• Regulatory NewsRegulatory News

    Where are the Interchangeable Biosimilars?

    In June 2017, Leah Christl, former biosimilar lead at FDA, told a conference in Chicago that interchangeable biosimilars were likely coming to the US market within two years . And although no interchangeable biosimilar has been approved by FDA yet, and Christl has since moved on to Amgen , progress on interchangeable biosimilars has been made, albeit slowly, in the intervening years. Most recently, Boehringer Ingelheim announced that it has completed , as of last ...
  • Regulatory NewsRegulatory News

    House Bill Aims to Cut Insulin List Prices to 2006 Levels

    As patients who need insulin to live continue to struggle to obtain the increasingly costly injections, Rep. Diana DeGette (D-CO) introduced a bill this week to lower insulin list prices to 2006 levels. The shift to 2006, according to DeGette, would lower the average list price for a vial of insulin from about $300 to approximately $68. A report released Thursday by the White House explains how in recent years the list price of insulin has increased dramatically, w...
  • Regulatory NewsRegulatory News

    Insulin Competition: FDA to Hold Public Meeting

    As insulin products continue to remain unaffordable for many, the US Food and Drug Administration (FDA) on 13 May will hold a day-long public meeting to discuss access to insulin and issues related to the development and approval of competitor products, including biosimilar and interchangeable insulin products. "We’re already seeing robust activity among sponsors seeking to bring forward biosimilar copies of insulin. The framework for demonstrating that these insulin pr...
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    Senators Seek Changes to FDA Guidance to Speed Entry of Insulin Biosimilars

    As Eli Lilly announced Monday that it would introduce an authorized generic version of its Humalog insulin at half the original price, four senators on both sides of the aisle are seeking tweaks to recent US Food and Drug Administration (FDA) guidance to speed up the marketing of new biosimilar insulin products. The guidance is part of FDA’s work to begin, starting in March 2020, transitioning approved marketing applications for a subset of products, including insulin...
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    House E&C Questions Insulin Manufacturers

    The House Committee on Energy and Commerce (E&C) on Wednesday sent letters to the three insulin manufacturers serving the US: Eli Lilly, Novo Nordisk and Sanofi, seeking more information on the root causes of the rising cost of insulin. First discovered more than 100 years ago, average insulin prices nearly tripled between 2002 and 2013 and then nearly doubled between 2012 and 2016, with patients bearing the brunt of those price spikes. Now, just a day after two moth...
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    European Commission Updates Q&A on Safety Features for Medicinal Products

    The European Commission recently released an updated document setting out nine new and one revised frequently asked questions and answers on the implementation of the rules on the safety features for medicinal products for human use. Building off a previous update in November , five of the new questions deal with general issues, like whether medicinal products can carry more than one batch number, or whether during the transitional period manufacturers located in the E...
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    Industry Proposes Changes to FDA’s FIH Expansion Cohort Guidance

    Industry and oncology groups are calling for changes to the US Food and Drug Administration’s (FDA) recently released draft guidance on first-in-human clinical trials for oncology drugs that feature multiple expansion cohorts.   The 17-page draft guidance, released in August 2018, provides recommendations to sponsors on the design and conduct of such trials, which the agency says can “expedite development by seamlessly proceeding from initial determination of a poten...
  • Feature ArticlesFeature Articles

    Successful Human Factors Programs: Key Considerations from a Regulator's Perspective

    This article provides two regulatory leaders insight on human factors engineering considerations for helping manufacturers optimize user interfaces and successfully meet regulatory expectations to bring safe, effective and usable medical devices to market. It was developed from an interview with Shannon Hoste, team lead of the Center for Devices and Radiological Health's (CDRH's) human factors premarket evaluation team and Michael Ryan, acting deputy director in the divi...
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    French Regulators Set Up Dedicated Unit for Overseeing Early Stage Clinical Trials

    France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) last week announced that it is setting up a new unit dedicated to overseeing first-in-human and other early stage clinical trials. The new unit is part of ANSM's action plan created in response to an incident during a first-in-human trial in France that left one patient dead and five others hospitalized in early 2016. The incident sparked an investigation by ANSM and a led to the Europe...
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    Updated: The 505(b)(2) Pathway and Why Some Follow-on Insulins Aren’t Yet Biosimilars in the US

    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. In September, FDA granted tentative approval for Sanofi’s Admelog (insulin lispro injection), a rapid-acting human insulin analog. On 11 December, Admelog received full approval from FDA. In the EU, howe...
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    UK’s MHRA Unveils Human Factors Guidance for Medical Devices

    As part of its work to minimize the risks from use error and promote safe practices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released new guidance on human factors and usability engineering for medical device manufacturers. The guidance, intended not just for manufacturers of all device classes and drug-device combination products but notified bodies too, offers a look at the UK’s regulatory framework, comparisons of different ...
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    FDA Finalizes HPV Diagnostic Study Guidance

    The US Food and Drug Administration (FDA) on Thursday finalized its 2015 draft guidance on the types of studies necessary to establish the performance characteristics of diagnostics used to detect human papillomavirus (HPV) when screening for cervical cancer. Background HPV is the leading cause of cervical cancer, with fourteen genotypes of the virus considered to be carcinogenic or high-risk. According to the Centers for Disease Control, cervical cancer was the leading...