MENUMENU
  • 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

        PUTTING STALLING TRIALS BACK ON TRACK

        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

With a global market of USD 3.3 billion during 2016 and a forecast surpassing USD 10.5 billion by 2023, Biosimilars have received more than their fair share of hype in the pharma world due to the undeniable value they bring to the healthcare system in terms of lowering insurance and drug cost on the patient. By definition, a Biosimilar is a “biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product”. Hence, a Biosimilar has almost the same chemical identity, structure, purity and bioactivity as the reference product. Nonetheless, since Biosimilars are produced via “artificial” biological methods (i.e. cells), small differences in the structure are unavoidable and so a Biosimilar is treated differently than their small molecule counterparts (i.e. generic drugs). These differences are tolerated as long as they exhibit no difference in pharmacokinetics, pharmacodynamics, safety, tolerability and efficacy as compared to the reference products.

 

From Biosimilar to Interchangeable

Despite their characteristics, Biosimilars are only given to patients under explicit prescription, naming the Biosimilar per se. To maximize the benefits and cost savings presented by Biosimilars, the notion of Interchangeability has been gaining in prominence. Interchangeability allows pharmacists to provide Biosimilars instead of Reference drugs even if the reference drug’s name is on the prescription. If you have ever been given a choice by your pharmacist to get the “generic” versus the “brand” then you have experienced this phenomenon with a small molecule drug prescription. Interchangeability became the holy grail of the Biosimilar world as it is crucial for rapid market penetration, however no one has attained the designation in the US and the FDA has not laid out a clear path for it. Without the “Interchangeable” designation, a Biosimilar manufacturer would have to create a huge sales task force which will have to actively promote the Biosimilar to the doctors: an arduous task that many manufacturers either don’t have the resources to achieve or would love to avoid.

Only this year has FDA released a draft guidance on Interchangeability for Biosimilars. This guidance contains exceedingly rigorous requirements insuring that any Biosimilar going for the designation of “Interchangeable” produces the same clinical result as the reference product in any given patient.

 

Current state of the market for Interchangeable Biosimilars

Currently, only 5 Biosimilars are present in the market. None are designated Interchangeable. However, recent information indicates that there are at least 14 Biosimilar applications. Among those, only 2 Biosimilars were used in switching studies, which could support an interchangeable designation in those cases. With the FDA draft guidance for Interchangeability now available, the path forward to interchangeability has cleared up a bit to allow many of the current and future applications to go for the Interchangeable designation. Hence, we should expect that at least some Interchangeable Biosimilars will hit the market in the very near future.

 

Tackling Interchangeability

Based on the FDA guidance, for a Biosimilar to be Interchangeable it needs to pass much more complex requirements than for standard approval. For example, in order to demonstrate safety and efficacy for drugs that are administered more than once to a patient, the risk of switching Biosimilar and reference products must not exceed the risks of using the reference alone, and that is in all the indications approved for the reference drug. To note, the FDA guidance clearly specifies that only the U.S. version of the reference product should be used in these studies.

As for Biosimilars that are already in the market, the FDA guidance notes that post-market data collected from those products is not enough to determine Interchangeability, although it can be helpful in pinpointing what remaining study data needs to be generated to support Interchangeability. For example, post-marketing data could reveal certain safety risks that otherwise would not show up during the reference initial clinical trials due to the lower numbers of patients investigated. Thus, these safety risks can be taken into account in the design and execution of the required switching clinical study.

The draft guidance also emphasizes that the presentation and design attributes of the proposed Interchangeable product should be the same as the reference product in an effort to simplify substitution. This reasoning applies to container closure systems and delivery devices, as well.

Finally, the FDA expects that Interchangeable Biosimilars applications will require a lot of interaction with the sponsor. Thus, to facilitate the development of safe and effective biosimilar products for the American public, the FDA enacted the assessment and collection of fees for biosimilar biological products from October 2017 through September 2022. The fees are dedicated to expediting the review process for biosimilar biological products. Moreover, the FDA will be able to hire more staff, enhance meetings with industry on their biosimilar applications and offer written responses to questions when meetings might not be necessary, among other improvements.

 

Conclusion

Undoubtedly, this last draft of the FDA guidance on Interchangeability will have a significant and far-reaching impact on the healthcare system overall. The “Interchangeable” designation of a Biosimilar, appropriately adopted, will make it much easier to dispense effective and less costly drugs to patients and hence lower the overall health burden on millions of individuals with chronic disorders. More interestingly for the state of the industry, this draft guidance opens the door to more biosimilars entering the market, and a renewed push to develop and ramp up biosimilars programs. While the initial draft guidance is very narrow and presents a very complicated path to market, it has opened the door to revised guidances that may open the floodgates completely on interchangeability. Or it may remain very limited in scope and effect, rewarding only the companies that make the extra effort. Either way, this is the time to take a firm accounting of your biosimilar program, or to have a serious conversation about starting one up, before the opportunity passes.

Download a Sample Rescue Trial Report

Please provide your email address so we can email your sample rescue trial report.