• Regulatory NewsRegulatory News

    Cyltezo approved as interchangeable biosimilar with Humira

    An anti-inflammatory biosimilar from Boehringer-Ingelheim has received interchangeability designation from the US Food and Drug Administration (FDA).        Cyltezo (adalimumab-adbm) is now both biosimilar to and interchangeable with Abbvie’s Humira (adalimumab), announced FDA, which had granted biosimilar status to Cyltezo in 2017. Cyltezo is approved for all indications for which Humira can be used, including several inflammatory arthritides, Crohn’s disease and ulce...
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    FDA approves Semglee as first biosimilar interchangeable insulin

    The US Food and Drug Administration (FDA) has approved the first interchangeable biosimilar product, giving the designation to a once-daily insulin product to treat diabetes.   FDA’s designation of Semglee (insulin glargine-yfgn, Mylan) as interchangeable with Lantus (insulin glargine, Sanofi) means that Semglee may now be substituted for the reference product at the pharmacy “without the intervention of the prescriber,” noted FDA in a Wednesday evening press release ...
  • 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...
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    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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    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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    Novo Nordisk Warns of Possible Cracks in Insulin Devices

    Novo Nordisk A/S on Wednesday warned people with diabetes that it has detected that the insulin cartridge holder used in a select number of NovoPen Echo and NovoPen 5 lots may crack or break if exposed to certain chemicals, including certain cleaning agents. Novo spokesman Ken Inchausti told Focus that this is a global recall. Certain lots of the two devices distributed in Canada were the subject of an initial warning . Other lots distributed in the US were par...
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    New Maryland Law to Restrict Generic Drug Price Increases

    A new Maryland law to keep generic drug prices from increasing by too much goes a step further than price transparency bills and laws in other states, but it’s leaving some with more questions about its broader impact. Just before the weekend, Maryland Gov. Larry Hogan (R) allowed the generic drug price gouging bill, HB 631 , to become law, though he did not sign the bill and expressed reservations about "unintended consequences." In a letter to the Maryland Spea...
  • Feature ArticlesFeature Articles

    Insulin: The First Truly Miracle Drug

    This article will discuss diabetes, the process of the discovery of insulin and provide brief biographies of two intrepid people involved. Introduction Although a number of so called blockbuster drugs claim to be miracles, none has yet reached the status of injectable insulin. It was the first drug to treat diabetes mellitus that could virtually raise the dead, enabling dying children to laugh and play again and to lead a somewhat normal life. 1 Insulin transforms a ...
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    MHRA Cautions Against Sudden Switches of Insulin Devices

    The Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday said it has become aware of patients directly contacted by a manufacturer or other organization inviting them to trial a new insulin delivery system. “It is crucial people do not suddenly stop using or change their insulin devices without first discussing it with their diabetes specialist,” the regulator says. The caution comes as MHRA warns that patients who suddenly stop using or change their ...