Search Results for Biosimilar

Showing 1 – 25  of 99

Evaluating Analytical Similarity: Stakeholders Raise Questions With FDA Draft Guidance By Zachary Brennan - Published 04 December 2017

Biopharma companies and industry groups, including Pfizer, Genentech, Boehringer Ingelheim and the Biosimilars Council, have raised detailed questions in recently released comments on the US Food and Drug Administration’s (FDA) draft guidance on statistical approaches to evaluate analytical similarities for biosimilars.

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

Tags: biosimilar guidance, analytical similarity

FDA Approves Eighth Biosimilar, First for Cancer Drug Herceptin By Zachary Brennan - Published 01 December 2017

The US Food and Drug Administration (FDA) on Friday approved the first biosimilar to Roche’s breast and stomach cancer drug Herceptin (trastuzumab). Mylan and Biocon’s biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India.

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

Tags: Herceptin, biosimilar, FDA approval

EMA Backs Six Drugs, One Biosimilar for EU Approval By Michael Mezher - Published 10 November 2017

The European Medicines Agency (EMA) on Friday said that its Committee for Medicinal Products for Human Use (CHMP) is recommending six new drugs, a biosimilar and three generic medicines for EU approval.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Submission and registration

Tags: Marketing Authorization Applications, CHMP, Accelerated Assessment, Orphan Designation, Biosimilar, Jorveza, Prevymis, Ocrevus, Adynovi, Fasenra, Intrarosa, Mvasi

CMS Shift on Biosimilar Reimbursement Under Part B: What to Expect By Zachary Brennan - Published 06 November 2017

The Centers for Medicare and Medicaid (CMS) last week announced a major shift in how it will reimburse for biosimilars under Medicare Part B, and though the agency and market might not see the full impact of the decision for another decade, experts explained to Focus what the change will likely mean in the near and long term.

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

Tags: biosimilars, Medicare Part B, biosimilar reimbursement

CMS Revisits Biosimilar Payment Policy: Industry Comments Signal Expected Changes By Zachary Brennan - Published 30 October 2017

A tweak to a Centers for Medicare and Medicaid Systems (CMS) billing code system that could come later this week would have a big impact in making US biosimilars more competitive with their reference products.

Categories: News, US, Biologics and biotechnology, Regulatory intelligence, Regulatory strategy

Tags: J-code, HCPCS, biosimilar coding

Will FDA Add Suffixes to Approved Biologics' Names? By Zachary Brennan - Published 20 October 2017

Back in January, the US Food and Drug Administration (FDA) finalized guidance on how biosimilars and their biologic reference products' names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name.

Categories: News, US, FDA, Biologics and biotechnology

Tags: biosimilars, biosimilar naming

WHO Will Hold Off on Using Biological Qualifiers for Biosimilars By Zachary Brennan - Published 19 October 2017

No consensus has been reached on whether the World Health Organization (WHO) should continue with its biological qualifier proposal in assigning international nonproprietary names for biosimilars, and WHO says it "will not be proceeding with this at present," according to an October report.

Categories: News, Asia, Europe, US, WHO, Biologics and biotechnology, Labeling, Postmarket surveillance

Tags: biological qualifier, biosimilar naming

Abbvie, Amgen Deal on Humira Biosimilars Likely to Cost CMS More Than $1B By Zachary Brennan - Published 02 October 2017

Late last week, Amgen and AbbVie settled litigation over when competition for the world’s best-selling biologic Humira (adalimumab) will hit the market, and for the US, the settlement decided on 31 January 2023, while the EU will see competition 16 October 2018.

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

Tags: AbbVie, Amgen, Humira, biosimilar, CMS

European Regulatory Roundup: Medtech Industry Pressures Brexit Negotiators to Maintain UK-EU Relationship (21 September 2017) By Nick Paul Taylor - Published 21 September 2017

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

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European Regulatory Roundup, Brexit, biosimilar switching, vaccines

FDA Offers Draft Guidance on Statistical Approaches to Evaluating Similarity for Biosimilars By Zachary Brennan - Published 21 September 2017

The US Food and Drug Administration (FDA) on Thursday released another piece of the biosimilars puzzle for industry, offering new draft guidance on the type of information a sponsor should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical similarity assessment plan and the statistical approaches recommended for evaluating analytical similarity.

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

Tags: biosimilar guidance, analytical similarity, FDA guidance

FDA Approves First Biosimilar Cancer Treatment By Zachary Brennan - Published 14 September 2017

The US Food and Drug Administration (FDA) on Thursday approved Amgen’s biosimilar to Roche’s cancer treatment Avastin (bevacizumab). Amgen's biosimilar was approved under the brand name Mvasi (bevacizumab-awwb).

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

Tags: Amgen, Mvasi, Avastin biosimilar

WHO to Launch Pilot to Prequalify Biosimilars By Zachary Brennan - Published 05 September 2017

The World Health Organization (WHO) announced Tuesday that in October it will launch a pilot project for prequalifying biosimilars as part of its work to make some of the most expensive treatments for cancer more widely available in low- and middle-income countries.

Categories: News, WHO, Biologics and biotechnology, Drugs

Tags: biosimilar prequalification, WHO prequalification

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

European Regulatory Roundup: Merck Accused of Blocking Remicade Biosimilars (25 May 2017) By Nick Paul Taylor - Published 25 May 2017

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

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

Tags: Remicade biosimilar, ENVI, whistleblowers

FDA Panel Backs Hospira's Epogen Biosimilar in 14-1 Vote By Michael Mezher - Published 25 May 2017

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday voted 14-to-1 in support of approving Pfizer subsidiary Hospira's proposed biosimilar to Amgen's anemia drug Epogen (epoetin alfa) for all four of its indications.

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

Tags: Epoetin alfa, Epogen, Hospira, Pfizer, Amgen, Biosimilar

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

Congress Calls on HHS to Reverse Biosimilar Reimbursement Policy By Zachary Brennan - Published 12 May 2017

Sen. Pat Roberts (R-KS), and Reps. Joe Barton (R-TX) and Anna Eshoo (D-CA) as well as 52 other representatives and nine senators sent letters to Tom Price, Health & Human Services Secretary and Seema Verma, administrator for the Centers for Medicare & Medicaid Services (CMS), with concerns about the biosimilar reimbursement policy from a recently issued final rule.

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

Tags: biosimilar reimbursement, HCPCS, reimbursement code, CMS

FDA Approves 5th Biosimilar, 2nd for Remicade By Zachary Brennan - Published 21 April 2017

The US Food and Drug Administration (FDA) on Friday announced its fifth biosimilar approval: Samsung Bioepis’ Renflexis (infliximab-abda), an intravenous infusion for multiple indications.

Categories: News, US, FDA, Biologics and biotechnology

Tags: biosimilar, FDA approval

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

Updated: Duplicate MAAs: Amgen Wins EU-wide Approval for Two Humira Biosimilars By Zachary Brennan - Published 24 March 2017

The European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars to AbbVie's blockbuster biologic Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab).

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Government affairs, Regulatory strategy, Submission and registration

Tags: Humira biosimilar, duplicate MAA, Amgen, Pfizer, Enbrel

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

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

FDA Issues Long-Awaited Biosimilar Interchangeability Guidance By Michael Mezher - Published 17 January 2017

The US Food and Drug Administration (FDA) on Tuesday released for public consultation its long-awaited draft guidance detailing the agency's expectations for demonstrating biosimilar interchangeability.

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

Tags: Biosimilar, Biosimilar Interchangeability, Draft Guidance, Switching Study

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