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  • Regulatory NewsRegulatory News

    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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    FDA Approves 20th Biosimilar, 5th for Roche’s Herceptin

    The US Food and Drug Administration (FDA) on Thursday approved Amgen’s Kanjinti (trastuzumab-anns), which is the fifth biosimilar to be approved for Roche’s Herceptin (trastuzumab) and 20 th biosimilar overall. Although none of the five Herceptin biosimilars have launched in the US yet, the first launches are expected soon. Roche has settled three court cases with Pfizer, Mylan and Biocon, and Celltrion and Teva. Roche also said publicly that it expects competition s...
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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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    FDA Approves Eighth Biosimilar, First for Cancer Drug Herceptin

    The US Food and Drug Administration (FDA) on Friday approved the first biosimilar to Roche’s blockbuster breast and stomach cancer drug Herceptin (trastuzumab). Mylan and Biocon’s biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India. First approved in the US in 1998, Herceptin had US sales of more than $2 billion for the 12 months ending 30 September 2017, according to IQVI...
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    FDA Panel Unanimously Backs Avastin and Herceptin Biosimilars

    The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday unanimously backed the approval of biosimilar versions of two of Roche's top selling cancer drugs, Avastin (bevacizumab) and Herceptin (trastuzumab). In the morning session, ODAC members voted 17-0 in favor of approving Amgen's Avastin biosimilar candidate, ABP 215, for six of Avastin's indications. However, the committee did not consider whether Amgen's data would support a...
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    NICE, Roche Reach Deal on Breast Cancer Drug

    Patients in the UK could soon get access to Roche's targeted breast cancer drug Kadcyla (trastuzumab emtansine) through the National Health Service (NHS) as early as next month, the National Institute for Health and Care Excellence (NICE) said on Thursday. Currently, the UK pays for Kadcyla through its Cancer Drugs Fund, which requires patients to apply for funding to get access. The announcement comes just six months after NICE issued its second draft guidance rejecti...
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    WHO to Begin Cancer Biosimilar Prequalification Pilot This Fall

    The World Health Organization (WHO) on Thursday announced it will invite biosimilar makers to participate in a pilot program to prequalify biosimilars of two top selling biologics this September in an effort bring lower cost versions of the products to low- and middle-income countries. The two cancer treatments—Roche's Rituxan (rituximab) and Herceptin (trastuzumab)—make the top ten list for highest grossing drugs worldwide and cost in the tens of thousands of dollars pe...
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    Asia Regulatory Roundup: Indian Watchdog Probes Allegations Roche Tried to Influence Regulators (2 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Indian Antitrust Watchdog Probes Allegations Roche Tried to Influence Regulators The Indian antitrust watchdog has begun an investigation into allegations Roche tried to influence regulatory agencies and otherwise stop biosimilar copies of Herceptin from gaining market share. Roche is accused of seeking to influence the office of the Drug Controller General of India (...
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    European Regulatory Roundup: EMA Begins Review of First Herceptin Biosimilar (1 September 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EUnetHTA Nears Start of Third Phase of HTA Cooperation Agenda The European network for Health Technology Assessment (EUnetHTA) is on the cusp of entering the third phase of its agenda. Members of the European Commission and the Dutch National Health Care Institute began a 30-day countdown to the official start of the program by signing a grant agreement.  When the of...
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    India Releases New Biosimilars Guidance

    India’s Central Drugs Standard Control Organization on Saturday released new guidance for biosimilar developers as new biosimilars come to market there before other regions, and as India's regulators look to develop more specific guidance on postmarketing studies. The new document is a slight tweak of previous guidance issued in 2012 , but includes several important changes that are now up for discussion through 30 April. India's biosimilars market currently includes ei...
  • EU Regulators Warn of Counterfeit Copies of Cancer Drug Herceptin

    EU regulators have issued a warning that several batches of the cancer medicine Herceptin (trastuzumab) have been "tampered with," falsified and reintroduced into the supply chain, potentially putting patients at risk. Background High-cost cancer medications like Herceptin have become an increasingly tempting target for thieves and counterfeiters in recent years. While they lack the ready market that some drugs like Viagra have, their extraordinary cost means extraordin...
  • Non-Proprietary Name Confusion Leads to Safety Warning for New Breast Cancer Drug

    What's in a name? While Shakespeare tells us that a rose by any other name would smell just as sweet, a newly approved drug is finding out that a similar-sounding non-proprietary name has the potential to cause some very sour problems in the form of potential mix-ups and safety problems. The drug in question is Kadcyla (ado-trastuzumab emtansine), a new breast cancer therapy for patients with HER2-postive, metastatic breast cancer that did not respond to prior treatments...