• Regulatory NewsRegulatory News

    Biosimilar ‘Patent Dance’: Federal Circuit Rules 180-Day Notice is Mandatory

    The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration (FDA) review. The ruling has major implications for when biosimilars can be launched and it follows the US Supreme Court’s request in late June that th...
  • Regulatory NewsRegulatory News

    TransCelerate Progress on Trial Efficiencies Unimpeded by Pharma Regulators

    The joint efforts of 18 biopharmaceutical companies, under the umbrella of TransCelerate BioPharma, are continuing to advance their efforts in sharing data, making clinical trials more efficient and working with drug regulators around the world to ensure that progress enables change that can help patients. The group is working to leverage the data and best practices of its members, such as Pfizer, Amgen, AstraZeneca, Merck and Roche, across a wide swath of trial-relate...
  • Regulatory NewsRegulatory News

    How a Fax Caused the Federal Circuit to Invalidate a Patent for Two Bayer Oral Contraceptives

    The US Court of Appeals for the Federal Circuit on Friday ruled that a Merck KGaA patent - linked to two of Bayer’s oral contraceptives, Safyral and Beyaz - is invalid because ingredients in the drug were offered for sale before the filing of the patent. The reversal of the lower court decision could mean a loss of patent protection and the launch of new Safyral and Beyaz generics before the patent expires in April 2020. The story and patent claim on the contraceptives...
  • Regulatory NewsRegulatory News

    Sandoz Petitions Supreme Court to Rule on Biosimilars

    Novartis' Sandoz has called on the US Supreme Court to review a lower court ruling that found biosimilar makers must wait an additional six months after US Food and Drug Administration (FDA) approval before they can bring their product to market. The petition for the Supreme Court’s review deals with Sandoz’s Zarxio (filgrastim-sndz), which came to market as a biosimilar version of Amgen’s Neupogen (fligrastim). Although FDA approved Zarxio in March 2015 as the first bio...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: UK’s NICE Takes Sides in PCSK9 Market (11 February 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. NICE Takes Sides in Fight for PCSK9 Market, Recommending Amgen While Rejecting Sanofi The National Institute of Health and Care Excellence (NICE) has recommended using Amgen’s PCSK9 inhibitor Repatha in certain indications, while rejecting the use of Sanofi and Regeneron’s rival drug Praluent. While both manufacturers offered discounts of undisclosed magnitudes, only A...
  • 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...
  • Regulatory NewsRegulatory News

    FDA Likely to Require Substantial Clinical Data for Interchangeable Biosimilars, Lawyers Say

    The US Food and Drug Administration (FDA) is “almost certain” to require clinical data in order for companies to demonstrate interchangeability between a biosimilar and its reference product, though the question of how much data will be required is major factor in determining how quickly the US biosimilars market will take off, according to a new report from the law firm Goodwin Procter. The Biologics Price Competition and Innovation Act (BPCIA) of 2010 established th...
  • Regulatory NewsRegulatory News

    GPhA’s Biosimilars Council: BPCIA Provides 12 Years Exclusivity, Not 12.5

    The Generic Pharmaceutical Association’s Biosimilars Council is taking issue with a recent court decision that could effectively delay the launch of biosimilars in the US by an additional six months, according to an amicus brief. Background Under the Biologics Price Competition and Innovation Act (BPCIA) -- authorized as part of Obamacare -- biosimilars can be approved via an expedited pathway and then marketed after their reference biologics are exclusively marketed fo...
  • Regulatory NewsRegulatory News

    US, EU Face Off Over Permanently Exempting Least-Developed Countries from Pharma Patents

    Tomorrow and Friday, members of the World Trade Organization (WTO) will meet to discuss whether the world's poorest countries should be permanently exempt from rules governing pharmaceutical patents, and the EU and US have publicly taken separate sides. Background Since the initial WTO agreement on Trade-Related Aspects of IPRs (TRIPs) in 1995, least-developed countries (LDCs) have been granted exemptions from implementing intellectual property (IP) rules for pharmaceut...
  • Regulatory NewsRegulatory News

    Landmark EU Court Ruling Ends Uncertainty Over Duration of Biotech Patent Protection

    Pharmaceutical and biotech companies are cheering a ruling issued earlier this week by the Court of Justice of the European Union (CJEU) that essentially adds up to a couple days' worth of patent protection to medicinal products, but could mean millions of Euros for the companies. The ruling is concerned specifically with Supplementary Protection Certificates (SPCs), which extend the duration of certain rights associated with a patent and are typically provided to compe...
  • Regulatory NewsRegulatory News

    US, Switzerland Campaign to End 20-Year Moratorium on Non-Violation Complaints to WTO

    At the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) meeting last week, the US and Switzerland called on the Council to end a 20-year moratorium on what are called "non-violation complaints," LiveMint reports. While non-violation complaints were rare even before the moratorium, they could provide a way for countries to challenge controversial intellectual property provisions such as Section 3(d) of India's Patents Act . Background Non-v...
  • Regulatory NewsRegulatory News

    Biologics Exclusivity Still Central in Trade Talk Debate

    The length of data exclusivity for biologics remains one of the most controversial aspects of the Trans-Pacific Partnership (TPP), which is poised to be the largest free-trade deal in history. While the US Trade Representative (USTR) and the biopharmaceutical industry have publicly called for a 12-year exclusivity period, Politico reports that some industry lobbyists are tempering their expectations. Background Among the 12 parties to TPP, the United States is the on...