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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Updated: Duplicate MAAs: Amgen Wins EU-wide Approval for Two Humira Biosimilars

    The European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars for Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab). Amgevita is authorized for all of the same indications as Humira, while Solymbic, which won approval through a duplicate marketing authorization application (MAA), is authorized for all indications except polyarticular juvenile idiopathic arthritis. Duplicate MAAs: Public Health or Co-Mar...
  • Regulatory NewsRegulatory News

    FDA Approves Third Biosimilar in US, First for Amgen's Blockbuster Enbrel

    The US Food and Drug Administration (FDA) on Tuesday approved Sandoz’s biosimilar to Amgen’s blockbuster Enbrel, which will be known as Erelzi (etanercept-szzs) for all indications included in the reference product’s label. Erelzi is the second biosimilar approved via the Biologics Price Competition and Innovation Act in the US from Sandoz (the first was for Zarxio (filgrastim-sndz), which is biosimilar to Amgen's Neupogen). The approval of Erelzi follows a unani...
  • Regulatory NewsRegulatory News

    Back to Back: FDA Panel Offers Unanimous Thumbs Up for Sandoz’s Enbrel Biosimilar

    For a second straight day, the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee unanimously pushed for the approval of a new biosimilar, this time for Sandoz’s biosimilar for Amgen’s blockbuster Enbrel (etanercept). Wednesday’s vote – 20-0, with no abstentions – comes on the heels of Tuesday’s 26-0 vote i n favor of approving Amgen’s biosimilar for AbbVie’s blockbuster Humira (adalimumab) . The discussion of Sandoz’s biosimilar was also less focuse...
  • Regulatory NewsRegulatory News

    FDA Staff: Sandoz’s Enbrel Biosimilar is ‘Highly Similar’ to Amgen's Blockbuster

    Another clear sign that the US biosimilars market is off to a good start appeared on Monday, with staff of the US Food and Drug Administration (FDA) concluding that Sandoz’s biosimilar, known currently as GP2015, and Amgen’s blockbuster Enbrel (etanercept) are “highly similar.” “In considering the totality of the evidence submitted, the data submitted by the Applicant [Sandoz] show that GP2015 is highly similar to US-licensed Enbrel, notwithstanding minor differences i...
  • Regulatory NewsRegulatory News

    Biosimilars in the EU: Lower Costs, Increased Patient Access, IMS Report Finds

    For those tracking the contentious debate over drug and biologic price hikes in the US, an IMS Health report released on Monday offers the latest evidence yet that a robust biosimilars market can not only lower prices across drug classes but also increase patient uptake of such treatments. “The increased competition affects not just the price for the directly comparable product but also has an effect on the price of the whole product class,” the report says. “In countr...
  • Regulatory NewsRegulatory News

    European Commission Clears First Enbrel Biosimilar Ahead of US

    The European Commission over the weekend signed off on the first biosimilar for Amgen’s blockbuster rheumatoid arthritis treatment Enbrel, a version of which is also making its way through a separate review by the US Food and Drug Administration (FDA). With almost $5 billion in annual sales last year (and almost $9 billion in 2014 sales), the biosimilar version of the treatment from Samsung Bioepis, known commercially as Benepali (etanercept), could help to drive down pr...