar developer Coherus Biosciences' chief medical officer Dr. Barbara Finck, sat down on Monday at an Alliance for Health Reform event to discuss the challenges the US faces in developing a robust biosimilars market and also ways the US can avoid fear mongering and increase uptake.

Categories: News, US, CBER, Biologics and biotechnology, Clinical, Government affairs, Quality, Research and development

Tags: biosimilars, interchangeability, BPCIA

Pharma Companies Warn of Regulatory ‘Dead Zone’ With FDA’s Interpretation of BPCIA By Zachary Brennan - Published 27 May 2016

Sanofi, Mylan, Novo Nordisk, and industry groups PhRMA and the Biosimilars Council are all calling on the US Food and Drug Administration (FDA) to amend its interpretation of the "deemed to be a license" provision of the Biologics Price Competition and Innovation Act (BPCIA) of 2010 as some are saying the current draft guidance could halt biosimilar development for a prolonged period.

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Compliance, Product withdrawl and retirement

Tags: Sanofi, Mylan, PhRMA, GPhA, biosimilars, BPCIA