• 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

Over the next five years, the purchase and production of biosimilar drugs can expect to see double-digit growth. As biosimilar drugs become more widely produced, prescribed, used, and accepted, the competitive marketplace will continue to heat up. What are the drivers for biosimilar drug production? And what trends are having an impact on the industry? Here’s a look at today’s landscape — and a peek into what we can expect in the near future.

Trend: The Quest for Market Share

As the patents of blockbuster biologic drugs expire, there will be new opportunities for companies to use reference biologics to create biosimilar drugs. By 2020, $67 billion in biological patents will run out, including those for Lantus and Avastin, which collectively had over $8 billion in sales in 2013. 

While some drug makers are in the process of or have already created biosimilars for popular biologics, they can’t be marketed until the patents expire. For example, Mylan and Momenta Pharmaceuticals are teaming to create a number of biosimilars that have complicated IP landscapes, which stand in the way of market entry for a decade or more. At stake for each biosimilar can be multi-billion dollar markets — which has not only pharmaceutical giants but also smaller, pure play companies fighting for the right to develop biosimilars.

Trend: The Case for Less Clinical Data

The strength of the CMC and comparative analytics package greatly influences the probability of approval for biosimilars. In accordance with the “totality of evidence” concept, strong CMC/analytical package will reduce the burden of proof on clinical data the first generation of biosimilars, which consist of molecules with lower molecular weights. Accordingly, biosimilar developers should embrace an optimized regulatory strategy, which suggests higher investment in CMC/comparative analytics and PK/PD bioequivalence studies as opposed to more challenging in-patient efficacy studies. This FDA stance of “totality of evidence” is fostering increased activity within the competitive landscape from smaller companies who believe that their proven, precise development methodologies will enable them to obtain biosimilar approvals for less money.

Trend: The quest for interchangeability

The introduction of the concept of interchangeability by the FDA has put the global success of the biosimilar market on hold. This is due to the FDA’s reluctance to issue formal guidance defining the approval pathway for interchangeable biologic. While this hold is happening, other countries with centralized, one payer systems are procuring biosimilar in large lots at the most advantageous quantities and costs. As a result, patients that are being treated for chronic diseases are receiving biosimilars from different manufacturers over the course of their treatment. The post-market data produced from these patients should provide more robust evidence than any designed and controlled clinical study. It will be interesting to see what happens first. Will the FDA will issue formal guidance on an approval pathway for interchangeable biologic or will the post-market data be so compeling that they will be forced to accept all biosimilars as interchangeable by default?

The Future

Over the next two to three years, we can expect it to be significantly easier to obtain approval for first generation biosimilars in the U.S. The faster drug developers can get biosimilars through the regulatory agencies, and as the cost to develop them decreases, the greater the opportunity will be for more companies to step in and have an impact on the industry. With more companies producing these drugs, there will be more options — and this means a greater number of people will be able to reap the benefits that biosimilars provide.

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