• 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

In 2006, the European Medicines Agency granted its first approval of a biosimilar drugthe human growth hormone, Omnitrope™ (Sandoz), and opened the doors of opportunity for this emerging field of medicine. In 2010, President Obama signed into law the Biosimilars Act, and on March 6, 2015, the FDA formally approved its first biosimilar drug, Zarxio™, which is used, among other things, to stimulate the growth of infection-fighting white blood cells in cancer patients. Over the course of just a decade, biosimilar drugs have gained global momentum, driven by the promise to help populations around the world; biosimilars are projected to become a $390 billion market by 2020.

Biologics 101

Biosimilars are biological drugs that are highly similar to biotherapeutics, also known as biologics. These complex drugs are made from, or expressed by, a living system, such as a microorganism, animal, plant, or human. They work with the body to address the underlying disease, rather than just the symptoms of the condition. As such, biologics are less toxic than chemically synthesized medicines and hold the great potential to treat many unmet medical needs.

Biologics work in one of three ways:

  • Increase the cellular response to a molecule stimulus, known as upregulation (Example: Erythropoietin, a drug that treats anemia)
  • Decrease the number of cellular components that responds to an external variable by a process called downregulation (Example: Infliximab, which treats rheumatoid arthritis, among other illnesses)
  • Augment the body’s natural defense mechanisms (Example: Factor VIII, which is used to stimulate clotting)

How Biosimilars are Made

A biosimilar drug is made by copying an approved biologic drug — a process similar to the way generic drugs are made after approved small molecule drugs. With generics, small molecule drugs are synthesized by chemical reactions to create a chemical entity. A different company can make this entity in a different facility using the same synthesis methods. Think of this as one-to-one matching.

Although the process to create biosimilars is comparable to generics, it’s important to remember that because biosimilars are made from living hosts, one company’s drug will be inherently different than another company’s drug. This is because small, transient changes that occur in the host cell, or happen during manufacturing, will cause changes in the final product, which is referred to as post-translational modifications. You can find examples of these changes in glycosylation patterns (the way in which a carbohydrate is attached to a hydroxyl or other group), or the different ways that proteins will fold. As such, it’s impossible to make biosimilars identical because there will always be some degree of variance.

Steps to Creating a Marketable Biosimilar

To create a biosimilar, an existing drug is selected as a target and then its chemistry, manufacturing, and controls are replicated. Once the biologic patent is expired or deemed invalidated, the biosimilar can be tested to demonstrate its equivalency to the biotherapeutic drug. This includes any number of in-vitro (in a laboratory bench-top setting) or in-vivo (in live animals) tests where the biosimilar product and the innovator biologic are examined side by side and the results are compared against one another. At the final stages, the two products (the biosimilar and the innovator biologic) may be tested in one or more studies in human subjects, often using patients suffering from a disease to evaluate the therapeutic effect of the biosimilar.

If everything proceeds as planned, the final step is to register the biosimilar for sale in the market. While these steps may appear expeditious to some, each one is complex, costly and time-consuming. Adding to the complexity is the fact that drug approvals and regulations from product to product and from country to country are not standardized — and as such, process efficiencies are certainly lacking.

The Potential of Biosimilars for Health and Business

However, the excitement about biosimilars is building globally because of their power to increase access to life-saving drugs for people around the world — by increasing supply and lowering costs. And because there is no shortage of living hosts, biosimilars will reduce the possibility of drug shortages for necessary medications.

While the cost to produce biosimilars is higher than with generics, and the process for creation much more difficult, these drugs offer greater returns because the tepid competitive environment allows for higher profit margins. As a large number of biologic drugs are going off-patent in the next few years, including Enbrel™ and Humira™, there will be billions of dollars at stake. According to IMS Health, by 2020, biologics are expected to account for 28 percent of the global pharmaceutical market spending, and the biosimilar market will grow to $390 billion. But that’s not the grandest prize.

While biosimilars is a large, high-growth market with increasing worldwide acceptance and infinite opportunity, the potential to increase patient quality of life and promote longevity its real value.

For more on this topic, download the full report, “Biosimilars: An Emerging New Opportunity.”

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