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    European Regulatory Roundup: EMA Maps International Regulatory Coordination (12 January 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Maps International Regulatory Coordination Initiatives to Show Overlaps, Gaps The European Medicines Agency (EMA) has mapped cooperative regulatory initiatives to better understand how and where international peers are working together. EMA found there were a “myriad of initiatives but no strategic coordination,” prompting it to warn regulators are duplicating effo...
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    Asia Regulatory Roundup: India Adopts Risk-Based Approach to Biologic Licenses (20 December 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Adopts Risk-Based Approach to Biologic Licenses, Ending Mandatory Inspections The Drug Controller General of India (DCGI) has scrapped the need for manufacturers to undergo a joint inspection before receiving certain biologics licenses. Instead of conducting pre-approval visits, Indian regulators will award Form 29 licenses within three days of receiving applications ...
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    Arizona Becomes 21st State to Pass a Law Restricting Biosimilar Substitution at Pharmacies

    Arizona Gov. Doug Ducey (R) late last week signed into law a bill that would restrict which types of biosimilars pharmacists in the state can substitute biologics for. Hailed as a victory by industry group BIO , the law, like the 20 similar laws passed before it , is helping to create a patchwork of regulations governing how biosimilars are dispensed, even before biosimilars have hit the market en masse in the US. In the EU, however, the uptake of biosimilars, much l...
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    FDA Amends Regulations on General Biologic Standards for First Time Since 1977

    The revisions to US Food and Drug Administration’s (FDA) regulations, announced Tuesday, are designed to remove unnecessary or outdated biologics requirements and allow industry to employ new manufacturing technology and testing capabilities. Issued directly as a final rule – because FDA says it believes the updates include “only noncontroversial amendments” and FDA anticipates no major objections from industry – the new regulations are part of FDA’s continuing effort to...
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    FDA Sets Policy for Granting New Biologic Medicines Extensive Market Exclusivity

    The US Food and Drug Administration (FDA) today released a new draft guidance document intended to explain how biological products approved under Section 351(a) of the Public Health Service Act (PHS Act) are given periods of market exclusivity. Background Under the Patient Protection and Affordable Care Act's (PPACA) Biologics Price Competition and Innovation Act (BPCI), new biological products are eligible for 12 years of market exclusivity during which time the US...
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    Sandoz First Company to File for Biosimilar Approval in US Under New Pathway

    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. Sandoz Statement The company's announcement, made 24 July 2014, says FDA has already accepted its filing for a biosimilar Neupogen (filgrastim), an FDA-approved treatment used to decrease rates of infection in patients with nonmyeloid malignancies who are already r...
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    FDA to Spend $1 Million to Develop Mathematic Model of Drug Sameness and Similarity

    Drug regulators with the US Food and Drug Administration (FDA) are pursuing the development of new technologies to better understand generic—and perhaps even biosimilar—drugs. In a 19 May 2014 funding announcement posted on the National Institute of Health's website, FDA explained that it's seeking help in developing a mathematical algorithm or model it can use to integrate various information to better understand which data can demonstrate "similarity or sameness of t...
  • As Biosimilar Problems Emerge, EMA Looks to Create Quality Comparability Guideline

    The European Medicines Agency (EMA) has released a new concept paper calling for the development of a new framework to help solve one of the most difficult challenges associated with the development of biosimilar and biological products: ensuring that the quality of the biological product meets intended standards at all times during the development process. The concept paper , released on 28 June 2013, explains that EMA has received several requests in recent years rega...
  • Industry Calls for Changes in Biosimilars Meeting Guidance to Protect Data, Provide Clarity

    In April 2013, the US Food and Drug Administration (FDA) released the fourth in a series of draft guidance documents related to the emerging regulatory framework for biosimilar products, a product classification first passed into law in 2010. Now industry is weighing in on that guidance, saying it needs several major changes in addition to a host of minor clarifications. Background Biosimilars were first identified as a unique regulatory classification under the 2010 P...
  • New EMA Guideline Establishes Framework for Biosimilars, Use of International Comparator Studies

    The European Medicines Agency (EMA) has just published a new biosimilars draft guideline for consultation that outlines the general principles that industry must take into account when developing an application to the agency. Background Generic products have long been an integral part of the pharmaceutical ecosystem. Starting in the 1980s, frameworks were set up around the world to allow for generic pharmaceutical companies to make chemical copies of existing drugs afte...
  • FDA Releases Fourth Biosimilar Guidance Outlining New Types of Meetings

    The US Food and Drug Administration (FDA) has released a fourth and long-anticipated draft guidance document pertaining to the regulatory pathway for biosimilar products, this time on how sponsors should plan to interact with regulators in the context of formal meetings before and during the review of a regulatory application. Background The draft guidance, released on 1 April 2013, is only the fourth to be released since the biosimilars pathway was created under the ...
  • Updated Draft Guidance Describes Process for Dispute Resolutions for Drug Products

    The US Food and Drug Administration (FDA) has released a new draft guidance that describes the process by which those in the biopharmaceutical industry can initiate and elevate disputes regarding drug and biological products. The guidance is intended to apply to FDA's Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), the two centers responsible for the review and evaluation of nearly all of the drug and biological...