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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA Reverses Course, Decides Not to Add Suffixes to Older Biologics’ Nonproprietary Names

    The US Food and Drug Administration (FDA) has decided not to go back and rename biologics’ nonproprietary names with nonsense suffixes, as it once said it would, raising questions about the confusion that will likely come from a subset of biologics’ and biosimilars’ names containing suffixes while another subset of biologics’ names will not contain suffixes. Since 2015, FDA has been adding the meaningless suffixes to biosimilars' nonproprietary names as part of an effor...
  • Regulatory NewsRegulatory News

    EU Takes Another Step Towards Adopting SPC Waiver Proposal

    The European Union’s proposal to allow manufacturing waivers to supplementary protection certificates (SPC) is one step closer to adoption after EU ambassadors endorsed a compromise reached on 14 February with the European Parliament during a meeting of the Committee of the Permanent Representatives (Coreper) on Wednesday.   Now that the draft regulation has been agreed to, it will undergo a legal and linguistic review before being sent to the European Parliament and C...
  • Regulatory NewsRegulatory News

    Canada Steers Away From Using Suffixes in Biologics' Names

    Canada has decided to not use suffixes in the non-proprietary names of biologics or biosimilars, making the US the only country in the world to use such suffixes. “Following internal and external stakeholder consultations and analysis of related issues, Health Canada has decided that biologic drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix,” a notice to stake...
  • Regulatory NewsRegulatory News

    Drugmakers Debate Whether Parts of FDA’s Biosimilar Guidance are Unconstitutional

    Drugmakers and trade groups have raised questions with two US Food and Drug Administration (FDA) guidance documents on biosimilars, including one explaining how FDA plans to transfer drugs previously approved under new drug applications (NDAs) to be biologic license applications (BLAs). On this so-called “Deemed to be a License” guidance , which explains the NDA to BLA transition, all but one of the biopharma companies and industry groups took issue with the agency’s a...
  • Regulatory NewsRegulatory News

    Shakeup at the Top of FDA’s Biosimilars Division

    The US Food and Drug Administration (FDA) on Friday announced that Leah Christl, director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs (OND), has decided to leave FDA and will depart 22 February. Christl is moving to Amgen. Amgen told Focus Christl will be joining as executive director, global regulatory and R&D policy on 11 March. After joining FDA in 2003, Christl since 2010 has been at the forefront of biosimilar policy an...
  • Regulatory NewsRegulatory News

    House, Senate Hearings Address Pharmaceutical Prices

    The House Oversight Committee and the Senate Finance Committee on Tuesday held hearings addressing the rising cost of prescription drugs, with both committees featuring mothers of insulin-dependent children, including one whose daughter died because of rationing due to the cost of insulin. Senate Finance Chair Chuck Grassley (R-IA) and others stressed the need for an investigation into the rising cost of insulin. “We need to continue to have a strong research engine ...
  • Regulatory NewsRegulatory News

    European Commission Focuses New Report on Pharma Competition Enforcement

    The European Commission (EC) on Monday released a report on pharmaceutical competition enforcement activities by the Commission and EU member states' national competition authorities from 2009 to 2017.   The 46-page report was put together in response to concerns voiced by the European Council and Parliament in 2016 and 2017 regarding anticompetitive practices within the pharmaceutical sector, such as tactics to delay generic competition, pay-for-delay arrangements...
  • Regulatory NewsRegulatory News

    Mini-Exodus From Biosimilar Space Stirs Questions

    In just the past month, three companies have all exited the biosimilar space in one way or another, which has some questioning whether expectations for the biosimilars markets need to be adjusted. The slide began early last month when Sandoz halted its submission for biosimilar rituximab in the US after the Food and Drug Administration (FDA) requested additional information. Stefan Hendriks, global head of biopharmaceuticals at Sandoz, said he believes the needs of...
  • Regulatory NewsRegulatory News

    Generic and Branded Industry Groups Spar Over EU SPC Waiver Proposal

    The European Parliament’s International Trade Committee (INTA) on Monday voted to adopt a draft opinion supporting changes to an amendment that would allow for manufacturing waivers to supplementary protection certificates (SPCs).   In the EU, SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse be...
  • Regulatory NewsRegulatory News

    Boehringer Cites ‘Massive’ Number of Patents in Humira Biosimilar Suit

    As six companies have now settled with AbbVie over when they can launch their Humira (adalimumab) biosimilars in 2023, Germany-headquartered Boehringer Ingelheim continues to wrangle in court with the Chicago-based AbbVie.   According to documents released Wednesday from the suit between Boehringer and AbbVie, Boehringer said AbbVie’s generalizations “are unproductive and inaccurate.” The comments from both sides offer a window into a dispute that’s continued now for m...
  • Regulatory NewsRegulatory News

    Mylan and Novartis to FDA: Where are the Suffixes?

    Mylan and Novartis are taking issue with the fact that the US Food and Drug Administration (FDA) has yet to begin issuing random suffixes for biologics’ names and so far has only used suffixes for biosimilars and a few recently approved biologics, according to comments released Wednesday. “The agency has not yet retroactively issued suffixes to any reference product for which there is a corresponding biosimilar. Given the agency's silence about this practice, there are ...