• Regulatory NewsRegulatory News

    Six Lawsuits Target AbbVie’s Humira and its Patent Thicket

    The city of Baltimore, the largest grocery-worker union in New York and at least four other health plans have filed lawsuits against AbbVie over the past several weeks, alleging the Chicago-based company’s blockbuster Humira (adalimumab) should already have biosimilar competition in the US. One of the lawsuits, brought on by UFCW Local 1500 Welfare Fund, the New York grocery-worker union, argues that AbbVie should be held accountable for its thicket of patents and recen...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: Everything You Need to Know About Biosimilars

    For more than a decade now, biotech and pharmaceutical companies have brought a new class of treatments – biosimilars – to markets around the world (from the EU to India to South Korea to the US), offering cost savings for some of the most expensive medicines, though even in 2016, decades after companies began their quest to develop biosimilars, they are still only just beginning to see widespread adoption. What is a Biosimilar? A biosimilar medicine (also sometimes k...
  • Regulatory NewsRegulatory News

    FDA Updates Orange Book With Patent Submission Dates

    As part of efforts to increase transparency and generic drug competition, the US Food and Drug Administration (FDA) is publishing patent submission dates to help generic drug manufacturers determine the earliest date when they may be able to market new generics. FDA began collecting the patent submission date data in 2013, and the agency says there are about 4,000 patent records for which submission dates are available. The update is the result of a final rule fr...
  • Regulatory NewsRegulatory News

    US Supreme Court: No Six-Month Wait for Biosimilars After FDA Approval

    The US Supreme Court on Monday ruled unanimously that biosimilar companies will not have to wait an additional six months after US Food and Drug Administration (FDA) approval before launching their new biosimilars. The case, pitting biologics manufacturer Amgen against Novartis subsidiary and biosimilar manufacturer Sandoz, attempted to clarify what’s known as the biosimilars "patent dance," which is the process by which companies must exchange and figure out the pa...
  • Feature ArticlesFeature Articles

    Strategies Adopted by Innovator Companies in Response to Biosimilars Competition

    This article examines key strategies being adopted by the innovator companies and discusses the impact these strategies are likely to have on the future market for biosimilars. Introduction Over the last 25 years, biologic medicines have transformed how several chronic and life-threatening diseases are treated. Because of the great value of these innovative biologic medicines and the capital required to bring them to market, they are able to command high prices. For e...
  • Regulatory NewsRegulatory News

    US Supreme Court to Review Biosimilar ‘Patent Dance’

    The US Supreme Court on Friday said that it will review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products. The decision will not only have an impact on how biosimilar developer Sandoz and biologics company Amgen move forward in their interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) but on the US biosimilar industry as a whole. T...
  • Regulatory NewsRegulatory News

    EU Pharma Patent Settlements Still Limiting Entry of Generics

    Almost three-quarters of 125 patent settlements in the EU in 2015 between originator pharmaceutical and their generic competitors resulted in a lengthening of time to bring the cheaper generic version to market. But of those 74%, only 10% were settlements limiting generic market entry and including a payment or transfer of value from originator to generic company, while 64% were settlements limiting generic entry but with no value transfer. The remaining 26% of settlemen...
  • 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

    Senate Committee Considers Priority Reviews to Stem the Tide of Off-Patent Drug Price Hikes

    Sens. Susan Collins (R-Maine) and Claire McCaskill (D-Mo.) hosted a hearing Wednesday to discuss steep price increases for some off-patent drugs and what can be done to ensure patients and hospitals can afford these drugs moving forward. The hearing, which is the first in a series that focuses on companies that, as Collins puts it, “act more like hedge funds than pharmaceutical companies,” follows letters sent to four specific companies – Valeant Pharmaceuticals, Turin...
  • 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

    Bayer, Boehringer Latest to be Hit by Indian Patent Office Decisions

    In two recent decisions, India’s patent office struck major blows to German drug makers Bayer and Boehringer Ingleheim, saying their respective patents for Nexavar and Spiriva fail to meet the inventiveness requirements under the country’s controversial Patents Act . Background India’s patent system has been a source of frustration for western drug makers, who have argued for intellectual property (IP) reform in the country. India is also listed on the US Trade Repre...
  • Mylan Sues FDA, Seeking Earlier Approval for Generic Celebrex

    Generic pharmaceutical manufacturer Mylan says it plans to sue the US Food and Drug Administration (FDA) after regulators declined to grant 180 days of market exclusivity for its generic version of Pfizer's Celebrex (celecoxib). Background Under the 1984 Hatch-Waxman Act , companies are allowed to file for approval for a generic version of a drug once the original product's patent and market-based exclusivity provisions end. To incentivize companies to challenge the va...