• About
    • About Biorasi
      • Meet Biorasi

        Biorasi, founded in 2002, has partnered with global
        sponsors to enable FDA, EMA, and multi-venue
        approvals for numerous small molecules and
        biologics. Headquartered in Miami, Florida,
        Biorasi maintains office-based teams
        around the globe.

    • Our People
      • Cultivating The Future

        Biorasi hires the best – from industry and regulatory agency veterans to promising young talent on the rise. Biorasi’s leadership is made up of forward-looking visionaries with an unparalleled commitment to excellence in the services we provide to our sponsors and partners.
    • Our Board
      • Leading the Industry

        Our board is comprised of some of the most brilliant minds working in biopharma. Our directors and advisers help guide the company and act as a vital strategic asset both for Biorasi and our sponsors.
    • Careers
      • Careers

        We are looking to hire the best from inside and outside the industry. If you have an unparalleled commitment to excellence, a passion for making life better, and a drive for success, we’d like to talk to you.
  • Services
    • Study Rescue
      • Study Rescue


        Biorasi has a long track record of being able to
        right faltering programs. We have worked both
        as an integrated CRO, adding our strengths
        to a trial’s incumbent CRO, as well as a
        transition CRO, by assuming primary
        study management responsibility
        from the incumbent organization.

        Read how Biorasi can
        help rescue your trial

    • Project Management
      • Project Management

        We believe that only fundamentally sound project management can ensure trial success, and that only properly trained project managers, backed up by industry-leading processes, and innovative tools, can ensure sound project management.

    • Regulatory Services
      • Regulatory Services

        Regulatory affairs strategy is one of the biggest hurdles in running clinical trials. Increased trial complexity, regulation, and the need for multi-venue approval are driving this trend. Biorasi’s regulatory team has worked with regulatory agencies around the globe, including the most difficult venues.

    • Safety
      • Safety and Pharmacovigilance

        Biorasi’s best-in-class processes and technologies help our team identify safety trends and risks in sponsor studies quickly, and give us insight on how to resolve them without risking the trial. Fast detection, fast response, and fast resolution ensure our trials always stay on time.

    • Data Science/Biometrics
      • Data Science & Biometrics

        We make trial data an integral part of guiding trial success. Biorasi builds out standard data structures from the beginning and uses big data-style analytics to make your data immediately useful. This front-loaded approach saves sponsors time and money and minimizes risks.

    • Quality Assurance
      • Quality Assurance

        Biorasi is constantly evolving and improving, always under the guidance of quality first. Our quality team audits our internal functions as well as our sponsor studies to make sure that plans and SOPs are adhered too.

    • Program Development
      • Program Development

        We look at your projects in a global context. Biorasi’s consulting services are built around the idea that trials only realize their maximum value when they part of an optimized and effective holistic drug development program.

  • Therapeutic Areas
    • Autoimmune
      • Autoimmune

        Autoimmune is one of the fastest-growing areas of clinical research, due to increased recognition and incidence of autoimmune diseases i. Biorasi can help with all aspects of managing your next autoimmune trial.

    • Dermatology
      • Dermotology

        Dermatology trials have some very unique challenges. From difficulty in enrolling to compliance in a patient population that is typically much younger than other trials, Biorasi knows how to make your dermatology trial a success.

    • Nephrology
      • Nephrology & Pain

        Biorasi is a leading CRO in nephrology and dialysis-dependent CKD populations. No one understands the nuances of research in the dialysis population better than we do, and no one conducts these studies with our level of professionalism, and attention to the special needs of these patients.

    • Neurology
      • Neurology Trials

        Biorasi’s project managers and clinicians understand the complexities of neurodegenerative, pain, and psychiatric disorders. Our unique positioning and experience, coupled with our strong network and relationships with specialized sites give us an unparalleled advantage in neurology trials.

    • Oncology
      • Oncology Trials

        Many CROs specialize in oncology, however few have the versatility to offer full-service trial management like Biorasi. Find out how our integrative approach to oncology makes a real difference in the success of your next oncology trial.

    • Women's Health
      • Women’s Health Trials

        Trusting your women’s health trials to an expert like Biorasi guarantees every trial you run will be optimized. With years of experience and a broad portfolio of past studies, Biorasi is your best partner in women’s health clinical research.

    • Medical Devices
      • Medical Device Trials

        Medical devices are a unique field with a unique approach to regulatory approvals and clinical trials. Biorasi combines deep expertise in the specialized area of medical devices, and combines it with decades of therapeutic area excellence with our industry leading methodology.

  • Technology
    • Talos Technology

      An increasingly connected world can make your clinical trials better or just more complex. Our TALOS™ Technology Platform is built to take connections and turn them into insights, increase efficiencies and help us deliver optimized solutions for every sponsor.

      Learn More

  • Resources
  • Contact

Co-authored by Stephanie Finnegan, President Divisional Operations and Dominique James, Editorial Analyst

On March 6th, 2015 the FDA announced approval of the first Biosimilar drug in the United States. The similarities between follow-on drugs and follow-on biologics make Specialty Pharmaceutical companies dominant among candidates to successfully usher in this new era of biologics. Biobetters and 505(b)(2) drugs are expected to be advantageous in comparison to the original products in one or more features other than simply cost savings. Thanks in large part to the enabling Hatch-Waxman legislation (1984) generic drugs (505(j)/ANDA) are substitutable at the pharmacy level; without prescriber authorization. Automatic substitution has been generally accepted by the market because the maturity of the generic drug market has demonstrated the only significant difference between the generic and the reference listed drug is cost. However, Biosimilars have no paradigm in the established Specialty Pharmaceuticals industry. They offer some (although less dramatic) manufacturing and development savings but have not won market confidence which fosters “pharmacy swap” benefits with no significant product improvement over the reference biologic. This means they must be marketed and sold as a “stand-alone option” prescribed by name only with a lower price tag being the lone benefit.

Some forecasts suggest the industry will evolve into a model similar to the small-molecule drug industry. Current trends in Europe indicate Biosimilars have not been making the large market share gains predicted. They have proven to be very expensive to bring to market, costly to produce, highly competitive and encumbered by costs of sales, marketing and distribution. The world is waiting to see what happens when the FDA begins to approve many of these Biosimilar molecules and a viable US market begins to emerge.

Lots of questions! Will the changing healthcare model in the US drive legislation similar to Hatch-Waxman for Biosimilars? Will the Federal government over-turn many of the states that have already legislated against automatic substitution without authorization? In the most sophisticated healthcare market in the world, will payers, physicians, and patients accept without question the safety and efficacy of these new molecules?

We believe Biosimilars early adaption and clinical trials in the United States are a first step in the development and maturation of the follow-on biologics market. Facilitating legislation will most likely be passed to enable market penetration and this will benefit sponsors worldwide. In addition, we remain confident markets will also develop strongly for Biobetters and Interchangeables. Market exclusivity and ease of substitution of Interchangeables render financial incentives which will drive pioneering companies to engineer interchangeable molecules from initial transfection and work with CRO partners who demonstrate they’re clinically interchangeable. Our biologics teams use TALOS™ to provide clients with innovative study designs for Biosimilar and Biobetter approval, as well as options for designs to demonstrate interchangeability. These options offer the ability to weigh risk vs. reward and to make optimal decisions for follow-on biologics programs.

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