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  • 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 ...
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    Belgium Inspects Companies Delaying or Preventing Biosimilar Competition

    The Belgian Competition Authority (BCA) said recently that it’s inspecting the premises of companies suspected of using restrictive practices to limit, delay or prevent the entry of biosimilar competition. While the authority did not offer any details into what companies are being inspected, the authority did say that this is a preliminary step into its investigation of such restrictive practices. “Conducting inspections does not prejudge the outcome of the investiga...
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    Will Some Biologics Get 30 Years of Exclusivity?

    As the wrangling over the US-Mexico-Canada trade agreement continues, a provision to require Mexico and Canada to accept 10 years of biologic exclusivity stirred up controversy because it would be two more years than what Canada currently enjoys and add five more years for Mexico. In the US, biologic exclusivity is set at 12 years. But in reality, a 30-year run for a biologic without competition is possible, following a court win for Amgen last August. And 15-plus y...
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    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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    Here Come the Oncology Biosimilars in the US: How Low Will Prices Go?

    A quick look at biopharma’s top-selling drugs (including forecasted sales through 2024) reveals a trio of biologic cancer treatments that have been marketed since 1997 and will likely bring in a cumulative total of more than $300 billion. But biosimilar competition for Roche’s Herceptin (trastuzumab), Avastin (bevacizumab) and Rituxan (rituximab) is now ready to launch in the US, and Bernstein biopharma analyst Ronny Gal said in a report issued Friday that prices over...
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    Another Biosimilar Approval From FDA, Another Unknown Launch Date

    The US Food and Drug Administration (FDA) on Friday approved Pfizer’s Zirabev (bevacizumab-bvzr), the 21 st biosimilar in the US and the second for Roche’s cancer treatment Avastin (bevacizumab). But the launch date in the US for Zirabev, a treatment for five types of cancer, remains unknown, as does the launch date for its predecessor, Amgen’s Mvasi (bevacizumab-awwb), approved in September 2017. Similarly, two Enbrel (etanercept) biosimilars have been approved, the f...
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    FDA Replaces Withdrawn Biosimilar Guidance With New One on Quality-Related Considerations

    A week after finalizing guidance on developing interchangeable biosimilars, the US Food and Drug Administration (FDA) has drafted guidance for biosimilar developers on the use of comparative analytical studies that can be used to assess whether a proposed product is biosimilar to a reference product. The 28-page draft guidance revises a final guidance from 2015 on quality considerations for demonstrating biosimilarity and serves as a replacement for a 2017 draft gui...
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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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    FDA Approves 18th Biosimilar, 4th for Herceptin

    The US Food and Drug Administration (FDA) late Monday approved the 18 th biosimilar, Pfizer’s Trazimera (trastuzumab-qyyp), which is the fourth approved in the US for Roche’s Herceptin (trastuzumab). Pfizer told Focus it’s working to make Trazimera available to patients as soon as possible but could not provide a specific launch date. The biosimilar is approved for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 ...
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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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    Industry Groups Call on FDA to Dispel Biosimilar Misinformation

    The Association for Accessible Medicines (AAM) and its Biosimilars Council, as well as the pharmacy benefit manager association, the Pharmaceutical Care Management Association (PCMA), are backing a Pfizer petition that calls on the US Food and Drug Administration (FDA) to do more to counteract untruthful or misleading information on biosimilars. The AAM comment, related to Pfizer’s petition , specifically targets the term “non-medical switching” and the concept of inte...
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    FDA-tasked Mitre Forges Ahead with Cyber Vulnerability Scoring System Tailored to Devices

    Under a US Food and Drug Administration (FDA) contract, a new rubric developed by the Mitre Corporation is the first-of-its-kind to be specifically tailored to medical devices, and is set to take the form of a medical device development tool (MDDT) to ensure consistency in scoring cybersecurity risks. The common vulnerability scoring system (CVSS) open standard for assessing software vulnerability severity has seen widespread use on an international scale since its 2005...