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  • Regulatory NewsRegulatory News

    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to US Food and Drug Administration’s (FDA) regulations, announced Tuesday, are designed to remove unnecessary or outdated biologics requirements and allow industry to employ new manufacturing technology and testing capabilities.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...
  • Regulatory NewsRegulatory News

    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    The US Food and Drug Administration (FDA) today released a new draft guidance document intended to explain how biological products approved under Section 351(a) of the Public Health Service Act (PHS Act) are given periods of market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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Biopharmaceutical Manufacturer Admits Faulty Data Reporting, Blames Contractor

    • 24 September 2012
    Biologics manufacturer Peregrine Pharmaceuticals' has informed its investors that its second-line lung cancer drug bavituximab, for which the company just released phase IIb data showing evidence of efficacy, is plagued by faulty data it says is the result of poor work by a third-party clinical trials contractor. In its 24 September release, Peregrine said it discovered the deficient data when preparing for an end-of-phase II meeting with the US Food and Drug Administrat...
  • European Commission: Non-EU Reference Product OK for EU Biosimilars

    The European Commission plans to allow the use of a reference product not authorized in the EU in support of a biosimilar application, according to a  speech  delivered by Health and Consumer Policy Commissioner Dalli at the 18thEuropean Generic Medicines Association Annual Conference. Dalli announced "that after careful analysis of the scientific and regulatory elements, the European Commission will revise its interpretation" of existing EU law. The details o...
  • FDA Warning Letter Cites Company for Breaking HCT/P Regulations

    A warning letter sent to the company Young Medical Spa by the US Food and Drug Administration (FDA) cites the company for violating minimal manipulation regulations governing the use of human cells, tissues or cellular and tissue-based products (HCT/Ps). FDA's warning letter specifically cites Young's Owner and Medical Director Thomas E. Young for removing, reprocessing and injecting patients with their own adipose tissue (lipoaspirate), from which Young isolated stem ce...