Answers to frequently asked questions about BBCIC:
- What is a biosimilar and a biologic?
- What exactly is the BBCIC?
- Why do we need BBCIC?
- Where do the data come from?
- Are there other organizations conducting similar post-market surveillance?
- What is AMCP’s role?
- How are BBCIC research priorities identified?
- What say do the participants have in BBCIC’s decision to initiate a project?
- How is the research disseminated?
- Does BBCIC comply with HIPAA?
- Does Europe have a BBCIC?
- What value do participants get from BBCIC?
- What is the BBCIC’s process for reporting adverse events if identified in studies?
- Does the BBCIC have a strategy for addressing data lags?
- Are both biosimilars and biologics studied?
- What progress has the BBCIC made on its research plans?
- Is a BBCIC Participant permitted to request and receive de-identified data from the BBCIC?
- Is a Participant permitted to analyze any de-identified data from the BBCIC?
- What is the fee to participate?
- How can my organization join BBCIC?
To learn more about biosimilars and biologics, please visit our Biosimilars Facts page.
The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) is a multi-stakeholder, research consortium focused on generating scientific evidence on biologics, including biosimilars, and establishing a transparent, science driven approach to using real-world data.
BBCIC is a public service initiative that draws on de-identified health care data covering over 90 million patient lives in the BBCIC Distributed Research Network (DRN), that leverages the infrastructure and tools developed by the U.S. Food and Drug Administration (FDA) Sentinel Initiative. The BBCIC provides unbiased scientific information on the effectiveness and safety of marketed biologics, including biosimilars. The scale and focus of the BBCIC and the DRN on biologics are unprecedented.
The BBCIC is funded through sponsorships of more than 15 diverse organizations, including managed care and integrated delivery networks, pharmacy benefit management firms, research institutions and pharmaceutical companies. Revenue is gathered solely to support the mission and activities of BBCIC. This consortium model allows for a larger voice with more credibility. Diversity of stakeholders in the consortium ensures scientific rigor and trust in the validity of the findings.
The BBCIC harnesses cutting-edge distributed research network technology and surveillance methods to provide the reassurance that patients, physicians, and other decision makers need to ensure safe and effective use of biologics, including biosimilars.
Generics made a significant contribution to public health by providing access to safe and effective medications that have saved the US over $1.6 trillion in past decade. Similarly, biosimilars share the potential promise of improved access to life-saving biologic treatment, at a significant cost savings. Some estimates forecast a potential $250 billion savings over the next 10 years. However, slow market uptake has resulted in delayed benefits to the US health care system.
BBCIC is facilitating the introduction of biosimilars by conducting rigorous research to provide real-world evidence of the safety and effectiveness of biologics, including biosimilars.
The BBCIC Distributed Research Network (DRN) includes 2 of the largest health insurers - Aetna and Anthem, with Humana available for projects as needed – as well as three regional health plans and integrated delivery networks - HealthPartners, Harvard Pilgrim, and Kaiser Permanente Washington Health Research Institute. Together these research partners contribute data from insurance claims for nearly 95 million patient lives.
BBCIC leverages the analytic tools and infrastructure built by the U.S. Food and Drug Administration (FDA) through the Sentinel Initiative. This allows us to efficiently and cost-effectively conduct research at a very large scale utilizing data harmonized into the Sentinel Common Data Model. We have access to the same analytical tools and strategies employed by the FDA to meet their goal of ensuring the safety of medicinal products in the United States.
Additionally, we are constantly evaluating other existing data sources to identify opportunities to enrich the data in the current BBCIC DRN, and expand BBCIC research capabilities. For example, work is underway to expand the BBCIC DRN to include data that will allow more robust investigation around clinical outcomes in oncology. An important role for the BBCIC’s multi-stakeholder Planning Board and Science Committee is developing and prioritizing strategies to close data gaps.
While BBCIC primarily uses an existing distributed research network (DRN) infrastructure, we have confirmed with many stakeholders including the U.S. Food and Drug Administration (FDA) that our use of a DRN to focus squarely on biologics, including biosimilars is unprecedented. The FDA’s Sentinel Initiative is a post-market surveillance system that tracks the safety of pharmaceuticals and other therapies once they reach the market. Similarly the Innovation in Medical Evidence Development and Surveillance (IMEDS) is a public-private partnership by the Reagan-Udall Foundation that leverages the Sentinel infrastructure to conduct post-market research; however, the BBCIC differs from Sentinel and IMEDS in that the BBCIC is the only research network focused solely on biologics. Also, BBCIC is the only to follow a true consortium model where all participant organizations share an equal voice in the planning and conduct of all BBCIC research.
AMCP initiated this effort by being the neutral convener of a diverse group of health care stakeholders. To bring this project forward, AMCP formed the AMCP BBCIC, LLC, which ensures a scientific, unbiased approach to monitoring biologics. The consortium model of managed care organizations, integrated delivery networks, pharmacy benefit managers, medical societies, patient advocacy groups, researchers, and biopharma allows for a larger voice with more credibility.
AMCP has made a long-term commitment to the BBCIC. The original BBCIC business plan was a three-year plan that is now updated yearly.
The BBCIC Charter outlines an organized process for characterizing patient populations and generating evidence for biologics and biosimilars in a manner that promotes robust and relevant scientific research with the goal of making meaningful contributions to the scientific record. The BBCIC research framework gives surveillance priority to biologics, including biosimilars.
Study ideas and research topics are regularly solicited from BBCIC participants. Any individual from BBCIC participant organizations is invited to propose a research question for consideration. The BBCIC Science Committee, which includes a seat for every participant organization, reviews research proposals for relevance to the BBCIC scope of inquiry, and prioritizes all projects according to the overall research agenda. The BBCIC Planning Board, which also includes a seat for all participant organizations, then reviews the research priority list recommended by the Science Committee to ensure consistency with the scientific relevance and available resources.
This BBCIC is a multi-stakeholder consortium dedicated to providing real world evidence on biologics, including biosimilars. The BBCIC Charter recognizes that all stakeholders should have a voice in the discussion, but no single stakeholder group should dominate the discussion. The Charter and Policies and Procedures ensure that the BBCIC remains fair and balanced, science-driven and in the best interest of public health, assuring balanced scientific discussion on all committees and Research Teams. BBCIC Participants are committed to constructive, scientific dialogue.
All participant organizations have a seat on each of the BBCIC Governance Committees: Planning Board, Science Committee, and Communications Committee. Therefore, all participants have a voice in identifying the research priorities and proposing research topics. Additionally, all participants can join any research team that is of interest, ensuring the multi-stakeholder strength of BBCIC is carried throughout all activities.
BBCIC is committed to transparency in all aspects of its research and operations. We communicate in a variety of ways with the external scientific and medical community and with the public. The BBCIC observes standard academic practices and regulatory requirements regarding its obligation to report research activities and findings.
All research protocols are reviewed and approved by the BBCIC Science Committee. Once approved, protocols are results are posted to www.clinicaltrials.gov to ensure transparency, and that research is conducted with academic freedoms to maintain scientific integrity without bias.
Additionally, per the BBCIC Charter, protocols and study results are posted to www.bbcic.org and/or published in a peer reviewed journal. The BBCIC Communications Committee is responsible for creating and implementing an overall communications and media engagement plan for all BBCIC work, and each research team is expected to have a plan for timely dissemination of all research-related activities.
Yes. Health information that is subject to a BBCIC project is entirely de-identified. The BBCIC does NOT receive or possess personally identifiable information (PII), as defined by the Privacy Act of 1974 or Protected Health Information as defined by HIPAA in the conduct of its activities. BBCIC follows the approach established for the FDA Sentinel Initiative that protects the privacy and security of individual health information. All research information is provided in summary format, no patient level data is sent to the BBCIC.
Not yet. Internationally, there are many product- or disease-specific registries, and some rich sources of medical data, but their data have not been harmonized across sources. There are some efforts underway in Europe to harmonize data across country and regional systems similar to efforts undertaken by the US Food and Drug Administration in development of the Sentinel Common Data Model, but it will be some years before unified data are available in Europe.
Currently, the BBCIC does not have any international data partners. Our participants and researchers work with international surveillance teams and should collaboration be necessary, we believe we have the contacts to make this happen expeditiously. We also periodically revisit the needs and interest in international partnerships.
Many pharmaceutical companies expect to continue to be innovators (i.e., novel biologics), but there may come a time when their innovator products become reference products for biosimilars. Both originator and biosimilar manufacturers are engaged in developing the biologic marketplace. Pharmaceutical companies and other organizations participating in BBCIC demonstrate their commitment to advancing the science of real-world evidence. By participating in the BBCIC, organizations demonstrate the value of multi-stakeholder engagement to customers, the government, and the public at large. BBCIC demonstrates that the efforts of our participants are aligned with the need for safe and affordable biologic drugs.
We call this a ‘finding of interest’ and define it as “information that arises from an observational study, which suggests a new potentially causal association, or a new aspect of a known association, between an intervention and an event or set of related events, either adverse or beneficial.” Any identification by the BBCIC Research Team of a potential safety-related finding of interest will be based on the Research Protocol which will explicitly pre-specify the clinical expert judgment, epidemiologic and statistical thresholds required to identify a safety-related finding.
If a potential for harm is discovered by a BBCIC Research Team via the process of scientific discovery, the Science Committee will contact the relevant manufacturer’s pharmacovigilance team to report BBCIC’s findings. The Science Committee may authorize additional work to assist the licensed manufacturer in meeting reporting obligations to the relevant regulatory authority. BBCIC will coordinate additional outreach to patients, stakeholders and most importantly regulatory bodies (e.g., the FDA).
This is a challenge to conducting large-scale observational research using administrative or medical claims. There is a data lag that is typically around 6 months, but may range from 3 months to 12 months, depending on the data refresh cycles of the research partners. As a result, there is a delay in our ability to conduct research. Furthermore, the utilization of biosimilars in the US has been much more sluggish than initially anticipated, and BBCIC is unable to conduct an analysis until adequate utilization is observed in the Distributed Research Network (DRN).
BBCIC regularly conducts “Monitoring” or “Utilization” studies, which are simple analyses to assess the number of patients and products of interest identified in the DRN. This activity supports planning efforts for BBCIC research, as we can identify when sufficient patients and treatment episodes are available in the data, but it also provides a useful clinical picture over time for treatment and utilization patterns in the US.
Yes. While BBCIC was initially convened with a focus on comparative evaluation of biosimilars with their reference products, the scope of research includes study of any biologic product, including biosimilars.
Please visit our Research page for more information on BBCIC research projects.
Currently any research conducted by the BBCIC needs to be approved by the Science Committee and subsequently the Planning Board. Once approved, BBCIC Research Teams are formed and are responsible for writing detailed Protocols that define the data and epidemiology/statistical approaches. All Participants are able to designate an individual to serve on a Research Team, and as such have access to the data. Participants also have opportunity to lead a Research Team as a Principal Investigator or Co-Principal Investigator. The final Protocol and research report is prepared by the Principal Investigator and Research Team and is fully transparent.
Within the confines of the Protocol, Research Team Participants are responsible for analyzing the de-identified data. Data extraction and analysis is conducted based on approved BBCIC research, and person-level data are generally not available to BBCIC or it’s participants.
Participation in BBCIC is on an organization, rather than an individual basis, and fees are structured accordingly. Multiple individuals from a participant organization may be active members of BBCIC through allotted seats on the three BBCIC Governance Committees, as well as joining research teams for any projects of interest. Currently, fees are assigned on a sliding scale based on the overall revenue of your organization.
The annual participant fees are pooled, and all funds directly support the conduct of BBCIC research.
Please contact Executive Director Cate Lockhart, PharmD, PhD, at firstname.lastname@example.org if you are interested in more information!
We look forward to hearing from you!