• Regulatory NewsRegulatory News

    Leaked TPP Chapter on IP Sets Terms of Biologics Data Exclusivity

    Information on biologics data exclusivity provisions in the Trans-Pacific Partnership remains murky, despite a leaked copy of the final version of the TPP Chapter on Intellectual Property rights from WikiLeaks on Friday. The section of the chapter on biologics data exclusivity seems to offer two options with respect to the "first marketing approval" of a new biologic: that countries involved shall provide "effective market protection…for a period of at least 8 years from...
  • Regulatory NewsRegulatory News

    Final TPP Agreement Draws Ire from Both Sides over Biologics Exclusivity

    Pharmaceutical industry groups and nonprofits expressed disappointment Monday over a compromise in the Trans-Pacific Partnership (TPP) on biologics data exclusivity. The deal, which has previously stumbled over the issue of biologics data exclusivity, would either provide eight years of exclusivity to biologic drugs, or provide five years of exclusivity, plus up to three more years under a regulatory framework for the 12 countries in the trade bloc, which includes the ...
  • 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...
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    FDA Plans New Regulation on Fixed-Dose Combinations, Co-Packaged Drugs

    • 22 May 2015
    The US Food and Drug Administration (FDA) plans to release two new regulations by the end of 2015, it announced this week. The announcement, contained in the latest edition of the US Unified Agenda , contains 33 proposed and final rules FDA says it hopes to publish by the end of calendar year 2015. In practice, however, some rules have remained on FDA's Unified Agenda for years. FDA's latest update of the Unified contains two additional regulations compared to its las...
  • Feature ArticlesFeature Articles

    China New Drug Applications 2004–14: Regulatory Considerations for Clinical Development Supporting Their Approval

    Local clinical data are essential as supporting evidence for new drug applications (NDAs) in China. This article reviews the clinical development process of 148 new chemical entities (NCEs) and new therapeutic biological products approved in China from 2004 through mid-2014. It provides insights into critical regulatory considerations influencing the number of clinical trial patients and choice of development pathway needed to gain regulatory approval in China. Ch...
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    The Top 15 Biologics Deficiencies Cited by FDA in 2014

    The US Food and Drug Administration (FDA) has released data on the observations it makes during inspections of biologics manufacturing facilities, indicating the most common issues faced by biologics companies. Total 483s Issued Declines for First Time in Six Years In its most recent report, FY 2014 Inspectional Observation Summaries , FDA said it issued 146 Form 483s—forms indicating areas of noncompliance at a facility—to biologics companies in fiscal year 2014. T...
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    Sandoz First Company to File for Biosimilar Approval in US Under New Pathway

    Biopharmaceutical company Sandoz, a Novartis subsidiary, has announced that it has filed the first-ever biosimilar application in the US with the Food and Drug Administration (FDA) using its 351(k) pathway. Sandoz Statement The company's announcement, made 24 July 2014, says FDA has already accepted its filing for a biosimilar Neupogen (filgrastim), an FDA-approved treatment used to decrease rates of infection in patients with nonmyeloid malignancies who are already r...
  • Bill Would Create Incentives to Seek New Approvals for Old Biologics

    A new bill introduced in the US House of Representatives on 24 March 2014 would grant companies additional patent protections for repurposed biological products. Bill Basics The bill, the Independent Innovator and Repurposing Act (IIRA) , is cosponsored by Reps. Joaquin Castro (D-TX) and Randy Forbes (R-VA) and is intended to provide "appropriate intellectual property protections" for some products. Those products, the bill explains, are any biologicals regulated un...
  • CBER to Join Growing Ranks of FDA's Consolidated White Oak Campus

    The US Food and Drug Administration's (FDA) sprawling White Oak campus will soon absorb one of the agency's largest main regulatory divisions, it has announced The White Oak campus , located in Silver Spring, MD, is meant to consolidate all of FDA's headquarter operations in one place. Previously, FDA has offices throughout the Washington, DC metro area, making it difficult for different divisions of FDA to meet with one another in person. Starting in May 2014, FDA's C...
  • New Guidance Provides Framework on How to Keep a Drug the Same over Time

    A new draft guidance document released by the US Food and Drug Administration (FDA) is meant to clarify the analytical procedures and methods used to validate the production of drugs and biological products. Background The guidance was last issued in final form in 1987-26 years ago-and in draft form in 2000. Validation procedures and methods are important in the production of pharmaceutical products because they allow a company and regulators to say, with certainty, th...
  • EMA Continues to Seek Guideline on Similarity Criteria for Biosimilars

    The European Medicines Agency (EMA) has formally issued a call for a reflection paper on methods to compare quality attributes in drug development, saying that regulators need to settle on established criteria for determining acceptable ranges of "similarity criteria" in biosimilar products. Background The draft of the concept paper was released in May 2013, and explained that EMA has received several requests in recent years regarding the adequacy of data ...
  • As FDA Considers First Wave of Biosimilar Drugs, Are States Limiting Their Eventual Impact?

    • 05 September 2013
    One of the biggest changes to food and drug law changes by the 2010 passage of the Patient Protection and Affordable Care Act (PPACA), better known by most as Obamacare, was its provisions for the creation of a "biosimilars" pathway under Section XII of the law. But now one of the most influential states in the US is moving to restrict their eventual use, conceding arguments made by innovative biopharmaceutical manufacturers that physicians should be able to restrict th...